Core Insights - Alumis Inc. announced positive topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials for envudeucitinib, a selective oral TYK2 inhibitor for moderate-to-severe plaque psoriasis [2][3] - The trials met all primary and secondary endpoints with high statistical significance, showing superior skin clearance compared to placebo [3][4] - Approximately 65% of patients achieved PASI 90 and over 40% achieved PASI 100 at Week 24, indicating strong efficacy [4] Clinical Trial Results - Envudeucitinib achieved PASI 75 in 74% of patients and sPGA 0/1 in 59% of patients at Week 16, with rapid responses observed as early as Week 4 [3][4] - The drug demonstrated a favorable safety profile, with treatment-emergent adverse events primarily mild to moderate [5] - No new safety signals were reported, and common adverse events included headaches and upper respiratory infections [5] Future Plans - Alumis plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026 [2][6] - Additional results from the ONWARD trials will be presented at an upcoming medical meeting [6] - Topline data from the LUMUS Phase 2b trial in systemic lupus erythematosus is expected in Q3 2026 [7] Company Overview - Alumis is focused on developing next-generation targeted therapies for immune-mediated diseases, leveraging a proprietary data analytics platform [13] - The company is also developing other therapies, including A-005 for neuroinflammatory diseases and lonigutamab for thyroid eye disease [13] - The potential of envudeucitinib is highlighted as a transformative option for treating IL-23/IL-17-driven diseases [6][10]
Alumis’ Envudeucitinib Delivers Leading Skin Clearance Among Next-Generation Oral Plaque Psoriasis Therapies in Phase 3 Program