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AxisBiotix-Ps was described as delivering "tremendous results" for sufferers of the skin condition during a study conducted earlier this year

(, ) said the soft launch of its probiotic food supplement developed to help alleviate the effects of the skin condition psoriasis will take place on October 29, which is also World Psoriasis Day.

Initially, AxisBiotix-Ps will be marketed on a subscription basis and priced per sachet in the US at US$2.00, in the UK 1.50, and in Europe 1.80 and sold in boxes of 28.

Results from a study of self-identified psoriasis sufferers revealed the probiotic helped alleviate itchiness and irritability in around three-quarters of the cases.

The overall positive response from participants who identified as having psoriasis to AxisBiotix-Ps was tremendous, and we are very grateful for their continued interest and subsequent support, including their moving written and video testimonials, said chief executive Stuart Ashman.

"The soft launch aspect of the commercial strategy is a key element. Given the incurable and severe nature of psoriasis and its significant impact on people's lives, we have always said that we would initially release AxisBiotix-Ps on a controlled basis to ensure our distribution systems are robust. We want to ensure a continuous supply to our customers at all times."

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SkinBioTherapeutics to launch psoriasis targeting food supplement on October 29 - Proactive Investors UK

Interleukin (IL) are group of cytokines that are synthesized by lymphocytes, monocytes, macrophages, and other cells. They regulate cell growth, cell differentiation, and cell motility. Fifteen different types of interleukin are present in body. Interleukin inhibitors are immunosuppressive agents that inhibit the action of interleukins. Interleukin inhibitors are used in various conditions including asthma, ankylosing spondylitis, eczema, gout, arthritis (psoriatic and rheumatoid), psoriasis, and systematic sclerosis. Asthma is a chronic and long-term inflammatory disease of the lungs characterized by bronchospasm and airway obstruction. Ankylosing spondylitis is a type of arthritis that affects the spine. It affects about 0.1% to 0.5% of the adult population and can occur at any age. Eczema is a condition where patches of the skin become inflamed, itchy, red, cracked, and rough. It affects 31.6% of people in the U.S. Gout is a common and complex form of arthritis, characterized by severe joint pain. Psoriasis is non-contagious, chronic skin condition characterized by thickened and scaling skin. Systematic sclerosis is a connective tissue disease characterized by atrophy of the skin, vasomotor disturbance, and fibrosis.

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Increase in the prevalence of chronic inflammatory diseases such as arthritis, psoriasis, and asthma is a major factor fueling the global interleukin inhibitors market. In addition to this, increase in FDA approvals for novel drugs and therapies for chronic inflammatory disease treatment is further boosting the market. For instance, in 2017, Dupixent monoclonal antibody that targets the interleukin 4 became the first biologic approved for atopic dermatitis. Moreover, the presence of a strong product pipeline and rise in awareness among people regarding chronic inflammatory diseases and their treatment in emerging economies are projected to propel the market in the near future. However, side effects and high cost associated with biological therapy are likely to hamper the global interleukin inhibitors market in next few years.

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The global interleukin inhibitors market can be segmented based on disease condition, distribution channel, and region. Based on disease condition, the global interleukin inhibitors market can be categorized into asthma, ankylosing spondylitis, eczema, gout, arthritis (psoriatic and rheumatoid), psoriasis, systematic sclerosis, and others. In terms of distribution channel, the global market can be categorized into hospital pharmacies, online pharmacies, retail pharmacies, clinics, and research institutes.

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In terms of region, the global interleukin inhibitors market can be divided into North America, Europe, Latin America, Asia Pacific, and Middle East & Africa. North America is expected to hold a prominent share of the global market, due to rise in the patient pool suffering from psoriasis, arthritis, asthma, and other chronic inflammatory diseases. The presence of well-established drugs makers in North America is further expected to boost the market in the region. Additionally, according to the International Federation of Psoriasis Associations (IFPA), there are about 150,000 new cases of psoriasis every year in the U.S. According to a Centers for Disease Control and Prevention (CDC) report, in 2016, about 26,515 people lived with asthma in the U.S. Europe currently holds a strong position in the global interleukin inhibitors market. However, demand for interleukin inhibitors in the region is likely to decline due to intense competition among key players in the market in Europe. The market in Asia Pacific and Latin America is anticipated to expand at a rapid pace over the next few years due to rise in awareness regarding chronic inflammatory diseases, rapidly developing health care infrastructure, and increase in adoption of technology in these regions.

