Daily Archives: March 17, 2022

Phase 2b clinical trial of PN-235, an oral IL-23 receptor antagonist, has launched with a target enrollment of 240 patients

NEWARK, Calif., March 16, 2022 /PRNewswire/ --Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") announced today earning a $25 million milestone payment from its collaboration with Janssen Biotech Inc., (Janssen), following dosing of the third patient in the Phase 2b FRONTIER 1 clinical trial of PN-235 (JNJ-77242113).

"The start of this Phase 2b study in moderate-to-severe plaque psoriasis marks an exciting moment along the development pathway for this promising drug candidate, discovered through Protagonist's proprietary technology platform," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "Advancing PN-235 aligns with our shared goal with Janssen to develop new therapies with transformational potential for patients in need."

FRONTIER 1 is a Phase 2b multicenter, randomized, placebo controlled, dose-ranging study to evaluate the safety and efficacy of PN-235 for the treatment of moderate-to-severe plaque psoriasis. This study commenced on February 3, 2022 and is expected to enroll 240 participants. More information on FRONTIER 1 can be found at clinicaltrials.gov.

Protagonist has granted Janssen an exclusive worldwide license to research, develop and commercialize oral IL-23 receptor antagonists based on the Company's intellectual property. Current development efforts are centered on PN-235, discovered by Protagonist and further developed in collaboration with Janssen.

Protagonist is eligible for up to approximately $850 million in development-related milestone payments, in addition to $112.5M in milestones already earned. Under terms of the collaboration, Janssen will conduct all future clinical studies, inclusive of Phase 2 and 3 studies. Janssen will be financially responsible for such studies.

About Protagonist

Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based new chemical entities in different stages of clinical development, all derived from the Company's proprietary technology platform.

Protagonist's pipeline includes rusfertide, an investigational, injectable hepcidin mimetic currently in the REVIVE Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), the PACIFIC Phase 2 study in PV subjects with high hematocrit levels, and a recently completed Phase 2a study for hereditary hemochromatosis. The Company is actively initiating VERIFY, a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide.

The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943), currently in the IDEAL Phase 2 study in adults with moderate to severe active ulcerative colitis. The Company is targeting ulcerative colitis as the initial indication.

Protagonist has granted Janssen an exclusive worldwide license to research, develop and commercialize oral IL-23 receptor antagonists based on the Company's intellectual property. Current development efforts are centered on PN-235, discovered by Protagonist and further developed in collaboration with Janssen.

Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, future PN-235 clinical studies and the potential for drug candidates developed in our Janssen collaboration. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

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Protagonist Therapeutics Earns $25 Million Milestone Payment from Janssen Biotech for Dosing of Third Patient in Phase 2b Clinical Trial of PN-235 in...

LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that new data from the Phase 3 PSOARING 3 long-term extension study of tapinarof cream for the treatment of plaque psoriasis in adults (PSOARING 3), will be presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting, to be held March 25-29 in Boston.

Tapinarof is a novel, non-steroidal, once-daily therapeutic aryl hydrocarbon receptor modulating agent which is formulated in a cosmetically elegant cream. It is being developed for the treatment of plaque psoriasis and atopic dermatitis. In August 2021, the U.S. Food and Drug Administration (FDA) accepted for filing the companys New Drug Application for tapinarof for the treatment of plaque psoriasis in adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022.

The following posters will be viewable in the exhibit hall at the Boston Convention and Exhibition Center:

Title: Tapinarof Cream 1% Once Daily (QD) for Plaque Psoriasis: Secondary Efficacy Outcomes from a Long-Term Extension Trial

This poster will report secondary efficacy data from PSOARING 3, including change in percentage body surface area (%BSA) affected by visit, change in Psoriasis Area and Severity Index (PASI) score by visit, and PASI response rates (PASI75 and PASI90) at Week 40.

Authors: Linda Stein Gold, M.D.; Benjamin Ehst, M.D., Ph.D.; Laura K. Ferris, M.D., Ph.D.; Philip M. Brown, M.D., J.D.; David S. Rubenstein, M.D., Ph.D.; Anna M. Tallman, Pharm.D.; Jerry Bagel, M.D.

Title: Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Dermatology Life Quality Index and Local Tolerability Scores from a Long-Term Extension Trial

This poster will report Dermatology Life Quality Index (DLQI) and local tolerability scores as assessed by both patients and investigators from PSOARING 3.

