Regeneron announced positive 84-week data from the Phase 3 OPTIMA trial extension for Pasatru™ (garetosmab-grts) in adults with fibrodysplasia ossificans progressiva (FOP). The results were presented at the American Society for Bone and Mineral Research Annual Meeting.
Between weeks 56 and 84, patients treated with Pasatru had zero new heterotopic ossification lesions, or areas of abnormal bone growth. The results demonstrate sustained, long-term disease control with the recently FDA-approved drug.
FOP is an ultra-rare, debilitating genetic disorder in which soft tissues progressively turn into bone. Pasatru is the first and only approved treatment shown to reduce both new bone lesions and disease flare-ups. Its safety profile at 84 weeks remained consistent with earlier findings.