Latest news with #JAK
Yahoo
2 days ago
- Business
- Yahoo
Recludix Pharma Announces Development Candidate Nomination of First-in-Class Oral STAT6 Inhibitor for Inflammatory Diseases and Achievement of Significant Milestone Under Collaboration with Sanofi
--Completion of GLP toxicology studies associated with a $50 million payment to Recludix under the collaboration with Sanofi -- REX-8756 is a potent and selective oral STAT6 inhibitor that demonstrates complete pathway inhibition and is well tolerated in preclinical studies --Investigational New Drug (IND)-enabling activities ongoing to support IND submission later this year SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for inflammatory disease, today announced that the company has nominated a lead development candidate REX-8756, an oral, selective and reversible small molecule inhibitor of STAT6, and completed the GLP toxicology studies for the compound. Many allergic and inflammatory diseases -- such as asthma, COPD, and atopic dermatitis -- are caused by Type 2 inflammation, driven by the production of the cytokines Interleukin-4 (IL-4) and Interleukin-13 (IL-13). STAT6 is required for IL-4 and IL-13 signaling but is downstream in the disease pathway from other drug targets, and therefore, its inhibition has been shown in preclinical studies to be a more selective approach than Janus Kinase (JAK) family inhibitors, with potential for fewer side effects. 'There is significant opportunity to develop oral medicines with biologic-like activity and favorable safety profiles to provide alternatives to current therapies, such as JAK inhibitors which can impact viral immunity and hematopoiesis,' said Nancy Whiting, Pharm.D., president and chief executive officer of Recludix. 'At Recludix, we are driven to discover and develop best-in-class drug candidates that have the potential to become transformative medicines. We and our partner Sanofi are pleased to have reached this significant milestone in this important program and look forward to advancing REX-8756 to the clinic in the near term.' In preclinical studies, REX-8756 achieved complete and durable STAT6 inhibition, without degradation of the protein. STAT6 inhibition disrupted the production of IL-4/13 stimulated inflammatory biomarkers and has demonstrated potent efficacy in models of asthma, acute lung inflammation and dermatitis. REX-8756 inhibits STAT6 through its SH2 domain, which plays a key role in mediating protein-protein interactions and had been previously deemed undruggable. Through Recludix's proprietary platform that integrates new chemical approaches and technologies, the company has created massive custom SH2 domain-focused DNA-encoded libraries and proprietary selection assays, enabling the development of precision small molecule medicines against the SH2 domain of high-interest targets. 'We have discovered a number of oral STAT6 SH2 domain inhibitors that performed impressively in preclinical studies, speaking to the power of our platform,' said Ajay Nirula, M.D., Ph.D., executive vice president and head of research and development of Recludix. 'Following our recently presented preclinical data at the May 2025 American Thoracic Society Conference that further demonstrated the robust efficacy and differentiated safety profile of our STAT6 inhibitors, we are excited to advance REX-8756 as a potential first-in-class oral therapy for patients with immune-related inflammatory disease.' About Sanofi CollaborationRecludix is advancing STAT6 inhibitors from preclinical research and development until the start of Phase 2 clinical trials. Sanofi will assume worldwide clinical development and commercialization responsibilities thereafter. Sanofi has global rights to small molecule STAT6 inhibitors developed under the partnership. Recludix has the option to participate in U.S. profit/loss share, which includes the ability to share equally in the costs, profits and losses, and to certain co-promotion activities for the partnered product in the U.S. Recludix has now received $125 million in near-term payments. Additionally, Recludix may receive more than $1.2 billion in potential development, regulatory and sales milestones, as well as up to double-digit royalties on possible future product sales. About STAT6Signal transducer and activator of transcription (STAT) proteins are both signaling proteins and transcription factors that play a role in cell growth, differentiation and function. STAT6 is a key nodal transcription factor that selectively mediates downstream signaling of IL-4 and IL-13, dominant and central cytokines in the pathophysiology of Type 2 inflammatory diseases. A STAT6 inhibitor offers the potential for a novel first-in-class targeted oral therapy for patients in the treatment of Type 2 inflammatory diseases. About RecludixRecludix is a leader in developing platform approaches to discover potent and selective inhibitors of challenging protein targets. The company's management team includes industry veterans with a track record of success, including former leaders of Seagen, Blueprint Medicines, and Lilly. Recludix has developed a unique drug discovery platform that integrates custom generated DNA-encoded libraries, massively parallel determination of structure activity relationships, and a proprietary screening tool to ensure selectivity. The company is employing this approach first in the development of SH2 domain inhibitors. Recludix's most advanced program is focused on STAT6 (signal transducer and activator of transcription 6) where abnormal activation is found in inflammatory diseases, such as atopic dermatitis, asthma, rheumatoid arthritis and chronic spontaneous urticaria. The company has a strategic collaboration with Sanofi for the development and commercialization of a STAT6 inhibitor. Recludix is also advancing a potential first-in-class BTK SH2 domain inhibitor for B cell or mast cell-driven I&I diseases, as well as additional programs. Recludix was named a 2024 Fierce 15 biotech company. For more information, please visit the company's website at Recludix ContactsMatt Caldemeyer Chief Business Officermcaldemeyer@ Alexandra Santos asantos@ Aljanae Reynoldsareynolds@ in to access your portfolio
India Today
20-05-2025
- Health
- India Today
Scientists find common arthritis drugs could weaken immunity against Covid, flu
Drugs are meant to make us feel better, either by treating disease or easing symptoms. But sometimes, certain medicines could have unexpected side effects that could make things worse, especially during a virus outbreak.A team of scientists in Norway has now found that a commonly used group of anti-inflammatory drugs called Janus kinase inhibitors, or JAK inhibitors could actually make it easier for viruses like influenza and Covid-19 to spread inside the findings are published in NAR Molecular drugs are often used to treat chronic conditions such as rheumatoid arthritis and other autoimmune according to researchers at the Norwegian University of Science and Technology (NTNU), they may also reduce the body's natural defences against viruses."We have found a surprising and potentially serious side effect of these drugs. They can help viruses spread more easily in the body,' said Professor Denis Kainov from NTNU's Department of Clinical and Molecular simple terms, the drugs seem to weaken an important signalling process in the immune system, one that helps protect healthy cells from being this pathway is blocked, the body's ability to detect and fight viruses is research team tested the effects of JAK inhibitors on human cells taken from the lungs, eyes, and also studied mini-organs grown in the lab and used advanced gene analysis found that a drug like baricitinib, commonly used for arthritis, slows down the activity of certain genes that kick into action when a virus genes act like a security system in the body. When it's down, viruses like SARS-CoV-2 (which causes Covid) adenovirus, and influenza A can spread Ravlo, the study's lead author, said the findings show that while JAK inhibitors are useful in managing inflammation, they could carry hidden risks during viral infections, especially for people with a weak immune system.'Doctors should be careful when prescribing these drugs, particularly during times when viruses like Covid-19 or flu are circulating widely,' Ravlo the researchers also said that in controlled environments, such as during vaccine development or drug screening, this side effect might actually be instance, by making it easier to test how well a new antiviral treatment scientists are now calling for more research into how these drugs work in real-world conditions.