Authors: April W. Armstrong, M.D., M.P.H.; Seemal R. Desai, M.D.; Melinda Gooderham, M.Sc., M.D.; David S. Rubenstein, M.D., Ph.D.; Philip M. Brown, M.D., J.D.; Anna M. Tallman, Pharm.D.; Leon Kircik, M.D.

About Dermavants Phase 3 Program for Tapinarof in Psoriasis

Dermavants Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of two pivotal studies, PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.

PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.

PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 and completed PSOARING 3, received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim analysis results from PSOARING 3 in February 2021 and full analysis results from PSOARING 3 in September 2021.

About Psoriasis

Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.

Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavants focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The companys robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis. For more information, please visit http://www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

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Dermavant to Present New Data from the Phase 3 PSOARING 3 Long-Term Extension Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022...

Kim Kardashian just revealed some news her fans have been waiting for: Her clothing line, SKIMS, is launching a new line of swimwear. In the announcement, Kardashian posed in a striking brown suit from the collection. How does she stay so fit? Read on to see 5 ways Kim Kardashian stays in shape and the photos that prove they workand to get beach-ready yourself, don't miss these essential 30 Best-Ever Celebrity Bathing Suit Photos!

Most people might be worried about carbs, as many think they are unhealthy. However, while there are unhealthy carbs, there are also healthy carbs, which you need. Kardashian wrote on her app in 2018, that she makes sure to incorporate healthy carbs into her diet, especially after she's done an intense workout. "My trainer Mel [Alcantara] always says that before and after you train, you should eat simple carbs, like sweet potatoes, and small amounts of fat and protein, like chicken."

In the same app post from 2018, Kardashian also revealed that she makes sure to incorporate a lot of veggies into her diet. She says that she tries to include veggies into as many meals as she can, and eats them throughout her day. She writes, "You should also have veggies with your meals, since you need them to help effectively break down and absorb your protein, fat and carbs."

Kardashian works out with a personal trainer, Melissa Alcantara, to keep herself in shape. According to Alcantara, the reality star is extremely committed to working out. Alcantara says that Kardashian works extremely hard, and never cancels a training session. "Kim is super responsible, she never cancelsshe's the best client and athlete you could have," Alcantara says to Women's Health. "Once [working out is] part of your daily routine and your life, then it's not something you have to think about, you just have to do it."

Kardashian revealed in a post for her sister Kourtney's website, Poosh, that she suffers from psoriasis. She says that she isn't ashamed of this condition, and focuses on taking care of it, instead of letting it bother her. Kardashian also says that she wants other people who has psoriasis to feel the same way. "I've become extremely comfortable with my psoriasis. No matter where it is on my body, sometimes I am fine with showing it off and other times I don't want it to be a distraction, so I cover it up with body makeup. If you have psoriasis, you can't let it ruin your life or get the best of you. You have to do what you can to make sure you are comfortable but not let it take over."df44d9eab23ea271ddde7545ae2c09ec

In her post for Poosh, Kardashian revealed that there was time she thought that she had rheumatoid arthritis. She wrote that she decided to do a lot of research on it, and other conditions, in order to properly take care of herself. She also says that this research helps her take care of her psoriasis. "No matter what autoimmune condition I had, I was going to get through it, and they are all manageable with proper care. I did so much research. I realized so many people I know have suffered from lupus and psoriatic arthritis, and they have given me such great advice."

Originally posted here:
Kim Kardashian In Bathing Suit Reveals SKIMS Swim Celebwell - Celebwell

Introduction

Pediatric dermatology involves not only treating patients skin but also managing the psychosocial impact a disease has on children and their families, which can be significant. Many skin conditions have a quality-of-life (QOL) effect similar to that of systemic diseases such as renal disease, cystic fibrosis, and asthma.1 Skin diseases also can have emotional and social repercussions on the parents and caregivers of children with dermatology disorders.2,3 For pediatricians to provide optimal patient care, family support is essential.

The widely used Childrens Dermatology Life Quality Index (CDLQI), which was developed in 1995, gives the practitioner an understanding of QOL issues in children aged 4 to 16 years.4 The latest cartoon version is easier and faster for children to complete and was shown to have a score similar to the original scale.5 The questionnaire, which uses a recall period of 1 week, assesses various issues including feelings of sadness or self-consciousness, impact on friendships, bullying as a result of the disease, effects on going out or playing sports, interference with sleep, and response to treatment.4,5 Based on the scoring of the responses, the effect on QOL is stratified as none (0-1), small (2-6), moderate (7-12), very large (13-18), or extremely large (19-20).6 Findings from a 2016 meta-analysis of all studies using CDLQI, which included data from 7798 children with more than 20 conditions, concluded that most skin diseases have a major impact on QOL in a small proportion of children.7 However, further review of the literature demonstrates that skin disease has a significant impact for many children and their families.

