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Getting the latest healthcare news for you
Alumis isn't giving up on its lupus drug just yet. Despite envudeucitinib failing to meet the primary endpoint in a mid-stage trial of 408 SLE patients, the company is eyeing a late-stage study focused on a subgroup with high interferon activity — patients who showed strong improvement. Shares still tumbled over 55% in premarket trading.
Alumis isn't throwing in the towel on its lupus drug. The San Francisco-based autoimmune drug developer reported that its oral TYK2 inhibitor, envudeucitinib, failed to meet the primary endpoint in a 48-week, mid-stage trial of 408 adults with moderate-to-severe systemic lupus erythematosus (SLE). Wall Street reacted sharply — shares dropped more than 55% in premarket trading — given that SLE has long been considered a notoriously difficult space for drug development.
Still, Alumis sees a path forward. The company plans to engage regulators about launching a late-stage trial focused on a specific subgroup: patients with higher interferon activity, a biomarker tied to lupus severity. This subgroup showed meaningful improvement on the trial's primary disease activity measure, and Alumis believes they respond better to therapies targeting the interferon pathway. The subgroup made up a smaller share of the trial population than anticipated, which the company says contributed to the overall miss. The drug was generally well tolerated with no new safety concerns identified.
By the Numbers:
Why it matters: SLE remains one of the hardest diseases to treat and develop drugs for. Alumis's subgroup-focused pivot could offer a more targeted path to approval — and potentially a meaningful new option for lupus patients with high interferon activity, a population with limited effective therapies.