Yahoo
16-05-2025
- Health
- Yahoo
Alopecia Areata: Market Trends, Regulatory Framework, Clinical Trial Analysis, Epidemiology Analysis, Market Dynamics, Competitive Landscape 2025-2035
Includes Detailed Profiles of Industry Giants Eli Lilly & Company, Pfizer, Sun Pharmaceutical Industries, Arcutis Biotherapeutics, Bristol-Myers Squibb, AbbVie, Regeneron Pharmaceuticals, and Aclaris Therapeutics Dublin, May 16, 2025 (GLOBE NEWSWIRE) -- The "Alopecia Areata Market - A Global and Regional Analysis: Focus on Drug Class and Region - Analysis and Forecast, 2025-2035" report has been added to global market for alopecia areata treatments has experienced substantial growth due to increasing awareness, advancements in medical research, and the introduction of novel therapeutic options. One of the notable examples of current treatments is JAK inhibitors like Ritlecitinib (brand name Litfulo), which received approval by the U.S. FDA for the treatment of alopecia areata in adolescents. This approval marked a significant advancement, given the earlier limited treatment options available for those suffering from this of the key drivers of the alopecia areata market is increasing prevalence of alopecia areata. Alopecia areata affects around 2% of the global population, and its prevalence has been steadily increasing. Environmental factors like stress, pollution, and lifestyle changes are contributing to this rise. The increasing incidence of autoimmune disorders overall also means more individuals are prone to developing alopecia areata. For instance, data from the American Academy of Dermatology estimates that approximately 6.8 million people in the U.S. alone have been affected by some form of traditional treatments like corticosteroids and topical immunotherapy have been somewhat effective, but the market is now being transformed by novel therapies such as JAK inhibitors, which block the pathways involved in the autoimmune attack on hair follicles. One such breakthrough is Dupixent (dupilumab), a monoclonal antibody used to treat moderate-to-severe atopic dermatitis, which has also shown promise for patients with alopecia areata. The approval of Ritlecitinib for alopecia in adolescents in 2023 is another example of how targeted therapies are creating new hope for those affected by the the market's growth, there are several challenges that hinder the wider adoption and accessibility of treatments. Advanced treatments such as biologics (e.g., Ritlecitinib and Dupixent) are often expensive, with some costing thousands of dollars per treatment cycle. This high cost of treatment limits access for many patients, particularly in developing regions where healthcare budgets are constrained. The cost barrier is significant in countries outside the U.S. and Europe, where access to biologics is more limited. The high cost of Dupixent, for example, is a point of concern for patients seeking affordable not all patients respond the same way to therapies. While JAK inhibitors have shown great promise for some individuals with alopecia areata, they may not work equally well for everyone. The variability in patient responses has led to the need for personalized treatment plans, which complicates the management of the condition and may increase healthcare addition, many regions, particularly in Africa, Asia, and Latin America, have limited access to newer treatments due to logistical, financial, and infrastructural barriers. Although global healthcare access is improving, the availability of cutting-edge treatments like JAK inhibitors remains a challenge in these underserved Segmentation Segmentation 1: by Drug Class Corticosteroids JAK (Janus Kinase) Inhibitors Others Segmentation 2: by Region North America Europe Asia-Pacific The alopecia areata market is experiencing several key emerging trends. One notable trend is the rise of personalized medicine, where treatment plans are tailored to an individual's genetic profile, disease progression, and response to therapy. Biotech companies are increasingly investing in genetic research and biomarkers to identify which patients will benefit most from specific treatments. Another trend is the growing demand for non-invasive therapies, such as topical corticosteroids, minoxidil solutions, and low-level laser therapies. These options are becoming more popular due to their reduced side effects and ease of use, offering more affordable and accessible solutions, especially in regions with limited access to biologics. As healthcare access expands globally, biologic therapies like JAK inhibitors are also gaining traction in emerging markets, with pharmaceutical companies working to improve accessibility through patient assistance programs and distribution conclusion, the Alopecia Areata (AA) market is positioned for continued growth, driven by advancements in biologic therapies, rising