Disease-specific scoring systems have also been developed, such as the Cardiff Acne Disability Index, the Psoriasis Area Severity Index (PASI) and Physician Global Assessment, the Infants Dermatology Quality of Life, the Childhood Atopic Dermatitis Impact Scale, the Quality of Life Index for Atopic Dermatitis, and the Dermatitis Family Impact questionnaire.8,9 These scoring systems not only help with assessing severity of disease but also give insight into QOL issues that are important for physicians to address.

This brief review discusses the QOL impact of a number of skin conditions compared with other chronic systemic diseases.

Psoriasis

Psoriasis is a chronic inflammatory disease of autoimmune etiology that is not completely curable. Seen in an estimated 0.7% of children, psoriasis has a negative impact on QOL for not only children but also their parents and caregivers, even in the presence of mild disease.10,11 Results show that 36% of parents and caregivers of children with psoriasis have anxiety and depressive symptoms.12

Compared with systemic diseases using the corresponding Childrens Life Quality Index (CLQI), psoriasis was found to have a greater impairment in QOL com- pared with enuresis, diabetes, and epilepsy.1 Psoriasis was also found to have a negative influence on physical activity, self-esteem, bullying, and stigmatization.10

Investigators of another study concluded that improvement in CDLQI scores to imply no effect (0-1) was associated with a PASI score of > 90%, (a decrease in body surface area [BSA] involvement). As a consequence, this may be advised as a reasonable therapeutic goal. It was also noted that systemic therapy including biological and conventional drugs has a better outcome compared with topical agents.13

Thus, physicians are advised to follow a combined approach including clinical therapy and QOL assessment to evaluate improvement or impairment, family counseling, and support.11,14

Atopic dermatitis

With an estimated in- creasing global prevalence of 15.5% to 20.0% among children,15,16 atopic dermatitis (AD) is a chronic skin disease with relapses and remissions characterized by a wide array of clinical presentations that vary with age, environmental triggers, and genetic predisposition. The impact on QOL was found to be greater in children with AD compared with children with systemic diseases including renal disease, cystic fibrosis, asthma, and chronic urticaria.1 AD commonly arises in early childhood, with hallmark pruritic lesions that often worsen at night. Those with active AD alone had nearly 50% greater odds of reporting sleep-quality disturbances throughout childhood compared with 80% of children who also had asthma and/or allergic rhinitis. Consequently, early diagnosis and therapeutic interventions are needed to address QOL issues.17

Recent findings also revealed a relative risk of 1.4 for learning disabilities among children with AD, an association independent of sociodemographic factors and other atopic and neurodevelopmental disorders.18 Significant positive association of atopic disease and childhood AD with memory impairment, developmental delay, and cognitive dysfunction has also been identified.19

Acne

With a global prevalence of 9.38 %20 and as one of the most common skin conditions among adolescents (findings reveal prevalence from 35% to close to 100%), acne vulgaris is rightly described this way by Sulzeberger and Zaidens: There is probably no single disease which causes more psychic trauma, more maladjustment between parents and children, more general in- security and feeling of inferiority and greater sums of psychic suffering than does acne vulgaris.21

The point estimate from 5 studies using the CDLQI to assess QOL in children with acne is 5.37; that corresponds to a small impact, but research results reveal a significant impact in terms of self-esteem, relationships, and body image.22,23 Further, it is noted that children with truncal and facial acne were twice as likely to report the impact as very large or extremely large on the CDLQI questionnaire compared with children with only facial acne.23

Acne profoundly affects self-perception, socialization, emotional health, and occupational opportunities as well as body dissatisfaction.21 It is also associated with depression and suicidal ideation.24 With these factors in mind, it is crucial for the primary care physician to provide not only dermatological care but also psychological support and counseling.24

Vitiligo

The most common cause of depigmentation worldwide, vitiligo is an acquired disorder of unknown origin and undoubtedly immunologically mediated. The disease is associated with widespread stigmatization and psychological impairment.25 Investigators who used the CDLQI questionnaire to assess QOL impairment reported a median score of 3.0.26 They also found that nearly 45.6% of children aged 0 to 6 years and 50% of participants aged 7 to 14 years were not bothered by the lesions, but 95.9% of adolescents aged 15 to 17 years were troubled. Involvement of the face and legs was most bothersome for parents. The authors concluded that self-consciousness, difficulty with friendships and schoolwork, and teasing and bullying were associated with lesions involving more than 25% BSA. Lesions on the face and arms were associated with teasing and bullying.26 Further, other investigators reported that 42% of caregivers of pediatric patients with vitiligo were reported to have anxiety symptoms, whereas 26% had depression.9

Thus, to improve QOL and create a safe environment for children with vitiligo, it is important to not only provide care for these patients and their parents but also play a larger role in educating and sensitizing the public and peer groups in schools and communities to destigmatize the condition.

