Category Archives: Psoriasis

Introduction to the FRONTIER 1 Trial

The FRONTIER 1 trial has recently revealed exciting news for patients suffering from moderate-to-severe plaque psoriasis. The study focused on the efficacy of the oral interleukin-23receptor antagonist peptide, JNJ-77242113. The results demonstrated a clear dose-response relationship, with the compound proving more effective than a placebo within a 16-week timeframe. This article will delve into the details of the FRONTIER 1 trial, its results, and what they mean for the future of psoriasis treatment.

JNJ-77242113 is the first and only targeted oral peptide that selectively blocks the IL-23 receptor. It has shown positive results in a Phase 2b study for moderate-to-severe plaque psoriasis, achieving the primary and all secondary endpoints. These endpoints included PASI 100 and IGA 0 responses of 40.5 percent and 45.2 percent respectively. The study showed a significant dose response on PASI 75 at Week 16 for adult patients who received JNJ-77242113 compared to patients treated with placebo. This makes it a promising candidate for future oral therapies that may offer an attractive and convenient treatment option for patients.

The drug JNJ 77242113 showed high response rates of 37 to 79 in moderate-to-severe plaque psoriasis in the FRONTIER 1 phase II trial. Patients treated with a placebo had a 9% response rate at 16 weeks. The most common adverse events were COVID 19 and nasopharyngitis. However, promising progress was shown in the treatment of moderate-to-severe psoriasis. The percentage of patients who had a PASI 90 response with JNJ 77242113 100 mg twice daily at week 16 was 60%. Despite these positive results, two occurrences of infection and a suicide attempt were reported as serious adverse events, indicating the necessity for larger trials to determine the cause of these events and the effectiveness of JNJ 77242113 in real-world settings.

The Phase II trial results of JNJ-77242113 have instigated the pivotal Phase 3 ICONIC clinical development program. This program aims to confirm the safety and efficacy of this promising new treatment in adult and adolescent patients. In comparison to injectable biologics, JNJ-77242113 showed a similar PASI 90 response rate of 60% at 16 weeks. This suggests that oral therapies could provide a viable alternative to injectables, offering greater flexibility, convenience, and effectiveness. Other oral therapies, like deucravacitinib, are also under development and show promise in revolutionizing psoriasis treatment.

The future of psoriasis treatment looks promising, particularly with the development of oral therapies such as JNJ-77242113. The results of the FRONTIER 1 trial offer a beacon of hope for patients dealing with moderate-to-severe plaque psoriasis. As we anticipate the results of the ICONIC clinical development program, the potential benefits of introducing an oral route of medication administration for patients with psoriasis is an exciting prospect. As research continues, the goal remains to provide safe, effective, and convenient treatment options for all psoriasis patients.

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Promising Results from the FRONTIER 1 Trial - An Exploration of JNJ-77242113 in the Treatment of Moderate-to ... - Medriva

Personal Experience with Psoriatic Arthritis

Maarten de Wit, diagnosed with Psoriatic Arthritis (PsA) during his teenage years, has firsthand experience of the difficulties involved in diagnosing PsA, especially in younger patients. PsA is a chronic inflammatory disease primarily characterized by plaque psoriasis but also has less common variants. It can lead to various comorbidities such as metabolic syndrome, cardiovascular disease, and mental health disorders. Despite the prevalence of PsA, affecting approximately 3% of the US population and causing an estimated healthcare expenditure of over 35 billion annually, its diagnosis is often complex and challenging.

To combat these challenges, the HIPPOCRATES project aims to improve PsA detection and prevent its onset. Similarly, the BIOMAP project seeks to understand and classify PsA and Atopic Dermatitis (AD) subtypes. Both projects utilize advanced molecular techniques in their pursuit of developing more effective treatments.

Atopic Dermatitis (AD) is another skin condition that requires attention, with numerous studies and articles discussing its treatment strategies, patient management, and potential therapeutic avenues. While conventional treatment methods have shown efficacy, managing patients with AD remains a challenge due to varying patient responses and the complex nature of the disease.

