Pasatru™ (garetosmab-grts) Demonstrates Zero New Heterotopic Ossification (HO) Lesions in Adult Fibrodysplasia Ossificans Progressiva (FOP) Patients During OPTIMA Trial Extension
Regeneron's Pasatru showed zero new heterotopic ossification lesions from week 56 to week 84 in the Phase 3 OPTIMA trial versus 9 new lesions for placebo. The 84-week data, presented at ASBMR, showed sustained flare-up reductions (1 flare-up on 10 mg/kg vs 17 for placebo) and a safety profile consistent with the 56-week results.
Key figures
- Drug Name
- Pasatru (garetosmab-grts)
- Phase Of Trial
- Phase 3
- Enrolled
- 63
- Trial name
- OPTIMA
- Extension completers
- 58
- Skin infection rates
- 33% placebo, 53% 3mg/kg, 78% 10mg/kg
- Flareups week84 placebo
- 17
- Ho lesion reduction week56
- 90%+
- Flareups week84 pasatru 3mg
- 14
- Flareups week84 pasatru 10mg
- 1
- New ho lesions week84 pasatru
- 0
- New ho lesions week84 placebo
- 9
AI analysis
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