Core Viewpoint - InnoCare Pharma has initiated a global Phase II clinical trial for its TYK2 inhibitor, Soficitinib, targeting prurigo nodularis in China, marking a significant step in its development pipeline for autoimmune diseases [1][5]. Company Overview - InnoCare Pharma is a biopharmaceutical company focused on developing treatments for cancer and autoimmune diseases, with a commitment to addressing unmet medical needs both in China and globally [6]. Product Development - Soficitinib is a selective TYK2 inhibitor aimed at treating various T-cell related autoimmune disorders, including prurigo nodularis, atopic dermatitis, and vitiligo, among others [2][5]. - The drug works by blocking cytokine signaling pathways associated with itching and inflammation, thereby alleviating symptoms of prurigo nodularis [3]. Market Potential - There are approximately 10 million patients suffering from prurigo nodularis globally, with the market for this condition valued at US$2 billion in 2024 and projected to grow to US$3 billion by 2034 [4].

Summary of Alumis Conference Call Company Overview - **Company**: Alumis (NasdaqGS:ALMS) - **Focus**: Development of TYK2 inhibitors for autoimmune diseases, specifically psoriasis and lupus [2][4] Key Points Product Pipeline - **Envudeucitinib**: - Phase 3 trial for psoriasis nearing completion, with data readout expected in Q1 2026 [4] - Phase 2b trial for systemic lupus erythematosus (SLE) planned for Q3 2026 [4] - **Second TYK2 Inhibitor**: - A brain-penetrant TYK2 inhibitor entering Phase 2 for multiple sclerosis (MS) in H1 2026 [3] - **Lonigutamab**: - Acquired through merger with Acelyrin, currently in Phase 2 [3] Market Opportunity - **Psoriasis**: - Significant unmet need for high-efficacy oral drugs; over 75% of patients prefer oral medications over injectables [5][6] - Current leading drugs are Otesla and methotrexate, indicating a gap for better-tolerated options [6] - **Lupus**: - No approved oral therapies currently available; potential for Envudeucitinib to fill this gap [14] - Anifrolumab, a competitor, is projected to reach $1 billion in sales, highlighting market potential [14] Clinical Data and Efficacy - **Psoriasis Data**: - Phase 2 results show PASI 75 efficacy between 80-90%, PASI 90 between 60-70%, and PASI 100 between 35-45% [11] - Strong impact on itch reduction, with over 70% of patients experiencing significant improvement [12] - **Safety Profile**: - Data from over 2,000 patients shows no significant safety signals, critical for market acceptance [7] Competitive Landscape - **TYK2 Inhibitors**: - Conviction that TYK2 can be effective across various immune indications based on early data [4][20] - Comparison with other TYK2 inhibitors indicates a more favorable PK/PD profile for Envudeucitinib [21][23] - **Market Positioning**: - Emphasis on the simplicity of oral administration as a competitive advantage [9][30] Strategic Considerations - **Partnership Strategy**: - Plans to partner Envudeucitinib to maximize asset value, with flexibility to wait for additional data before finalizing partnerships [32][33] - **Cash Position**: - Over $480 million in cash, providing runway into 2027 to support ongoing trials [37] Future Outlook - **2026 Expectations**: - Anticipation of multiple transformational events, including data readouts for psoriasis and lupus [4][18] - **Long-term Vision**: - Continued development of A-005 and Lonigutamab as part of Alumis's future pipeline [34] Additional Insights - **Genomic Data**: - Strong correlation between TYK2 inhibition and autoimmune disease prevention, suggesting a robust scientific foundation for the drug's efficacy [10][20] - **Enrollment Success**: - Rapid enrollment in lupus trials, indicating strong investigator interest and confidence in the drug's profile [30][31]

Summary of Alumis Conference Call Company Overview - **Company**: Alumis - **Lead Asset**: Envutuzitinib, a TYK2 inhibitor - **Age**: Approximately 4.5 years old, approaching 5 years Key Points and Arguments Product Development and Pipeline - **Envutuzitinib** is the lead molecule targeting autoimmune diseases, particularly psoriasis and lupus [2][3] - The company has three clinical assets, all beyond phase one, with the lead indication being psoriasis [3] - **Psoriasis Program**: Expected data readout in early Q1 next year, with confidence in competitive positioning based on preclinical and phase two data [3][4] - **Lupus Program**: Phase 2b trial designed as a pivotal trial, with data expected in Q3 next year [4] Competitive Landscape - Anticipation of multiple readouts in the TYK2 space from competitors next year [6] - The company plans to partner Envutuzitinib, which could influence overall business strategy [6] Clinical Trial Insights - **Phase Two Data**: Envutuzitinib showed a clear dose response, with the ability to dose-increase without reduction, distinguishing it from competitors [9][10] - **Enrollment Success**: Rapid enrollment attributed to the simplicity and safety of the drug, leading to over-enrollment in trials [12][13] - **Demographics**: Phase two primarily involved U.S. and Canadian patients, with expectations for more diverse demographics in phase three [15][16] Market Expectations - Aiming for PASI 90 response rates between 60-70% in phase three, which would position the product competitively [23][24] - Potential NDA filing could occur next year, pending data collection on durability and maintenance [25] Lupus Opportunity - The LUMA study involves over 400 patients, with data expected in Q3 next year [29] - The primary endpoint is BICLA, with secondary endpoints including SRI-4 [31] Future Indications - If lupus trial is successful, it may open opportunities in other interferon-driven diseases [35] - Interest in exploring indications for inflammatory bowel disease (IBD) based on competitor trials [35] Other Assets - **A-005**: A brain-penetrant molecule, with phase one completed and plans to start phase two in MS in the first half of next year [36][37] - **Lonigutamab**: Under evaluation for potential development, with ongoing assessments of competitive landscape [40] Financial Health - The company reported a strong balance sheet with over $480 million at the end of Q2, providing a cash runway into 2027 [41]

