Alumis eyes late-stage lupus study despite trial miss (updated)
UPDATE 1-Alumis eyes late-stage lupus study despite trial miss Adds details and background throughout
Sept 1 (Reuters) - Alumis ALMS.O said on Tuesday it plans to advance its experimental drug for a type of immunity-related condition in a smaller subset of patients, even after the treatment failed to meet the main goal of a mid-stage trial.
Its shares slumped more than 55% in premarket trading, as Wall Street had viewed the study as an important test in a disease long seen as a drug-development graveyard.
Here are some details:
The drug developer focused on autoimmune diseases was testing the oral treatment, envudeucitinib, in 408 adults with moderate-to-severe systemic lupus erythematosus (SLE) over 48 weeks to see if it could significantly ease the symptoms.
Despite the trial's failure to meet its main goal, the San Francisco-based company said it plans to talk with regulators about starting a late-stage trial.
Alumis said a specific subgroup of patients with higher interferon activity, a marker linked to lupus severity, showed strong improvement, including on the study's main measure of disease activity.
According to the company, these patients are thought to respond better to therapies targeting the interferon pathway and made up a smaller share of the trial population than expected, which Alumis said contributed to the overall study miss.
The drug, which works by blocking a key immune-system protein called TYK2 to calm the overactive inflammation, was generally well tolerated and showed no new safety concerns during the study.
Over 200,000 people in the U.S. are estimated to have SLE, according to the Centers for Disease Control and Prevention.
Alumis also said it remains on track to file for U.S. regulatory approval of the drug to treat moderate-to-severe plaque psoriasis, a skin condition, in the fourth quarter of 2026 after previously reporting positive trial results.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Leroy Leo and Shilpi Majumdar)
((Kamal.Choudhury@thomsonreuters.com;))
Recent news on Alumis
See all newsBrief: Alumis Says Envudeucitinib Improves Psoriasis Symptoms in Phase 3 Data
U.S. RESEARCH ROUNDUP-Adobe, Dell Technologies, Zscaler
Alumis set for worst day after lupus drug misses main goal in mid-stage trial
Alumis eyes late-stage lupus study despite trial miss (updated)
Alumis tumbles after lupus drug misses main goal in mid-stage trial