Molluscum contagiosum

A skin condition of viral etiology, molluscum contagiosum most commonly affects children. It is commonly asymptomatic but may present with erythema and pruritus. On some occasions, bacterial superinfections with pain and inflammation may be seen.27

In a British study the mean time to resolution was 13.3 months which confirms its chronic nature and the need to consider impact on QOL.28 Molluscum contagiosum had a small effect on quality of life for most participants, although for 33 (11%) of 301 participants it had a very severe effect (CDLQI score >13). A greater number of lesions and secondary infection was associated with a greater effect on quality of life (H=55.8, p<0.0001).

In conclusion, 1 in 10 children with molluscum contagiosum is likely to have a major issue with their QOL, and treatment should be considered for these children especially those with a large number of lesions at visible sites. It is also important to reassure parents about the course of their childrens disease.

Warts

The human papillomavirus causes warts, a benign, common skin disease that may appear on any part of the body. Per the CDLQI scoring, in children who had lesions greater than 6 months, it was seen that nearly a third had a small effect on QOL, whereas in 5% of the children, warts had an extremely large effect. It was also noted that the greatest negative effect was seen on the symptoms and feeling scores.29

The dermatology QOL indices clearly demonstrate the importance of early diagnosis and treatment of skin disease in children. As a result, practitioners should have a low threshold to refer patients early in their course for diagnosis and management of persistent dermatologic findings.

References

1.Beattie PE, Lewis-Jones MS. A comparative study of impairment of quality of life in children with skin disease and children with other chronic childhood diseases. Br J Dermatol. 2006;155(1):145-151. doi:10.1111/j.1365-2133.2006.07185.x

2.Vivar KL, Kruse L. The impact of pediatric skin disease on self-esteem. Int J Womens Dermatol. 2017;4(1):27-31. doi:10.1016/j.ijwd.2017.11.002

3.Pustiek N, Vurnek ivkovi M, itum, M. Quality of life in families with children with atopic dermatitis. Pediatr Dermatol. 2016;33(1):28-32. doi:10.1111/pde.12698

4.Lewis-Jones MS, Finlay AY. The Childrens Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;132(6):942-949. doi:10.1111/j.1365-2133.1995.tb16953.x

5.Holme SA, Man I, Sharpe JL, Dykes PJ, Lewis-Jones MS, Finlay AY. The Childrens Dermatology Life Quality Index: validation of the cartoon version. Br J Dermatol. 2003;148(2):285-290. doi:10.1046/j.1365-2133.2003.05157.x

6.Waters A, Sandhu D, Beattie P, Ezughah F, Lewis-Jones S. Severity stratification of Childrens Dermatology Life Quality Index (CDLQI) scores. Br J Dermatol. 2010;163(suppl 1):121.

7.Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Quality of life impact of childhood skin conditions measured using the Childrens Dermatology Life Quality Index (CDLQI): a meta-analysis. Br J Dermatol. 2016;174(4):853-861. doi:10.1111/bjd.14361

8.Augustin M, Langenbruch AK, Gutknecht M, Radtke MA, Blome C. Quality of life measures for dermatology: definition, evaluation, and interpretation. Curr Derm Rep. 2012(l):148-159. doi:10.1007/s13671-012-0020-z

9.Chernyshov PV. The evolution of quality of life assessment and use in dermatology. Dermatology. 2019;235(3):167-174. doi:10.1159/000496923

10. de Jager ME, van de Kerkhof PC, de Jong EM, Seyger MM. A cross-sectional study using the Childrens Dermatology Life Quality Index (CDLQI) in childhood psoriasis: negative effect on quality of life and moderate correlation of CDLQI with severity scores. Br J Dermatol. 2010;163(5):1099-1101. doi:10.1111/j.1365-2133.2010.09993.x

11. Salman A, Yucelten AD, Sarac E, Saricam MH, Perdahli-Fis N. Impact of psoriasis in the quality of life of children, adolescents and their families: a cross-sectional study. An Bras Dermatol. 2018;93(6):819-823. doi:10.1590/abd1806-4841.20186981