Core Viewpoint - Galapagos NV is set to present new in vitro pharmacological data for its selective TYK2 inhibitor, GLPG3667, at the ACR Convergence 2025, highlighting its differentiation from other TYK2 inhibitors in clinical dose regimens [1][2]. Group 1: Study Overview - GLPG3667 is currently being evaluated in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM) [5]. - The GALACELA study is a randomized, double-blind, placebo-controlled trial assessing GLPG3667's efficacy and safety in adults with active SLE over 48 weeks [6]. - The GALARISSO study is also a randomized, double-blind, placebo-controlled trial focusing on GLPG3667's efficacy and safety in adults with DM over 24 weeks [9]. Group 2: Key Findings - At the clinical dose of 150 mg once daily, GLPG3667 demonstrated comparable inhibition of the IFN-α and IL-23 pathways to currently approved TYK2 inhibitors, with a more pronounced inhibition of the IL-12 pathway [7]. - GLPG3667 showed no measurable inhibition of IL-10-mediated signaling at concentrations significantly above clinical levels, unlike other TYK2 inhibitors [7]. - The primary endpoint for the GALACELA study is the proportion of patients achieving the SLE responder index (SRI)-4 response at Week 32, with secondary endpoints including various lupus assessment scores [6][8].

Company Overview - Alumis is a precision immunology company that has been operational for approximately four years, focusing on a lead asset, a TYK2 inhibitor [2] - The lead asset, envudeucitinib, is being studied for psoriasis and lupus, with three clinical molecules and a research pipeline in development [2] Clinical Trials - The readout for psoriasis is expected in early Q1 of next year, with results from two Phase III trials, each involving around 850 patients [3] - The trials will assess both a 16-week endpoint against placebo and active drug, and a 24-week endpoint against active drug, positioning the company competitively in the market [3] - The readout for lupus is scheduled for the third quarter of next year, with the company currently in a Phase IIb trial for this indication [4]

Core Viewpoint - Alumis Inc. announced positive 52-week data from the open-label extension of its Phase 2 STRIDE clinical trial for ESK-001, indicating its potential as an effective oral therapy for moderate-to-severe plaque psoriasis [1][2][3] Group 1: Clinical Trial Results - Patients receiving 40 mg of ESK-001 twice daily showed sustained clinical responses at Week 52, with PASI 90 at 61.3% compared to 52.4% at Week 12, and PASI 100 at 38.8% compared to 26.8% [2] - At Week 52, 81.3% of patients reported improved control of itch (NRS≤4) and 61.3% reported enhanced quality of life (DLQI0/1) [2] - ESK-001 was well tolerated at Week 52, with safety profiles consistent with earlier data and no new safety findings reported [2][6] Group 2: Drug Profile and Mechanism - ESK-001 is a next-generation oral TYK2 inhibitor designed to correct immune dysregulation related to proinflammatory mediators such as IL-23, IL-17, and type 1 interferon [3][4] - The drug's selective targeting aims to maximize inhibition while minimizing off-target effects, positioning it as a potential best-in-class treatment for plaque psoriasis [4][6] Group 3: Ongoing and Future Studies - The Phase 3 ONWARD clinical program is currently underway, consisting of two parallel trials (ONWARD1 and ONWARD2) with approximately 840 patients each, comparing ESK-001 to placebo and apremilast [5][7] - Topline data from the ONWARD studies is expected in the first quarter of 2026, with ongoing patient enrollment for moderate-to-severe psoriasis [4][5] Group 4: Broader Development Strategy - Alumis is also developing a once-daily modified release formulation of ESK-001 and evaluating its application in systemic lupus erythematosus through the LUMUS Phase 2b trial [8] - The company leverages a precision data analytics platform to explore ESK-001's potential in other immune-mediated conditions, aiming to build a diverse pipeline of therapeutic options [9]