Genomic testing in dermatology is emerging as a promising approach to improve medical diagnoses and treatment. It explores the entire genome, including genetic and epigenetic factors, and has made significant advancements in analyzing skin microbiome and mutational analyses of inherited skin diseases. Genomic tests have emerged for various skin conditions like pigmented lesions, melanoma, and cutaneous squamous cell carcinoma and have also expanded into inflammatory skin diseases, offering insights through tape strips for AD and psoriasis.

Recent research has pointed towards a strong connection between gut health and dermatological diseases. The gut microbiome, consisting of over 1014 microorganisms, plays a significant role in human health. Dysbiosis, or imbalance in the gut microbiome, has been strongly associated with AD, psoriasis, acne, and alopecia areata. This has led to the examination of probiotics to correct gut microbiome dysbiosis as a potential treatment avenue for skin diseases.

While the diagnosis and treatment of PsA and AD continue to pose challenges, advancements in molecular techniques, genomic testing, and understanding the role of gut health in skin diseases are paving the way for more accurate diagnosis and effective treatment strategies. Initiatives like the HIPPOCRATES and BIOMAP projects are making strides in understanding these diseases at a molecular level, bringing hope for patients suffering from these conditions.

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Personal Experience with Psoriatic Arthritis and Atopic Dermatitis - Medriva

Stelara, a top-selling psoriasis drug by Johnson & Johnson (@JNJNews), has seen a consistent price increase since its introduction to the market. Since 2012, the drugs price has increased by at least 4.8% annually, leading to an overall price rise of 184%. This escalating cost has raised serious concerns about the drugs affordability for patients. The issue has been a hot topic of discussion among the Health, Education, Labor, and Pensions (HELP) Committee Democrats (@HELPCmteDems) and the GOP HELP Committee (@GOPHELP).

According to data from Simply Wall St, Johnson & Johnsons stock price, market cap, and recent performance are highlighted. The report also includes insights from equity analysts on the companys drug pipeline and revenue growth. Despite being a significant player in the pharmaceutical industry, JNJ has underperformed in the US Pharmaceuticals industry and the US Market over the past year. The Consumer Health segment of the company is also profiled on the site.

Despite the underperformance in certain sectors, Johnson & Johnson announced a strong finish to 2023. As reported on Investing.com, their fourth-quarter worldwide sales reached $21.4 billion, marking a 7.2% increase. The companys quarterly results just slightly exceeded Wall Street expectations.

The consistent price increase of Stelara has been a cause for concern among patients and healthcare advocates. Psoriasis is a chronic condition, and many patients require long-term medication such as Stelara to manage their symptoms. The significant increase in the drugs price puts a financial burden on patients, particularly those without comprehensive medical insurance.

The HELP Committee Democrats and the GOP HELP Committee have been engaged in discussions about the rising cost of Stelara. The committees are concerned about the impact of the price increase on patients and are exploring potential solutions to address this issue. While these discussions are ongoing, it is clear that the rising cost of Stelara is an issue that requires immediate attention.

The rising cost of medication is a pressing issue that affects patient accessibility to necessary treatments. For chronic conditions like psoriasis, the affordability of long-term medication is crucial. As discussions continue among various stakeholders, it is hoped that effective solutions will be found to ensure that patients can access and afford the medication they need.

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Rising Cost of Stelara: Impact on Patients and Johnson & Johnson's Market Performance - Medriva

Psoriatic Arthritis (PsA) Treatment Market

The global psoriatic arthritis (PsA) treatment market is poised for significant expansion, with Future Market Insights, a leading pharmaceutical entity, at the forefront of innovation. According to recent projections, the PsA treatment industry, valued at over US$ 10.3 billion in 2022, is expected to soar to US$ 15.6 billion by 2028, representing a robust compound annual growth rate (CAGR) of 7.1%.

Psoriatic arthritis, a chronic autoimmune disorder often accompanied by psoriasis, poses substantial challenges for patients and healthcare providers alike. However, recent advancements in medical research have paved the way for transformative treatments targeting the underlying immunological dysfunction and inflammation associated with PsA.

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Among these breakthroughs are small molecule targeted therapies, such as Janus kinase (JAK) inhibitors, which have demonstrated promising efficacy in managing PsA symptoms by interfering with specific inflammatory pathways. These medications offer patients alternative options for controlling their condition and improving their quality of life.