12. Manzoni AP, Weber MB, Nagatomi AR, Pereira RL, Townsend RZ, Cestari TF. Assessing depression and anxiety in the caregivers of pediatric patients with chronic skin disorders. An Bras Dermatol. 2013;88(6):894-899. doi:10.1590/abd1806-4841.20131915

13. Bruins FM, Bronckers IMGJ, Groenewoud HMM, van de Kerkhof PCM, de Jong EMGJ, Seyger MMB. Association between quality of life and improvement in psoriasis severity and extent in pediatric patients. JAMA Dermatol. 2020;156(1):72-78. doi:10.1001/jamadermatol.2019.3717

14. Gonzalez J, Cunningham K, Perlmutter J, Gottlieb A. Systematic review of health-related quality of life in adolescents with psoriasis. Dermatology. 2016;232:541-549. doi:10.1159/000450826

15. Gilaberte Y, Prez-Gilaberte JB, Poblador-Plou B, Bliek-Bueno K, Gimeno-Miguel A, Prados-Torres A. Prevalence and comorbidity of atopic dermatitis in children: a large-scale population study based on real-world data. J Clin Med. 2020;9(6):1632. doi:10.3390/jcm9061632

16. Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16. doi:10.1159/000370220

17. Ramirez FD, Chen S, Langan SM, et al. Association of atopic dermatitis with sleep quality in children. JAMA Pediatr. 2019;173(5):e190025. doi:10.1001/jamapediatrics.2019.0025

18.Wan J, Shin DB, Gelfand JM. Association between atopic dermatitis and learning disability in children. J Allergy Clin Immunol Pract. 2020;8(8):2808-2810. doi:10.1016/j.jaip.2020.04.032

19. Revolutionizing atopic dermatitis, 13-14 December 2020. Br J Dermatol. 2021;184(3):e56-e121. doi:10.1111/bjd.19722

20. Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris. Sci Rep. 2020;10(1):5754. doi:10.1038/s41598-020-62715-3

21. Sulzberger MB, Zaidens SH. Psychogenic factors in dermatologicaldisorders. Med Clin North Am. 1948;32:669-685. doi: 10.1016/s0025-7125(16)35686-3

22. Tasoula E, Gregoriou S, Chalikias J, et al. The impact of acne vulgaris on quality of life and psychic health in young adolescents in Greece. results of a population survey. An Bras Dermatol. 2012;87(6):862-869. doi:10.1590/s0365-05962012000600007

23. Tan J, Beissert S, Cook-Bolden F, et al. Impact of facial and truncal acne on quality of life: a multi-country population-based survey. JAAD Int. 2021;3:102-110. doi:10.1016/j.jdin.2021.03.002

24. Misery L. Consequences of psychological distress in adolescents with acne. J Invest Dermatol. 2011;131(2):290-292. doi:10.1038/jid.2010.375

25. Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7

26. Silverberg JI, Silverberg NB. Quality of life impairment in children and adolescents with vitiligo. Pediatr Dermatol. 2014;31(3):309-318. doi:10.1111/pde.12226

27. Olsen JR, Gallacher J, Piguet V, Francis NA. Epidemiology of molluscum contagiosum in children: a systematic review. Fam Pract. 2014;31(2):130-136. doi:10.1093/fampra/cmt075

28. Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis. 2015;15(2):190-195. doi:10.1016/S1473-3099(14)71053-9

29. Akdoan N, Yldrm SK, Kltr E, Evans SE. The effect of warts on quality of life in Turkish pediatric patients. Turk J Pediatr. 2020;62(6):1028-1034. doi:10.24953/turkjped.2020.06.015

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Scrutinizing the psychosocial impact of skin diseases - Contemporary Pediatrics

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Global Psoriasis Drugs Market 2022 Analysis Report with Investment Feasibility and Trends 2028 The Bollywood Ticket - The Bollywood Ticket

Arctic Bioscience AS, a biotechnology company developing and commercializing nutraceutical and pharmaceutical products based on the unique bioactive marine compounds from herring roe, announces the European Medicines Agency (EMA) decision on the agreement of a paediatric investigation plan (PIP) for the Company's investigational medicinal product, HRO350, and on the granting of a deferral. This follows a positive opinion from the Paediatric Committee (PDCO) on the paediatric investigation plan. The paediatric investigation plan outlines the company's intention to investigate HRO350 for children with psoriasis.