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Key players operating in the global Interleukin inhibitors market are Regeneron Pharmaceuticals, Inc. Novartis AG, Valeant Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Johnson & Johnson., Genentech, Inc. (Roche), Eli Lilly and Company, GlaxoSmithKline plc, Sanofi S.A., and AstraZeneca plc.

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Healthcare Facilities Management Market:

The demand within the healthcare facilities management market is increasing at a boisterous pace in recent times. The healthcare industry has gradually shifted from being an absolutist focused on medical procedures to a more diverse industry that prioritises patient safety, utility, and wellness. For this reason, healthcare facilities do not just focus on inducting the latest medical device or technology, going an extra mile to ensure state-of-the-art rooms, beds, and storage systems. Healthcare facilities management is a broad area that covers several services provided across hospitals wards, waiting areas, and other zones. In this context, the growth of the global healthcare facilities management market is expected to attract huge-scale revenues.

Prosthetics Market:

Since powered prosthetic devices require a great deal of electricity to function efficiently, researchers are developing innovative skin that stores electricity. For instance, researchers at the University of Glasgow have developed a combination electronic skin to generate and store electricity for prosthetic devices. Thus, manufacturers in the prosthetics market should collaborate with researchers to gain expertise in electrically powered prosthetics.

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Interleukin Inhibitors Market: Increase in the prevalence of chronic inflammatory diseases to drive the market - BioSpace

Earlier this year, MC2 Therapeutics entered a partnership with Almirall S.A. (ALM), a global biopharmaceutical company, granting Almirall exclusive European rights to commercialize Wynzora Cream (50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate).

Wynzora Cream (50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) is approved in Europe through a decentralized procedure for the treatment of mild to moderate psoriasis vulgaris in adults, including scalp psoriasis.

"We are excited to present new clinical research data to the European dermatology community at EADV 2021. Sharing of clinical data and continued development of our exciting pipeline are part of our commitment to address unmet needs for people living with chronic inflammatory diseases," says Dr. Morten Praestegaard, Ph.D., COO at MC2 Therapeutics.

About PsoriasisVulgaris

Psoriasis is a common, non-contagious, chronic skin disease with no clear cause or cure. The negative impact of psoriasis on people's lives can be immense as it affects the appearance of the skin with red, scaly plaques. Psoriasis affects people of all ages and in all countries. The reported prevalence of psoriasis in Europe is approximately 3% of the population1,2, making psoriasis a severe health problem with more than 100 million individuals affected worldwide.3The flares of psoriasis can be unpredictable and significant comorbidities are common, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease, and depression.3

About topical treatment of mild to moderate psoriasis vulgaris in adults

The combination of 50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate is a well-established topical treatment for mild to moderate psoriasis in adults. An aqueous cream formulation of calcipotriol and betamethasone dipropionate, based on the proprietary PAD Technology, allows for favorable delivery of the active ingredients to the target tissue. Wynzora Cream was also approved in the US by the FDA in July 2020 and launched in that market.4

About MC2 Therapeutics

MC2 Therapeutics is a privately held commercial-stage pharmaceutical company committed to building leadership in topicals and treatments for autoimmune and chronic inflammatory conditions. Our focus is to develop and advance best-in-class or first-in-class therapies by understanding the pathophysiology and researching novel compounds. Our goal is to minimize the burden of disease for people living with inflammatory or autoimmune diseases by addressing significant unmet needs. Using our patented PAD Technology we are introducing a new standard of topical treatment for the benefit of people living with psoriasis, the healthcare community, and society. Our innovative pipeline is comprised of drug candidates within CKD-ap (uremic pruritus), lichen sclerosis, Sjgren's syndrome dry eye, and atopic dermatitis.

For more information, please visit http://www.mc2therapeutics.com

References:

1Chandran, V., and S.P. Raychaudhuri. 2010. 'Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis', J. Autoimmune, 34: J314-J21

2Schafer, T. 2006. 'Epidemiology of psoriasis. Review and the German perspective', Dermatology, 212: 327-37

3WHO Global report on Psoriasis 2016

4USPI http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213422s000lbl.pdf

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MC2 Therapeutics' clinical research to be presented in four poster presentations at the European Academy of Dermatology and Venereology conference -...

Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to increase through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis

Deucravacitinib demonstrated efficacy regardless of baseline characteristics, including body weight, disease severity and previous treatment with biologic or non-biologic therapies

Patients on deucravacitinib demonstrated significantly greater improvements from baseline in psoriasis signs and symptoms compared with placebo and Otezla (apremilast) at Week 16, with the greatest improvement in symptoms reported for itch and skin tightness

No clinically meaningful changes from baseline levels in laboratory parameters compared to placebo or Otezla, consistent with data previously presented, with findings confirming no cumulative trends

PRINCETON, N.J., September 30, 2021--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that data from 19 company-sponsored scientific presentations are being shared at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress taking place September 29 October 2, 2021. The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the companys data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, as well as the emerging dermatology pipeline.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210930005581/en/

(Graphic: Bristol Myers Squibb)

Clinical research being presented at the meeting includes findings from new analyses of the global pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials in moderate to severe plaque psoriasis showing deucravacitinib demonstrated:

Durable efficacy through one year of treatment, with maximum response rates achieved by Week 24 [as measured by Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100, static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) and sPGA 0] and maintained through Week 52 (POETYK PSO-1). These data (Presentation #2857) are being presented today during the Late Breaking News Session from 3:45 4:45 p.m. CEST. Deucravacitinib also demonstrated durable efficacy in scalp psoriasis through 52 weeks of treatment (Poster Number: P1391).

Efficacy across a broad range of patient subgroups, with a consistently higher percentage of patients receiving deucravacitinib versus placebo and Otezla (apremilast) achieving PASI 75 and sPGA 0/1 response at Week 16 regardless of prior psoriasis treatment, baseline disease characteristics and baseline demographic factors. Data on the efficacy of deucravacitinib, regardless of prior psoriasis treatment (Presentation FC03.06), were featured as an oral presentation today from 2:30 3:30 p.m. CEST.

Significantly greater improvements from baseline of signs and symptoms of psoriasis compared with placebo and Otezla in all individual psoriasis symptom and sign scores at Week 16 as measured by the Psoriasis Symptoms and Signs Diary (PSSD). The greatest improvements in psoriasis symptoms were reported for itch and skin tightness, and the greatest improvements in psoriasis signs were reported for dryness, scaling and shedding or flaking (Poster Number: P1473).

As previously presented in the initial readout of the POETYK PSO-1 and POETYK PSO-2 results, deucravacitinib was well-tolerated and had a similar safety profile in both trials, with no new safety signals identified through 52 weeks of data. Laboratory data now shown from the trials for Weeks 0 to 52 (beyond what was initially presented for Weeks 0 to 16) confirmed no clinically meaningful changes from baseline levels observed in any laboratory parameters, including total cholesterol, creatine phosphokinase, neutrophils and platelets, which are four parameters that are known to change with Janus kinase (JAK) 1, 2 and 3 inhibition, and confirmed no cumulative trends (Poster Number: P1407).

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"In clinical practice, dermatologists treat a wide range of people living with moderate to severe plaque psoriasis, many of whom remain undertreated or even untreated and are in need of safe and well-tolerated oral therapies that provide durable efficacy," said Professor Richard B. Warren, Consultant Dermatologist, Salford Royal NHS Foundation Trust and Professor at The University of Manchester. "These new data show that deucravacitinib is efficacious, regardless of prior treatment and across patient subgroups, and that the strong response rates achieved in the pivotal studies at Week 16 improved to Week 24 and were maintained from Week 24 through one year. The results provide further evidence that deucravacitinib has the potential to become an important new oral treatment for those who require systemic therapy."

Additional data from Bristol Myers Squibbs dermatology pipeline being presented at the meeting include translational research assessing a potential therapy target for alopecia areata, for which there is currently no approved therapy; preclinical research on a novel sphingosine 1-phosphate receptor (S1PR) 1, 4 and 5 modulator (S1PR1,4,5) found to be highly efficacious in a mouse model of atopic dermatitis; and health economics and outcomes research on a predictive model from real-world data for identifying patients with psoriasis who are at risk for developing psoriatic arthritis.

