Alumis eyes late-stage lupus study despite trial miss

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.

• 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)