The Paediatric Committee of the EMA facilitates the development and availability of medicines for children, and provides opinions on the quality, safety and efficacy of a medicine for use in the paediatric population. As part of drug development programs, pharmaceutical companies must submit a paediatric investigation plan outlining the strategy for investigation of new medicines in the paediatric population. An agreed PIP is a prerequisite for filing for marketing authorization for any new medicines in Europe. Consequently, EMA required this PIP prior to Arctic Bioscience initiating the Phase IIb study for HRO350 in adults. The PIP is therefore a critical component of the regulatory drug development journey for HRO350.

Not all medicines being developed for adults are deemed suitable for use in children. Based on the data submitted by Arctic Bioscience, the PDCO notes no concerns on potential long term safety/efficacy issues in relation to paediatric use.

Christer Valderhaug, CEO commented:

"We are now preparing for the Phase IIb study initiation in 2022 and a paediatric investigational plan is necessary for us to move forward with our clinical development program. I am very pleased that the team has proven its capability to reach such a significant milestone. In addition to paving the way forward for trials of HRO350 in adults, it also expands the future potential of HRO350 for use in children. Thus, showing Arctic Bioscience's dedication to investigate the efficacy of HRO350 in the treatment of paediatric psoriasis."

Onset of psoriasis can occur during childhood or adulthood

Psoriasis is a chronic, non-communicable, inflammatory skin disorder with no clear cause or cure. It is estimated that psoriasis affects 2-3 % of the population worldwide and can have a profound impact on patients quality of life (Yeung 2013; World Health Organization 2016). Psoriasis in children and adults manifests similar physical symptoms, genetics, cytokine profiles and is associated with the same comorbidities. The onset of psoriasis can occur during childhood or adulthood, with one-third of the cases beginning in children under the age of 18. Paediatric psoriasis is a common disease, affecting approximately 1% of children (Menter 2020; Augustin 2010; Bronckers 2015; Queiro 2014).

Treatment options for children with psoriasis are severely limited

Currently there are few approved treatment options for psoriasis in children, mostly limited to biologic medicines that are only approved for moderate and severe disease. Although topical corticosteroids are commonly used, but their use should be limited as corticosteroids are associated with adverse events in children.

HRO350 is an investigational medicinal product being developed for the treatment of mild-to-moderate psoriasis. The drug development program for HRO350 is planned to include a large phase IIb clinical trial and a following phase III trial, in adults with mild-to-moderate psoriasis.

Arctic Biosciences paediatric investigational plan for HRO350 is intended for children less than 18 years of age with paediatric psoriasis. The plan includes development of age appropriate pharmaceutical forms suitable for use in children. A deferral for completion of the paediatric investigational plan is granted until after the planned completion of the development program for HRO350 for adults.

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Christer Valderhaug

CEO Arctic Bioscience

Phone: +47920 84 601

About Arctic Bioscience[RG1]Arctic Bioscience is a biotech company developing and commercializing nutraceutical and pharmaceutical products based on unique bioactive marine compounds from herring roe.

The company is developing HRO350 - a novel investigational drug candidate based on herring roe. HRO350 is being developed for treatment of patients with mild-to-moderate psoriasis. This is a large patient group in need of new effective medicines with beneficial safety profile.

Herring roe contains lipids that are essential in maintaining cell membranes and omega -3 fatty acids that contribute to the normal functioning of brain, heart, and vision. Nutraceuticals from Arctic Bioscience are sold globally as bulk ingredients as well as finished goods under the ROMEGA brand. The strategy is to switch sales from bulk to finished goods and focus markets are USA and China.

Arctic Bioscience is led by a team of highly competent people with experience in developing marine oils and experience from global pharmaceutical companies.

[RG1]Please note we made some changes in the boiler text. Is this acceptable? We should regardless update our existing boiler text.

https://news.cision.com/arctic-bioscience-as/r/arctic-bioscience-as-receives-positive-opinion-on-paediatric-investigational-plan-from-the-european-,c3524844

(c) 2022 Cision. All rights reserved., source Press Releases - English

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Arctic Bioscience AS receives positive opinion on Paediatric Investigational Plan from the European Medicines Agency - Marketscreener.com

A recent comprehensive study entitled Global Psoriasis Drugs Market presents a comprehensive evaluation of the market. The report analyzes the market status in terms of market size forecasts and estimates and growth rates. The report performs in-depth estimates via in-depth insights, understanding market evolution by tracking historical developments and analyzing the present scenario and future projections. Each research report serves as a repository of analysis and information for every side of the market. It focuses on insights into the market size, trends, share, growth, and drivers analysis. Then the report covers every aspect associated with the existing trends, profitability position, regional valuation, and business expansion plans of key players in the global Psoriasis Drugs market. The market report also covers important players of the market recognized through their product offerings and market share.

