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]