Future Market Insights remains committed to driving innovation in the field of PsA treatment, said Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.). We recognize the urgent need for effective therapies that address the complex nature of this debilitating condition. Through ongoing research and development efforts, we aim to provide healthcare professionals and patients with advanced treatment options that offer tangible clinical benefits.

The burgeoning demand for PsA treatments reflects both the growing prevalence of the condition and increasing awareness among patients and healthcare professionals. As the market continues to evolve, Future Market Insights is dedicated to leveraging its expertise and resources to deliver innovative solutions that address the unmet needs of individuals living with PsA.

Key Takeaways Psoriatic Arthritis (PsA) Treatment Market:

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Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 5000 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.

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Global Psoriatic Arthritis (PsA) Treatment Market to achieve a remarkable US$ 15.6 Billion by 2028, - PharmiWeb.com

Industry analyst GlobalData has highlighted research showing the potential of Janssens Tremfya (guselkumab) in the treatment of psoriasis.

Johnson & Johnsons (NYSE: JNJ) biotech subsidiary has recently released new data on the interleukin (IL)-23-targeting antibody in adults with moderate-to-severe plaque psoriasis (PsO).

A real-world data analysis and the results of J&Js Phase III VOYAGE 2 study suggest the product could

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Tremfya potential highlighted by industry analyst GlobalData - The Pharma Letter

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Patients with psoriasis are at an increased risk of both anxiety and depression, likely because of the stress of the disease.1

A team, led by Gloria-Beatrice Wintermann, Department of Psychotherapy and Psychosomatic Medicine, Faculty of Medicine, Technische Universitt Dresden,examined the impact of disease severity, health-related quality of life, and psychosocial stress on anxiety/depression for patients with moderate to severe psoriasis.

Mental comorbidities are common among patients with psoriasis, may additionally affect the therapy outcome. However, it is not currently whether the disease severity, psychosocial stress, or health-related quality of life are factors for the manifestation of anxiety or depression and vice versa in patients with psoriasis.

The interplay between these variables during the dermatological treatment of psoriasis remains to be elucidated in order to initiate appropriate psychological interventions and to identify patients at risk for comorbid anxiety/depression, the authors wrote.

In the prospective cohort study, the investigators examined patients with psoriasis during dermatological treatment before and about 3 months following the beginning of a new treatment episode. Most cases were by means of systemic therapy.

The investigators analyzed the data using Bivariate Larent Change Score Models and mediator analyses. They utilized patient-reported outcome measures to assess patients, including Hospital Anxiety and Depression Scale/HADS, Perceived Stress Scale/PSS, Childhood Trauma Questionnaire/CTQ, Dermatology Life Quality Index-DLQI, Body Surface Area-BSA at both study timepoints.

The study included patients with psoriasis with a median age of 53.7 years and a median BSA of 18.0. Patients with complete data on HADS and DLQI were included in the study.

The results show a higher anxiety/depression at the first assessment was linked to a lower improvement in psoriasis severity in the course of the dermatological treatment (BSA=0.50,P<0.001).

After analyzing subgroups of patients with psoriasis with low/high CTQ scores, anxiety/depression at the first time point had no impact on the change in psoriasis severity.

However, only by tendency, in CTQ subgroups, those with higher psoriasis severity was associated with a higher improvement in anxiety/depression at the second timepoint (low/high CTQ,HADS=0.16/0.15,P=0.08).

There was also an improvement in the health-related quality life that was positively associated with an improvement in anxiety/depression (Pearson'sr=0.49,P=0.02). with a reduction of acute psychosocial stress as the decisive factor, mediating the association (=0.20;t[2,60]=1.87;P=0.07, 95% confidence interval [CI], 0.01 to 0.41).

The results allude, that the initial severity of anxiety/depression may presumably have an impact on the treatment outcome in the total group, the authors wrote. In contrast, analyzing subgroups of patients with high/low childhood trauma, the impact of the initial disease severity on the course of anxiety/depression after a switch to a new dermatological treatment could not be conclusively ruled out.

