Admin_Adham
Jump to Key Points Sept 1 (Reuters) - Alumis 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.
- Envudeucitinib missed phase 2 primary endpoint in 408 adults with moderate-severe SLE.
- Alumis plans regulator talks for phase 3 in higher-interferon SLE subgroup.
- Higher interferon activity subgroup showed strong response, incl main disease-activity measure.
- Drug was generally well tolerated; no new safety signals reported.
- U.S. SLE prevalence >200,000; psoriasis filing remains planned Q4 2026.
• 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)
