Beeline's oral lupus drug afimetoran meets primary endpoint in Phase 2, paving way for Phase 3

Beeline Medicines announced that its oral small-molecule inhibitor afimetoran achieved the primary endpoint in a 48-week Phase 2 trial in patients with systemic lupus erythematosus (SLE).

The trial compared three doses of afimetoran with placebo and all dose groups showed a statistically significant higher SLE Responder Index-4 (SRI-4) response rate, with a p-value reported as less than 0.001.

Secondary efficacy measures aligned with the primary results, and safety was consistent with earlier Phase 1 data. The company said the data support moving the program into pivotal Phase 3 studies for two lupus indications.

Beeline, which emerged from stealth in April after raising $300 million and a $126 million Series A extension, is positioning afimetoran as a potential oral therapy for lupus, a disease with limited treatment options.