One of the limitations of the is that the latent change score modelling had a small sample size.

A common aetiopathological mechanism for psoriasis and anxiety/depression might be assumed with impact of dermatological treatment on both, the authors wrote. The change in perceived stress seems to play an important role in the manifestation of anxiety/depression, substantiating the need for adequate stress management in patients with increased psychosocial stress during their dermatological treatment.

Wintermann, G., Bierling, A. L., Peters, E. M., Abraham, S., Beissert, S., & Weidner, K. (2023). Psychosocial stress affects the change of mental distress under dermatological treatmenta prospective cohort study in patients with psoriasis. Stress and Health. https://doi.org/10.1002/smi.3263

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Stress Leads to Increased Risk of Depression, Anxiety for Psoriasis ... - MD Magazine

In adults with active psoriatic arthritis (PsA) and prior inadequate responses to tumor necrosis factor inhibitors (TNFi-IR), guselkumab (Tremfya; Janssen) provided consistent and sustained improvements to minimal disease activity domains.

Janssen announced the results of its phase 3b COSMOS clinical trial evaluating the drugs safety and efficacy in a press release1. The study is 1 of several abstracts the company will be presenting at the 2023 Annual European Congress of Rheumatology (EULAR) meeting in Milan, Italy, this week.

Our continued research underscores Janssens commitment to not only provide therapeutic options for psoriatic disease, but also to better understand and support the pressing needs of the patients we serve, said Terence Rooney, MD, PhD, in the press release. Rooney is vice president, Rheumatology and Maternal-Fetal Immunology Disease area leader for Janssen Research & Development, LLC. Active psoriatic arthritis is a challenging, chronic disease, so these findings have important implications for patients and their providers as they work together to address the full spectrum of disease symptoms, including patient-reported outcomes, with the goal of achieving long-term relief.

Adults who had been diagnosed with active PsA and had a history of inadequate responses to 1 or 2 TNFi-IR (n=189) were eligible for participation in the trial. Researchers measured the efficacy of guselkumab in achieving sustained improvements across all MDA domains for a 48-week period.

Throughout the trial, researchers evaluated disease-specific, physician-reported domains and patient-driven domains, particularly at weeks 24 and 48. These included Health Assessment Questionnaire Disability Index (HAQ-DI), Leeds Enthesitis Index (LEI), patient global assessment (GA), patient pain, Psoriasis Areaand Severity Index (PASI), swollen joint count (SJC), and tender joint count (TJC).

Between week 24 and 48, all domains experienced improvement.

Week 24 Domains:

Week 48 Domains:

These results contradict those of a prior trial stating that a minority of patients with active PsA receiving biologic therapy are able to achieve sustained MDA, according to the press release.

Assessing patient-reported symptoms is a vital part of our research that helps us to address unmet needs and provide treatments that can improve outcomes, said Laura Coates, MD, PhD, in the press release. Coates is a senior clinical research fellow at the University of Oxford. These results advance our understanding of the psoriatic arthritis patient experience and will help healthcare professionals develop individualized treatment plans that can target debilitating symptoms and, ultimately, aim to improve quality of life for people living with psoriatic arthritis.

Reference

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Janssen Announces Positive Results From Guselkumab Psoriatic ... - Dermatology Times

Early intervention with secukinumab for patients with psoriasis may be helpful for those with the skin disease including those who are bio-nave, according to recent findings.1

There is evidence that the efficacy of secukinumab and the drugs survival may both be strong in those previously non-exposed to biologic treatments.2 That said, real-world research and case series on long-term efficacy and survival of the treatment in nave patients have been limited.

Consequently, this new multicenter study was done to analyze the long-term effectiveness and survival of the drug, and was authored by Francisco Javier Melgosa Ramos, MD, from the Department of Dermatology at the University Hospital Doctor Peset of Valencia in Spain.

Our objective and primary endpoint was to analyze the long-term efficacy and survival of secukinumab for the treatment of psoriasis in a retrospective, multicenter study performed in a Spanish cohort of psoriatic patients nave to biological therapies followed up to 8 years, Ramos and colleagues wrote. Secukinumab safety was evaluated as a secondary endpoint.

