Alumis' Envudeucitinib Phase 3 Psoriasis Trials Meet All Endpoints, Demonstrating Leading Skin Clearance

summarizeSummary

Alumis Inc. announced positive topline results from its Phase 3 ONWARD clinical trials for envudeucitinib in moderate-to-severe plaque psoriasis, meeting all primary and secondary endpoints with high statistical significance and demonstrating leading skin clearance.

check_boxKey Events

• Positive Phase 3 Results

  Envudeucitinib met all primary and secondary endpoints with high statistical significance in two Phase 3 trials (ONWARD1 and ONWARD2) for moderate-to-severe plaque psoriasis.

• Strong Efficacy Demonstrated

  The drug achieved superior skin clearance compared to both placebo and apremilast, with approximately 65% of patients reaching PASI 90 and over 40% reaching PASI 100 at Week 24.

• Favorable Safety Profile

  Envudeucitinib was generally well-tolerated through Week 24, with a safety profile consistent with its Phase 2 program and no new safety signals observed.

• NDA Submission Planned

  Alumis intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026.

auto_awesomeAnalysis

The successful Phase 3 readout for envudeucitinib significantly de-risks Alumis' lead drug candidate, positioning it as a potential best-in-class oral therapy for plaque psoriasis. The strong efficacy data, including high rates of PASI 90 and PASI 100, combined with a favorable safety profile, supports the company's plan to submit a New Drug Application to the FDA in the second half of 2026. This milestone is crucial for the company's future revenue potential and validates its TYK2 inhibitor platform.