Amgen's Daxdilimab Shows Promising Results in Discoid Lupus Trial

Amgen's phase 2 trial for its monoclonal antibody daxdilimab has shown promising results in treating discoid lupus, a rare autoimmune condition. The company revealed that the lower dose of daxdilimab led to a 6-point reduction in disease severity, compared to a 5.7-point drop with the higher dose. This corresponds to a 50% reduction in lupus disease area and severity.

The trial, which involved 72 patients, met both primary and secondary endpoints. Patients on daxdilimab experienced significant improvements in their quality of life, with 61.7% and 62.1% of those on the low and high doses reaching a 50% reduction in disease severity, compared to 23.7% in the placebo cohort.

The antibody was well-tolerated, with no serious adverse events or deaths reported. Amgen is now taking steps to advance daxdilimab into a registrational phase of development for discoid lupus. The company had previously acquired daxdilimab from Horizon Therapeutics in 2023.