The investigators conducted the observational study across 8 Spanish hospitals to investigate the use of secukinumab in patients with psoriasis who had not previously received biological therapy. The team followed a daily practice cohort between January of 2014 and January of 2022, with a minimum follow-up period of 3 months and a maximum of 8 years.

The study participants initially received a weekly dose of 300 mg of secukinumab for 4 weeks, followed by monthly doses. However, some of the participants had their treatment regimen intensified or optimized based on the Physician Global Assessment (PGA) and disease control.

The study collected demographic data, information on previous nonbiological systemic therapies, and various study variables. The clinical response to the treatment was assessed by the research team using the Psoriasis Activity and Severity Index (PASI) throughout the period of their evaluation.

The investigators defined a complete response as reaching an absolute PASI score of 3 in plaque psoriasis or a PGA score of 1 in special localizations. The team also evaluated the safety of secukinumab and recorded any related side effects as a secondary endpoint.

Statistical analyses were done by utilizing the log-rank test to compare secukinumab survival time between different patient groups based on factors such as age, obesity, gender, and presence of psoriatic arthritis. Cox regression models were then utilized to explore the relationship between drug survival and patient characteristics.

The analyses also reported odds ratios (OR), with P < 0.05 being considered statistically significant. IBM SPSS v21.0 was used for the analyses.

The study ended up involving 128 individuals with moderate-to-severe cutaneous psoriasis who had not received biological therapies before. The investigators reported that around 92.2% of participants exhibited classical psoriasis plaques, while involvement in hard-to-treat areas was found to be less common.

It was reported that those included in the study were made up of 65 males and 63 females, with a mean age of 50.9 years. Approximately 47.2% of the participants were found to be obese.

The research team noted that psoriatic arthritis was detected in 18.8% of patients. The treatment response to secukinumab was evaluated at different follow-up periods, with a significant percentage of patients achieving low PASI scores.

The investigators also reported no occurrences of infections, malignancy, inflammatory bowel disease, or major adverse cardiovascular events associated with the treatments administration during the study period. No major differences were observed in terms of efficacy and survival rates based on factors such as BMI, gender, age, or the presence of psoriatic arthritis.

The research team noted that 86.6% - 100% of those ended up with a PASI score of 3 or lower, and 25% - 65.2% reached a PASI score of 0. The overall drug survival rate for secukinumab was also reported to be 81.9% over an average treatment exposure of 147.9 weeks.

To conclude, as observed in our cohort, the high long-term efficacy and survival of secukinumab in bio-nave patients and the low prevalence of arthritis and psoriasis-related comorbidities might suggest that managing severe psoriasis as a systemic disease, introducing advanced treatments early, could potentially modify the march of this disease, but further studies are needed, they wrote.

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Early Intervention with Secukinumab May Be Effective for Patients ... - MD Magazine

In an ex vivo study1, investigators found that vascular endothelial growth factor-a (VEGF-A) downregulates angiogenesis and blood vessel area in skin with psoriasis plaques. Furthermore, this downregulation is more abrupt among patients with psoriasis who have more severe disease or higher levels of VEGF-A.

Researchers sought to examine VEGF-A's impact on blood vessels, the epidermis, and immune cells in skin with and without psoriatic lesions, citing the known role of VEGF-A mediated angiogenesis in the pathogenesis of the disease. The study was the first to objectively examine the role of VEGF-A inhibition and its potential role as a treatment strategy for psoriasis. These data and findingslead researchers to believe that VEGF-A blocking therapy could be beneficial in patients with high levels of VEGF-A in their skin or plasma or with more severe psoriasis.

6 volunteers with psoriasis and 6 without the disease were recruited by researchers. Prospective participants with inflammatory arthropathy or who had used topical treatments (4 weeks prior) or systemic treatments (12 weeks prior) were excluded from participating.

Upon participant enrollment, researchers conducted skin sampling through skin punch biopsies taken from the same body site. In participants with psoriasis, researchers took 2 biopsies from regions of the skin with psoriasis plaques and 2 biopsies from skin without psoriatic lesions. Biopsies, once collected, were incubated and cultured.