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Global Psoriasis Drugs Market Market 2022 Industry Size, Trends, Growing Research, Advancements Technological, Growth Projections and Forecast 2028 ...

Global Systemic Psoriasis Therapeutics Market from 2021 to 2027 is the title of a major market research study performed by MarketQuest.biz that examines market growth prospects and opportunities. The research includes an industry summary, requirements, product description, and goals, as well as an industry analysis. The major goal of the research is to give broad information about the industrys competitors, market trends, market potential, growth rate, and other important statistics.

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Global Systemic Psoriasis Therapeutics Market 2021 Industry Statistics, Major Manufacturers Performance and Future Outlook by 2027 The Bollywood...

Transcript:

Peter A. Lio, MD: Hello, and welcome to this HCPLive Peer Exchange titled Management of Type 2 Inflammation in Atopic Dermatitis. Im Peter Lio from Medical Dermatology Associates of Chicago [Illinois]. Joining me in this discussion are my colleagues Dr Neal Jain, a pediatric allergist in Gilbert, Arizona; Dr Mark Serota, a dermatologist and an allergist at MD Integrations in Denver, Colorado; and Dr Matt Feldman, an allergist from Dallas, Texas.

Our discussion will focus on treatment selection and utilization of recently approved treatments, including interleukin pathway inhibitors for the treatment of type 2 inflammation in atopic dermatitis.

Were also going to share our thoughts on the newer mechanisms of action being studied and some of the unmet needs for patients with moderate to severe atopic dermatitis as well. Welcome, everyone. Lets get started.

Lets begin by thinking about atopic dermatitisspecifically the kind of inflammation were seeing herethis type 2 inflammation. When we think about this, we understand that broadly speaking, the immune system has 2 major arms: type 1 inflammation and type 2 inflammation. We know type 2 is the type were talking about with allergic diseases, IgE-mediated things like food allergy, asthma, allergic rhinitis, and of course atopic dermatitis. Other diseaseslike psoriasis, probably rheumatoid arthritis to some degreeseem to be on the other side of the immune system. Although we understand that its probably a little more complicated than this.

Its not quite a teeter-totter. Theres some overlap. We know, for example, in atopic dermatitis, as we get to later stages, we see the role of Th22 and maybe even Th1. We also know, fascinatingly, that its probably not the same for everybody. This is not 1 disease. There are multiple phenotypes, genotypes, and biomarkers that are part of this, and were just in the infancy of understanding this. For different groups of patients and even different ages, pediatric disease vs adult disease, there probably are very distinctive phenotypes that were just learning about.

That being said, we understand that this is generally a Th2-mediated disease, and weve been able to identify some of the cytokines that are associated with the early phases in particular and some of the moderate phases of atopic dermatitis, like IL-4, IL-5, IL-13, and IL-31, the master itch cytokine, with thymic stromal lymphopoietin being released from keratinocytes, in particular. All these guys driving inflammation, driving itch, and also damaging the skin barrier.

This brings us to that pathophysiology of thinking about it, but what does it mean for us in terms of managing the disease when we think about this from a population standpoint? Do you feel that there are populations that seem to have certain features or subtypes? Dr Jain, maybe you could talk to us a little about that to start us off.

Neal Jain, MD: You gave a great overview, and you hit the nail on the head: its different in different individuals. There are certainly distinct phenotypes that we see and different patterns of inflammation.

Sometimes the different patterns of inflammation can affect the way that skin might appear in atopic dermatitis; for example, patients with skin of color with different racial and ethnic backgrounds. Those are things we have to keep in mind.

Fundamentally, as you said, this is type 2 inflammatory disease. Although there are other types of inflammation that often can come into playchronicity, racial or ethnic phenotypethat background type 2 inflammatory pathway is activated even in those who have different phenotypes, whether you have whats historically been known as an extrinsic vs intrinsic phenotype. Type 2 inflammation is fundamentally important in the disease process.

Peter A. Lio, MD: I love it. Dr Serota, when youre seeing a patient, are there certain characteristics that make you think, This ones going to be more difficult? Or that its going to have a higher likelihood to persist or recur?

Marc Serota, MD: That breaks down to 2 things. The first part is making sure you have the diagnosis right. When I hear that a patient has failed typical therapies, either topicals or systemics, the first thing you always have to do is look at yourself in the mirror and ask, Do I have the diagnosis right? Is this atopic dermatitis, or is it 1 of the mimics of atopic dermatitis?

