Alumis reports 48‑week scalp and itch data from Phase 3 psoriasis program
The continuous-treatment cohort showed symptom gains as Alumis targets a fourth-quarter U.S. drug application.
Adrian Kessler
More than 80 per cent of continuously treated patients had clear or almost clear scalps at 48 weeks, as Alumis Inc. NASDAQALMS released additional Phase 3 envudeucitinib psoriasis data on Friday. The findings add symptom evidence ahead of a planned fourth-quarter 2026 U.S. drug application, although the 773-patient extension analysis has no concurrent placebo group.
The Oct. 9 company release distributed by GlobeNewswire highlights scalp disease, itch and quality of life across the ONWARD1, ONWARD2 and ONWARD3 studies. More than 70 per cent of the continuous-treatment group had a Dermatology Life Quality Index score of zero or one at week 48, indicating little or no reported effect on daily activities.
Alumis is a small-cap South San Francisco developer of oral treatments for immune-mediated diseases.
Alumis shares NASDAQALMS closed at US$6.97 on Nasdaq Thursday, according to the quote page as of 4:00:01 p.m. EDT. The release was distributed at 4 a.m. EDT on Oct. 9, before the U.S. stock market opened, so the close does not measure a reaction to the data.
The Symptom Figures Came From an Extension Cohort
The parallel ONWARD1 and ONWARD2 trials randomized 1,771 adults to envudeucitinib, placebo or apremilast. The trials used a 2:1:1 allocation; patients assigned the investigational drug received 40 milligrams twice daily. The co-primary endpoints at week 16 were a 75 per cent improvement in the Psoriasis Area and Severity Index and a physician's assessment of clear or almost clear skin, each compared with placebo.
The March 28 detailed results reported PASI 90 skin-clearance responses. At week 16 in ONWARD1, 59.9 per cent of treated patients met that bar, compared with 4.8 per cent on placebo. The corresponding ONWARD2 figures were 53.1 per cent and 4.3 per cent. Those controlled results are separate from the new symptom percentages.
About one-third of envudeucitinib patients in the initial trials reported at least a four-point improvement in itch by week two, Alumis said Friday. By week 16, about 40 per cent reported complete itch resolution and roughly 60 per cent reported minimal or no itch. The newly highlighted symptom percentages were presented without matching placebo or apremilast figures or p values.
ONWARD3 enrolled 1,509 people, but the 48-week analysis highlighted Friday used non-responder imputation for 773 who had taken envudeucitinib continuously since the initial trials. Nearly 80 per cent sustained a clinically meaningful itch reduction through week 48. Alumis also said patients who switched from placebo or apremilast improved after switching, but did not provide matching arm-by-arm percentages in its summary.
"With our fourth-quarter 2026 NDA submission firmly on track, our organization is focused on regulatory execution and building the foundation designed to bring this next-generation therapy to patients," Alumis chief executive Martin Babler said in the Oct. 9 release.
Alumis described envudeucitinib as generally well tolerated across the ONWARD program and reported no new safety signals with longer exposure in ONWARD3. The release did not quantify adverse events for the newly highlighted extension cohort.
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Cash Runway Extends Beyond the Planned Filing
Apremilast was the trials' active oral comparator, so its arm supplies a more useful test of relative performance than a cross-trial ranking of oral psoriasis drugs. The October symptom highlights give no matching apremilast percentages; Alumis's claim that its week-48 complete skin clearance is the highest reported among oral therapies remains a company comparison across separate studies.
Alumis reported US$502.3 million in cash, cash equivalents and marketable securities at June 30 in its Aug. 13 quarterly release. Under its operating plan, the company said that balance could fund expenses and capital requirements into the fourth quarter of 2027, a period extending beyond the planned psoriasis filing.
The next scheduled milestone is Alumis's New Drug Application for moderate-to-severe plaque psoriasis in the fourth quarter of 2026, which ends Dec. 31. Submitting the application by then will test the company's timetable for putting the Phase 3 package before the FDA.
