Pasatru™ (garetosmab-grts) Demonstrates Zero New Heterotopic Ossification (HO) Lesions in Adult Fibrodysplasia Ossificans Progressiva (FOP) Patients During OPTIMA Trial Extension
Key Highlights
- ➤Pasatru showed zero new HO lesions from weeks 56 to 84 versus nine for placebo
- ➤Pasatru 10 mg/kg produced one clinician-assessed flare-up versus 17 for placebo
- ➤OPTIMA 56-week primary endpoint showed at least 90% reduction in new HO lesions
- ➤Skin and soft tissue infections rose dose-dependently, reaching 78% at 10 mg/kg
- ➤OPTIMA 2 Phase 3 trial in adolescents and children is planned for later this year
Expert Statements
Richard Keen, Professor and Director of the Metabolic Bone Disease Centre, Royal National Orthopaedic Hospital, London; global primary investigator of the OPTIMA trial
“FOP is a devastating, relentless condition in which every flare-up can bring anxiety around potential new, abnormal bone growth and resulting loss of mobility.”
Richard Keen, Professor and Director of the Metabolic Bone Disease Centre, Royal National Orthopaedic Hospital, London; global primary investigator of the OPTIMA trial
“What patients urgently need is long-term control over new HO lesions and flare-ups to help bring peace of mind.”
Richard Keen, Professor and Director of the Metabolic Bone Disease Centre, Royal National Orthopaedic Hospital, London; global primary investigator of the OPTIMA trial
“The 84-week data from the Phase 3 OPTIMA trial demonstrate sustained disease-modifying control alongside a generally well-tolerated safety profile, which is important for the adult FOP community.”
Pasatru is the first and only FDA-approved treatment demonstrating reductions in both new HO lesions and clinician-assessed flare-ups, per results of a 56-week placebo-controlled trial in adults with FOP
Late-breaking data presented at ASBMR show sustained efficacy of Pasatru and a consistent safety profile from weeks 56 to 84, supporting long-term disease control
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