awareness, and increased healthcare access worldwide. Although challenges such as high treatment costs and variability in treatment response remain, the emergence of new therapies, personalized medicine, and the global expansion of access to effective treatments are poised to enhance the management of alopecia areata. The market is also benefiting from the growing emphasis on mental health and the psychological impact of hair loss, leading to more patient-centered care. As innovation continues, both large pharmaceutical companies and smaller biotech firms will drive competition and improve the quality of life for individuals living with alopecia Topics Covered1. Markets: Industry Outlook1.1 Introduction1.2 Market Trends1.3 Regulatory Framework1.4 Clinical Trial Analysis1.5 Epidemiology Analysis1.6 Market Dynamics1.6.1 Impact Analysis1.6.2 Market Drivers1.6.3 Market Challenges1.6.4 Market Opportunities2. Global Alopecia Areata Market, by Drug Class, ($Million), 2023-20352.1 Corticosteroids2.2 JAK (Janus Kinase) Inhibitors2.3 Others3. Global Alopecia Areata Market, by Region, ($Million), 2023-20353.1 North America3.1.1 Key Findings3.1.2 Market Dynamics3.1.3 Market Sizing and Forecast3.1.3.1 North America Alopecia Areata Market, by Country3.1.3.1.1 U.S.3.2 Europe3.2.1 Key Findings3.2.2 Market Dynamics3.2.3 Market Sizing and Forecast3.2.3.1 Europe Alopecia Areata Market, by Country3.2.3.1.1 Germany3.2.3.1.2 U.K.3.2.3.1.3 France3.2.3.1.4 Italy3.2.3.1.5 Spain3.3 Asia Pacific3.3.1 Key Findings3.3.2 Market Dynamics3.3.3 Market Sizing and Forecast3.3.3.1 Asia Pacific Alopecia Areata Market, by Country3.3.3.1.1 Japan4. Global Alopecia Areata Market: Competitive Landscape and Company Profiles4.1 Key Developments and Strategies4.1.1 Mergers and Acquisitions4.1.2 Synergistic Activities4.1.3 Business Expansions and Funding4.1.4 Product Launches and Approvals4.1.5 Other Activities4.2 Company Profiles4.2.1 Eli Lilly and Company4.2.1.1 Overview4.2.1.2 Top Products / Product Portfolio4.2.1.3 Target Customers/End-Users4.2.1.4 Key Personnel4.2.1.5 Analyst View4.2.2 Pfizer Inc.4.2.3 Sun Pharmaceutical Industries Ltd.4.2.4 Arcutis Biotherapeutics4.2.5 Bristol-Myers Squibb4.2.6 AbbVie4.2.7 Regeneron Pharmaceuticals4.2.8 Aclaris TherapeuticsFor more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
15-05-2025
- Health
- Medscape
Risks and Benefits of JAK Inhibitors for Vitiligo
In a meta-analysis, topical Janus kinase (JAK) inhibitors demonstrated promising but non-significant results for vitiligo, with patients administered JAK inhibitors having a higher likelihood of achieving a 75% improvement in facial repigmentation compared with those using a vehicle cream. However, single-arm trials and case reports indicated significant repigmentation with both oral and topical formulations. Oral JAK inhibitors were associated with potential adverse effects such as risks for immunosuppression and cardiovascular events. METHODOLOGY: Researchers conducted three meta-analyses of 19 studies to determine the safety and efficacy of JAK inhibitors in patients with vitiligo treated with oral or topical JAK inhibitors with or without conventional therapy. Three distinct analyses were conducted, with data analysed from randomised controlled trials (RCTs), four single-arm trials, and a novel cohort of JAK inhibitor–treated patients from case reports and case series. RCTs used topical ruxolitinib cream with placebo or vehicle cream as a comparator. Single-arm trials mostly used topical JAK inhibitors, whereas the novel cohort used oral JAK inhibitors. Primary efficacy outcomes were a 75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI75), mean percentage change in the VASI, and percentage of repigmentation in vitiligo lesions. TAKEAWAY: A meta-analysis of three RCTs showed that patients treated with topical JAK inhibitors were more likely to achieve F-VASI75 than those using vehicle cream (risk ratio [RR], 3.47; 95% CI, 0.98-12.22; P = .051), with no significant difference in adverse events between groups (RR, 1.27; 95% CI, 0.88-1.82). = .051), with no significant difference in adverse events between groups (RR, 1.27; 95% CI, 0.88-1.82). The pooled analysis of four single-arm trials demonstrated a mean percentage change in the VASI of 43.79% (95% CI, 0.71-0.93; P < .001). < .001). An analysis of the novel cohort revealed significantly increased repigmentation in patients treated with JAK inhibitors alone (48.7%; P = .0018) and in those treated with JAK inhibitors and narrowband ultraviolet B therapy (63.7%; P < .0001). = .0018) and in those treated with JAK inhibitors and narrowband ultraviolet B therapy (63.7%; < .0001). Topical JAK inhibitors generally exhibited a more favourable safety profile; however, oral JAK inhibitors were associated with risks for immunosuppression, cardiovascular events, and haematopoietic disorders. IN PRACTICE: "Although topical ruxolitinib demonstrated encouraging outcomes, its results in RCTs did not reach statistical significance. However, findings from single-arm trials and case studies revealed substantial repigmentation, particularly when oral JAKis [JAK inhibitors] were administered alongside other therapeutic interventions," the authors wrote. "Future RCTs are essential to evaluate long-term safety, refine optimal application protocols and establish standardised outcome measures for combination therapies, ultimately improving treatment strategies for vitiligo," they concluded. SOURCE: This study was led by Alzahra A. Mohammed, Department of Dermatology, Venereology and Dermatooncology, Faculty of Medicine, Semmelweis University in Budapest, Hungary. It was published online on May 07, 2025, in Dermatology and Therapy . LIMITATIONS: The analysis was constrained by the small number of RCTs available and challenges in data collection from case reports due to heterogeneity in outcome reporting. Clinically meaningful thresholds for improvement were inconsistently followed across case reports and single-arm trials, limiting their integration. Analysis of the novel cohort was further limited by potential reporting biases and small sample size, and follow-up durations of single-arm trials and the novel cohort were insufficient for a comprehensive analysis of adverse events or long-term safety concerns. DISCLOSURES: This study received funding through a grant from the EU Horizon 2020 research and innovation programme. The Hungarian Centre of Excellence for Molecular Medicine covered publication fees. The authors reported no relevant conflicts of interest.
Time of India
02-05-2025
- Health
- Time of India
New study finds tofacitinib effective and affordable for refractory atopic dermatitis
New Delhi: New Delhi: Tofacitinib , a Janus kinase (JAK) inhibitor drug, used either as a standalone treatment or alongside other drugs to address moderate to severe cases of rheumatoid arthritis and ankylosing spondylitis, demonstrates effectiveness in managing refractory atopic dermatitis (AD). Tired of too many ads? go ad free now This was revealed in a study published in the Indian Dermatology online journal. Atopic dermatitis (AD) presents as a long-term, recurring inflammatory disorder of the skin, and its characteristic itching significantly affects patients' daily living standards. The research was conducted at the department of dermatology, venereology and leprosy in Atal Bihari Vajpayee Institute of Medical Sciences and Research Institute and Dr Ram Manohar Lohia Hospital. The results established that people who previously showed no response to standard systemic treatments, including oral corticosteroids, cyclosporine and azathioprine, exhibited significant clinical improvement when administered tofacitinib exclusively. The progress was evaluated through decreased Scoring Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), and Numerical Rating Scale (NRS) measurements at 4-week and 8-week intervals. The principal investigator of the study and dermatologist at RML Hospital, professor Kabir Sardana, explained that their main goal was to evaluate how well tofacitinib worked and its side effects in patients with difficult-to-treat moderate-to-severe AD. Additionally, they aimed to analyse the treatment costs between tofacitinib and dupilumab (approved by the Central Drugs Standard Control Organisation, India) for moderate and severe AD cases. Tired of too many ads? go ad free now The research indicated an average disease duration of three years. Patients displayed moderate to severe pruritus, excoriations, erythema, oozing and crusting. All participants had previously experienced treatment failure or intolerance to systemic therapy; 50% of patients also had other atopic conditions and bronchial asthma. The researchers continued treatment with topical corticosteroids, moisturiser and topical calcineurin inhibitors alongside tofacitinib. Improvements were observed in pruritus, sleep quality, affected body surface area, erythema, excoriation, papulation/edema and lichenification, with notable severity score reductions at four weeks and eight weeks of therapy. Dr Sardana said that EASI 90 was attained by 66% of patients within 8 weeks, with one patient experiencing treatment failure. Patients achieved complete or near-complete disease resolution in an average of 6.1 weeks (ranging from 3-8 weeks). Disease recurrence was observed in 36.3% of patients. Adverse reactions occurred in 41.6% of patients, including herpes zoster, dyslipidemia, anaemia, impetigo, and thrombocytosis. The financial comparison revealed that dupilumab (a monoclonal antibody used to treat various allergic conditions, including atopic dermatitis, asthma, and nasal polyps) therapy costs 122 times more than tofacitinib treatment over an 8-week period.