Assuming you do have the diagnosis right, certain factors will prompt you to the idea that the patient may be more difficult to treat. One would be if they failed prior therapies. The second would be if they have a large body surface area or more severe disease. The third would be if they have other atopic comorbiditiesconcomitant asthma or allergiesor triggers that theyre living with that they cant avoid. Those are some of the things that might prompt you to say this might be a more difficult patient.

The first step is identifying that you have the diagnosis right. The second is to identify some of the historical points and examination points that might make you say it would be a more challenging patient: increased body surface area, more severe disease, other atopic comorbidities, and other external factors that might make it more challenging for you to get that patients atopic dermatitis under control.

Peter A. Lio, MD: Thank you. Dr Feldman, when you see patients presenting with multiple allergic comorbidities, do you feel like they usually fuel one another, that theyre more challenging patients if they have atopic dermatitis plus food allergy plus asthma or allergic rhinitis? Or do you feel like you can see even isolated allergic diseases that can be just as bad or even worse?

Matt Feldman, MD: Thats a great question. Its patient dependent, and part of it is also if were focusing on the pediatric patient whos following along the atopic march. On the 1 hand, its helpful to educate the family about that atopic march and how all these other comorbidities at times can feed one another. The asthma flares as theyre playing outside at summer camp, walking through the grassy fields, etc. Theyre sneezing, wheezing, and itching all at once.

That can be a helpful way to educate the family about the underlying pathophysiology of type 2 inflammation that theyre seeing living and breathing biomarkers in front of them. At times it can, no pun intended, get us in the weeds a little. Sometimes I have familieskids and adultsthat will come in thinking that the food is the driver of their atopic dermatitis as opposed to maybe the dog in the home that they have a specific IgE of 95 IU/mL too. Sorting through those different atopic comorbidities in the individual patient is important on an individual basis because all our patients are so different and heterogeneous.

Neal Jain, MD: You made some good points, Peter, as did Mark and Dr Feldman. One thing we need to inform our patients about when we see young kids and even adults is the chronic nature of this disease. Were learning more about these different phenotypes. I agree entirely with Dr Serota. When its confusing and you see these patients with severe disease, especially with skin of color, which may have a more psoriasiform-appearing dermatitis, [we have to] look for those atopic comorbidities can help us identify that this is atopic dermatitis. [That will] help ground us in the fact that that is whats going on.

There have been some interesting studies published even recently about phenotypes of atopic dermatitis. To the point Dr Feldman was making, we know that comorbid food allergy may seem to define a population of patients with atopic dermatitis that tends to be a little more severe. We see increased levels of transepidermal water loss and decreased filaggrin expression. Its not that the food allergy is caused by the atopic dermatitis, but it helps us define a subtype of atopic dermatitis that may be more severe.

Marc Serota, MD: For patients with atopic dermatitis, its very important to assess their comorbidities for a few reasons. One [is that its] sometimes difficult to diagnose someone with atopic dermatitis as opposed to a mimic, and you can use the fact that around 50% of your patients with atopic dermatitis will have another atopic condition, like asthma, like allergic rhinitis, like food allergies. If you identify that they have 1 of those comorbidities, the first thing it can do is help you make the diagnosis of atopic dermatitis. It adds to your clinical history and can help bolster the argument that you do have a patient with atopic dermatitis.

The second reason that its important to assess for those is just like psoriatic arthritis and our patients with psoriasis, psoriatic arthritis is the game-over scenario of psoriasis. Its nice that we clear their skin, but if their joints are being affected and we dont address that, then potentially they can have morbidity associated with that undiagnosed problem. The same is true in the atopic world. We want to assess patients specifically for asthma because were not going to fix that by just giving them a topical steroid cream, for example. If they have uncontrolled asthma, 1, that might tip us into using a systemic we might not otherwise have, and 2, we have treatments that can treat both conditions simultaneously.

Its very important to assess for comorbidities, even if your specialty isnt allergy asthma immunology. If youre a dermatologist, just as we assess patients for psoriatic arthritis for psoriasis, its also important that we assess patients for uncontrolled asthma. I ask a few screening questions. How often are you using your albuterol? If its every day, youre not under good control. Are you waking up at night coughing and wheezing? Have you been to the ED [emergency department] for asthma? Have you been hospitalized for asthma? Have you ever been intubated for asthma? Those are red flags that their asthma may be poorly controlled. Youll want to factor that in when youre considering what treatment youre going to choose to treat their atopic dermatitis as well.

Transcript edited for clarity.

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An Overview of Type 2 Inflammation and Atopic Dermatitis - MD Magazine