"This robust body of research presented at EADVs 30th Anniversary Congress shows Bristol Myers Squibbs commitment to transforming medicine through science in diseases like moderate to severe plaque psoriasis and demonstrates the progress we are making as we build a differentiated portfolio of new treatments for serious dermatologic immune-mediated conditions," said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. "By focusing on addressing the pressing treatment gaps that continue to exist for those impacted by dermatologic diseases, our goal is to elevate standards of care and deliver novel, well-tolerated therapies that help patients achieve better disease control."

Bristol Myers Squibb-sponsored abstracts presented at EADVs 30th Anniversary Congress can be found below and accessed online here. Visit this page on BMS.com for more information on Bristol Myers Squibbs scientific approach and resources on dermatologic immune-mediated diseases.

Late Breaking Presentation

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: 52-Week Efficacy Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Richard WarrenPresentation Number: 2857Thursday, September 30, 3:45 4:45 p.m. CESTLate Breaking News Session

Clinical Presentations

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy Analysis by Prior Treatment in the Phase 3 POETYK PSO-1 and PSO-2 TrialsAuthor: Richard WarrenPresentation Number: FC03.06Thursday, September 30, 2:30 3:30 p.m. CESTOral presentation

Efficacy of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Musculoskeletal Manifestations of Active Psoriatic Arthritis in a Phase 2, Randomized, Double-Blind, Placebo-Controlled TrialAuthor: Philip MeasePoster Number: P0371Presentation Topic: Biologics, Immunotherapy, Targeted Therapy

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Scalp Psoriasis: Analysis of the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Andrew BlauveltPoster Number: P1391Presentation Topic: Psoriasis

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy by Prespecified Baseline Demographics in the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Melinda GooderhamPoster Number: P1393Presentation Topic: Psoriasis

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared with Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Integrated Laboratory Parameter Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Diamant ThaiPoster Number: P1407Presentation Topic: Psoriasis

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy Analysis by Baseline Disease Characteristics from the Phase 3 POETYK PSO-1 and PSO-2 TrialsAuthor: Joseph F. MerolaPoster Number: P1410Presentation Topic: Psoriasis

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared with Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Onset of Action in the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Neil KormanPoster Number: P1411Presentation Topic: Psoriasis

Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary Using Patient-Derived Outcomes from the Phase 3 POETYK PSO-1 and PSO-2 Trials of Deucravacitinib Versus Placebo and Apremilast in Moderate to Severe Plaque PsoriasisAuthor: Kim A. PappPoster Number: P1453Presentation Topic: Psoriasis

Preclinical Presentations

BMS-986166, a Novel S1PR1,4,5 Modulator, is Highly Efficacious in a Mouse Model of Atopic DermatitisAuthor: Jenny XiePoster Number: P0176Presentation Topic: Atopic Dermatitis/Eczema

Translational & Clinical Pharmacology Presentations

Selective Inhibition of Tyrosine Kinase 2 (TYK2) Protects Hair Follicles from Immune Privilege Collapse Induced by Interleukin (IL)-12 StimulationAuthor: Janin EdelkampPresentation Number: FC02.04Thursday September 30, 2021, 11:15 a.m. 12:15 p.m. CESTOral Presentation

Deucravacitinib, a Selective Tyrosine Kinase 2 (TYK2) Inhibitor: Overview of Clinical Pharmacology Including ADME, Food and pH Effects, Pharmacokinetics in Special Populations, and Drug-Drug InteractionsAuthor: Anjaneya ChimalakondaPoster Number: P1336Presentation Topic: Psoriasis

Health Economics and Outcomes Research (HEOR) Presentations

Development and Validation of a Claims-Based Algorithm to Identify Psoriasis SeverityAuthor: Joe ZhuoPoster Number: P0692Presentation Topic: Dermatology and Internal medicine, Including Skin Manifestations of Systemic Diseases

About Deucravacitinib

Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action and is the first and only selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferon (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Deucravacitinib achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Deucravacitinib selectively inhibits TYK2, unlike approved Janus kinase (JAK) 1, 2 and 3 inhibitors, at physiologically relevant concentrations. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.

Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435). Deucravacitinib is not approved for use in any country.

About the Phase 3 POETYK PSO-1 and POETYK PSO-2 Studies

PrOgram to Evaluate the efficacy and safety of deucravacitinib, a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) are global Phase 3 studies designed to evaluate the safety and efficacy of deucravacitinib compared to placebo and Otezla (apremilast) in patients with moderate to severe plaque psoriasis. Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients, were multi-center, randomized, double-blind trials that evaluated deucravacitinib (6 mg once daily) compared with placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 16 versus placebo. Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures evaluating deucravacitinib versus placebo and Otezla. Bristol Myers Squibb thanks the patients and investigators who participated in these clinical trials.

About Psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate to severe psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.

Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients Lives

Bristol Myers Squibb is inspired by a single vision transforming patients lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and multiple sclerosis. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission and perhaps even cures in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most the promise of living a better life.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Otezla (apremilast) is a registered trademark of Amgen Inc.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that deucravacitinib (BMS-986165) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibbs business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibbs Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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Contacts

Bristol Myers SquibbMedia Inquiries: media@bms.com

Investors: Tim Power609-252-7509Timothy.Power@bms.com

Nina Goworek908-673-9711Nina.Goworek@bms.com

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Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements...

This article was originally published here

Dermatol Ther (Heidelb). 2021 Sep 29. doi: 10.1007/s13555-021-00610-z. Online ahead of print.

ABSTRACT

More than 12 months have passed since the World Health Organization (WHO) declared Coronavirus Disease 19 (COVID-19), caused by the SARS-CoV2 virus, to be a pandemic on 11 March 2020. The entire world scientific community agrees that at this time vaccine is the most promising weapon to combat the infection and the severity of the disease. According to the document Draft landscape of COVID-19 candidate vaccines by WHO, 272 vaccines against SARS-CoV-2 virus are in development, although only four of these, produced by Pfizer-BioNTech (Pfizer, Inc. and BioNTech), Moderna, AstraZeneca, and Janssen companies, respectively, have been approved by European Medicines Agency and Italian Medicines Agency and subsequently distributed nationwide for use. These vaccines are the result of highly innovative procedures and are quite different from each other in terms of composition. Even clinicians in various medical fields may be unfamiliar with the effects of these vaccines. There is the strong emerging need for dermatologists to understand the crucial role of vaccines, with a focus on the need to vaccinate patients suffering from immune-mediated skin diseases, such as psoriasis, while taking the ongoing treatment into consideration regarding the timing of vaccination. Similarly, psoriasis patients aware of having an immune-mediated and inflammatory disease are increasingly asking the dermatologist information about the efficacy and safety of vaccines against SARS-CoV-2 virus. In this narrative review of the literature and critical analysis of the recommendations of the Italian Ministry of Health, we analyze the implications of the vaccination campaign on dermatological patients with psoriasis undergoing immunosuppressive treatment.

PMID:34586598 | DOI:10.1007/s13555-021-00610-z

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Vaccines Against SARS-CoV-2 in Psoriasis Patients on Immunosuppressive Therapy: Implications of Vaccination Nationwide Campaign on Clinical Practice...

NORTH CHICAGO, Ill., Sept. 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating risankizumab (SKYRIZI, 150 mg) in adults with active psoriatic arthritis for one year (52 weeks).1 These results were featured during the "Late Breaking News, Reviews and Updates" session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

KEEPsAKE-1 included adult patients with active psoriatic arthritis who responded inadequately to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). KEEPsAKE-2 included adult patients with active psoriatic arthritis who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).2-5 In the first phase of the studies (Period 1), patients were randomized to risankizumab or placebo until week 24.1 At week 24, the open label extension (Period 2) began, and all patients were treated with risankizumab.1,4,5

The new long-term data from the open-label extension period showed that 70 and 58 percent of patients initially treated with risankizumab achieved American College of Rheumatology 20 (ACR20) response in KEEPsAKE-1 and KEEPsAKE-2 respectively at one year, where patients with missing data were categorized as non-responders.1 Among patients initially treated with risankizumab, 43 percent in KEEPsAKE-1 and 32 percent in KEEPsAKE-2 achieved ACR50 response, and 26 percent in KEEPsAKE-1 and 17 percent in KEEPsAKE-2 achieved ACR70 response at one year.1

Additionally, at one year, 68 and 64 percent of patients initially treated with risankizumab and with a body surface area 3 percent at baseline achieved a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) in KEEPsAKE-1 and KEEPsAKE-2, respectively.1

"Millions of people still suffer daily with symptoms of psoriatic arthritis, driving us to advance treatment options for these patients," said Thomas Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "These new analyses at one year support the potential of risankizumab to maintain improvements across multiple manifestations of psoriatic arthritis."

