Alumis' Envudeucitinib Achieves Significant Skin Clearance in Phase 3 Plaque Psoriasis Trials
Company Symbol: ALMS
Overview of Clinical Trial Results
Alumis Inc. (Nasdaq: ALMS), a biopharmaceutical company specializing in therapies for immune-mediated diseases, has announced promising results from its Phase 3 ONWARD1 and ONWARD2 trials for envudeucitinib. This next-generation TYK2 inhibitor demonstrated robust efficacy for patients suffering from moderate-to-severe plaque psoriasis. Both trials successfully met all primary and secondary endpoints with high statistical significance.
Key Findings from the Studies
- Approximately 65% of patients reached PASI 90 at Week 24.
- More than 40% achieved PASI 100 at Week 24, on average.
- Envudeucitinib surpassed placebo in skin clearance with a p-value of p < 0.0001.
- 74% of participants achieved PASI 75, and 59% reached static PGA of 0/1 by Week 16.
- Improvement from baseline was significant across all patient-reported outcomes, including itch severity and quality of life.
Notably, the rapid onset of action was evident as distinctions from placebo were recorded as early as Week 4.
Safety and Tolerability Profile
The treatment was generally well tolerated throughout the study period, aligning with data from Alumis' previous Phase 2 program. The frequency and severity of treatment-emergent adverse events (TEAEs) were primarily mild to moderate, with headaches, nasopharyngitis, and upper respiratory infections being the most commonly reported events. Notably, no new safety signals were detected.
Future Steps and Regulatory Plans
Alumis plans to submit a New Drug Application (NDA) for envudeucitinib to the FDA in the second half of 2026. Additional results from the ONWARD trials will be showcased at upcoming medical meetings. The CEO of Alumis, Martin Babler, emphasized the potential of envudeucitinib to transform treatment for IL-23/IL-17-driven diseases, positioning it as a “pipeline-in-a-pill.”
Expert Insights
Dr. Andrew Blauvelt, a leading dermatologist, noted that envudeucitinib represents an exciting new oral option for psoriasis treatment, potentially offering numerous patients an alternative to existing biologic therapies.
About the ONWARD Clinical Trials
The ONWARD program includes two randomized, double-blind, placebo-controlled trials engaging over 1,700 participants. Subjects were assigned to receive either envudeucitinib (40 mg twice daily), placebo, or apremilast, assessing efficacy through the Psoriasis Area Severity Index (PASI) and Physician's Global Assessment (PGA).
Conclusion and Call to Action
As Alumis continues its efforts towards clinical development, the medical community and investors are invited to attend the scheduled conference call and webcast today at 8:00 a.m. ET to delve deeper into these promising results. Access the live event on the company’s website under the Investors section.