Alumis (NASDAQ:ALMS) surged as much as 82% in early trading Tuesday after its experimental oral drug, envudeucitinib, outperformed both a placebo and Amgen’s blockbuster Otezla in two Phase 3 trials for moderate-to-severe plaque psoriasis.
The results position the South San Francisco-based biotech to challenge established oral therapies and injectables in an $11 billion market by offering "biologic-like" skin clearance in a twice-daily pill.
The parallel ONWARD1 and ONWARD2 studies, which enrolled over 1,700 patients, showed that approximately 65% of those taking envudeucitinib achieved a 90% reduction in skin symptoms (PASI 90) by Week 24.
Notably, more than 40% of patients reached complete skin clearance (PASI 100).
The drug also demonstrated a rapid onset of action, with statistically significant separation from the placebo group as early as four weeks into the trial.
Safety remained a key highlight for investors; envudeucitinib maintained a profile consistent with previous mid-stage studies, with no new safety signals identified through 24 weeks.
The most common adverse events included headache, acne, and upper respiratory tract infections.