Regeneron provides update on the garetosmab phase II LUMINA-1 trial in fibrodysplasia ossificans progressiva .

Regeneron notified clinical investigators to pause dosing of the investigational therapy garetosmab (REGN2477) in the ongoing Phase II LUMINA-1 trial in patients with the ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP) . The decision was based on reports of fatal serious adverse events in the trial during the open-label portion, during which all patients received active treatment. These deaths are being further investigated to understand if they are related to garetosmab treatment. During the 28-week double-blind treatment period, there were no deaths in the trial. Regeneron also shared this update with the trial’s Independent Data Monitoring Committee and regulatory authorities,and will conduct a review of the trial data to date, to better understand the benefit/risk profile of garetosmab in people with FOP.