Alumis Inc. (NASDAQ:ALMS) on Monday shared topline data from its ongoing ONWARD3 long-term extension study, demonstrating that its investigational oral therapy, envudeucitinib, achieved leading skin clearance rates for patients with immune-mediated diseases.
Alumis stock initially traded higher Tuesday before pulling back and turning negative.
Exceptional Efficacy And Sustained Relief
The next-generation TYK2 inhibitor, which is precision-engineered for maximum 24-hour target suppression, showed the highest reported Psoriasis Area and Severity Index (PASI) 100 response rates compared to current and experimental oral treatments.
Out of 1,509 participants who transitioned into the ONWARD3 trial from the earlier ONWARD1 and ONWARD2 studies—an impressive rollover rate of over 85%—researchers analyzed 773 individuals who underwent up to 48 weeks of continuous care.
Findings revealed that 75% of these patients reached PASI 90, while 54% attained PASI 100.
Furthermore, among those who entered the extension study already displaying PASI 90 and PASI 100 responses, roughly 90% and 80% maintained their skin clearance, respectively, for the reported duration.
Broad Analysis And Favorable Safety
A broader integrated analysis covering 890 subjects originally randomized to the drug showed 66% achieving PASI 90 and 47% reaching PASI 100 after 48 weeks of treatment.
The medication maintained a favorable tolerability profile, mirroring previous trials without any newly identified safety concerns.
“These long-term data, including the robust 54% PASI 100 response, further validate the strength of envudeucitinib’s precision-engineered design for continuous, maximal TYK2 inhibition and underscore its highly competitive clinical profile,” said Jörn Drappa, Chief Medical Officer of Alumis.
“This level of performance reinforces envudeucitinib’s potential to become a leading oral therapy for moderate-to-severe plaque psoriasis and a ‘pipeline-in-a-pill’ for immune-mediated diseases driven by IL-23, IL-17, and Type I interferon pathways,” Drappa added.
Regulatory Steps And Future Milestones
The company aims to file a New Drug Application with the U.S. Food and Drug Administration in the fourth quarter to seek approval for treating moderate-to-severe plaque psoriasis.
Additionally, the clinical development pipeline continues to progress, with topline results from the Phase 2b LUMUS trial for systemic lupus erythematosus projected for the third quarter of 2026.
ALMS Price Action: Alumis shares were down 12.71% at $24.03 at the time of publication on Tuesday, according to Benzinga Pro data.
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