Researchers also conducted examinations of histochemistry, immunofluorescence, and quantitative immunohistomorphometry. They also conducted a peripheral blood mononuclear cells culture, VEGF-A level quantification, DNA extraction, genotyping, and a statistical analysis.

In an organ culture, researchers found that the inhibition of VEGF-A with bevacizumab blocked free VEGF-A. At hours 12 and 48, skin incubated with 0.8 mg/mL of bevacizumab had undetectable levels of VEGF-A.

In skin samples with psoriasis plaques, VEGF-A blockade decreased the overall number of blood endothelial cells and blood vessel area. Additionally, VEGF-A inhibition did not significantly change the parameters of epidermal read-outs. Inhibition also had no significant changes on the number of CD4+ cells, CD8+T-cells, or tryptase+-mast cells in skin samples with psoriasis. Researchers were also unable to identify an association between genotype and patient response to anti-VEGF-A treatment.

While levels of VEGF-A plasma levels did not show significant differences between participants with and without psoriasis plaques, patients with more severe psoriasis tended to have higher levels of VEGF-A plasma levels than those with less severe disease.

According to researchers, potential study limitations included the limit number of volunteers and skin samples, as well as the studys ex vivo nature.

This pilot study provides proof-of-principle for the investigation of VEGF-A inhibition as an adjuvant management strategy to selectively target vascular pathology in psoriasis, study authors wrote. This approach could be especially beneficial for patients who have high levels of VEGF-A, offering an opportunity to personalize management and complement current anti-cytokine strategies and other standard-of-care psoriasis therapeutics.

Reference

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VEGF-A Inhibition Downregulates Blood Vessel Area in Psoriasis - Dermatology Times

Lynk Pharmaceuticals is running a phase 1b trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics of an ointment currently named LNK01004. It is targeted at people with mild to moderate plaque psoriasis.

Psoriasis is an immune-mediated, chronic, relapsing, inflammatory skin disease characterized by scaly erythematous or plaque lesions that can be local or widely distributed. Patients often require lifelong treatment to control symptoms and prevent complications from occurring or developing, thereby maintaining their quality of life.

Lynk say its ointment is a topical, skin-restricted soft pan JAK inhibitor intended for the treatment of psoriasis and other related conditions.

A JAK inhibitorinterferes with signals in the body that are thought to cause inflammation. This, in turn, reduces the inflammation that fuels diseases like eczema, psoriatic arthritis, and vitiligo. With less inflammation, the immune system calms down.

The drug is mainly distributed in the skin tissues but has minimal exposure in the blood system thereby avoiding potential safety issues caused by systemic immune suppression due to systemic exposure. As a representative third-generation JAK inhibitor, LNK01004, Lynk says, has the potential to be a first-in-class treatment.

Henry Wu, chief development officer of Lynk Pharmaceuticals, said: The completion of dosing the first cohort of patients with LNK01004 is an important milestone for the development of this compound.

LNK01004 has already shown good efficacy and safety in preclinical animal studies. Its phase I trial in healthy subject was completed earlier this year, and the results showed good safety profile. We look forward to LNK01004's good performance in patient trials.

Zhao-Kui (ZK) Wan, founder and CEO of Lynk Pharmaceuticals, added: As a third generation JAK inhibitor, LNK01004 can effectively inhibit psoriasis-related cytokine-induced JAK/STAT signalling pathways in skin tissues by topical application. Additionally, LNK01004 has the advantage of extremely low exposure in the blood system to potentially avoid safety concerns due to systemic exposure.

Wan said Lynk is committed to developing safer and more efficacious JAK inhibitors and emphasized that the differentiated products are the companys core competitive advantages.

He said: In addition to the highly selective JAK1 inhibitor LNK01001, we have also assembled a promising pipeline consisting of multiple third-generation, tissue-restricted soft pan JAK inhibitors in clinical trials including the GI-restricted LNK01003 for UC which is currently in phase 2a. We sincerely look forward to bringing safer, more efficacious and innovative treatment options to patients.

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Scratching the itch, Lynk Pharmaceuticals trialling ointment for ... - OutSourcing-Pharma.com