In terms of improvement in physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]), patients initially randomized to risankizumab reported mean reduction (i.e., improvement) of 0.41 and 0.26 from baseline in HAQ-DI score for KEEPsAKE-1 and KEEPsAKE-2, respectively, at week 52.1

In addition, pooled results from KEEPsAKE-1 and KEEPsAKE-2 showed that 76 and 55 percent of patients achieved the resolution of dactylitis and resolution of enthesitis, respectively, at week 52.1

"Dactylitis is a common symptom in psoriatic arthritis that can cause severe swelling in the fingers and toes that result in everyday tasks becoming difficult," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute Copenhagen Denmark, associate professor, Lund Sweden, SUS University Hospital. "These results provide important insights on how both biologic-nave and experienced patients may benefit from treatment with risankizumab."

Both KEEPsAKE-1 and KEEPsAKE-2 demonstrated consistent long-term safety profiles with those shared at week 24, with no new safety findings observed from week 24 through week 52.1 Serious treatment-emergent adverse events (TEAE) occurred at 7.4 events/100 patient-years (E/100 PYs) and 9.4 E/100 PYs in KEEPsAKE-1 and KEEPsAKE-2, respectively.1 Rates of serious infections in KEEPsAKE-1 and KEEPsAKE-2 were 2.8 and 2.0 E/100 PYs, respectively.1 The rates of TEAEs leading to discontinuation of the study drug in KEEPsAKE-1 was 2.3 E/100 PYs and 1.6 E/100 PYs in KEEPsAKE-2.1 In KEEPsAKE-1, there were two deaths and both were not related to the study drug per investigator.1 There were no deaths reported in KEEPsAKE-2.1 In KEEPsAKE-2, three major adverse cardiac events (MACE) were reported, which were not related to the study drug per the investigator.1 No MACE were reported in KEEPsAKE-1.1

In January 2021, AbbVie announced positive top-line results from the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, showing that risankizumab (150 mg) achieved the primary endpoint of ACR20 response versus placebo during the 24-week double-blinded, placebo-controlled, parallel-group period (period 1).2,3

Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Use of risankizumab in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.6,7 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.6,7

About KEEPsAKE-1 and KEEPsAKE-22-5

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of risankizumab in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated risankizumab in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to risankizumab 150 mg or placebo followed by risankizumab 150 mg at week 24.

The primary endpoint for both studies was the achievement of ACR20 response at week 24 from the treatment with the study medication. Ranked secondary endpoints included change from baseline in HAQ-DI, as well as the achievement of PASI 90 and MDA at week 24. Other secondary endpoints included ACR50 and ACR70 (not controlled for multiplicity) at week 24. The studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of risankizumab in patients who have completed the placebo-controlled period.

More information on these trials can be found at http://www.clinicaltrials.gov(KEEPsAKE-1: NCT03675308;KEEPsAKE-2: NCT03671148).

About risankizumab (SKYRIZI)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8,9 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.8 In April 2019 SKYRIZI was approved by the European Commission for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The approved dose for SKYRIZI is 150 mg, administered by subcutaneous injection prefilled pen or prefilled syringe at week 0 and 4, and every 12 weeks thereafter.Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.10-12

Important EU Safety Information aboutSKYRIZI(risankizumab)9

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) atwww.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvieon Twitter,Facebook, Instagram, YouTubeand LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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References:

SOURCE AbbVie

https://abbvie.com/

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AbbVie Presents Late-Breaking Data on Risankizumab (SKYRIZI) in Psoriatic Arthritis at the 30th European Academy of Dermatology and Venereology (EADV)...