Clinical TrialMay 26, 2026, 11:01 AM
BioRestorative Therapies Completes Dosing in BRTX-100 Phase 2 Trial
AI Summary
BioRestorative Therapies announced the completion of treatment administration for all 99 patients in its fully enrolled Phase 2 clinical trial evaluating BRTX-100 for chronic lumbar disc disease. The study is now moving into blinded follow-up, with topline safety and efficacy data anticipated in Q2 2027. This milestone follows a positive Type B meeting with the FDA, where the agency provided alignment on key elements for the late-stage development pathway, and the company continues Phase 3 readiness activities.
Key Highlights
- Phase 2 BRTX-100 trial completed treatment administration in 99 patients for chronic lumbar disc disease.
- Subjects were randomized in a 2:1 ratio to receive BRTX-100 or control treatment.
- Primary efficacy endpoint is at least 30% improvement in pain and function at week 52.
- Topline safety and efficacy data from the Phase 2 study are expected in Q2 2027.
- BRTX-100 is an autologous mesenchymal stem cell therapy with 40 x 10^6 cells per injection.
- Patients required chronic low back pain for at least 6 months and failure of conservative therapy for 6 months.
- BRTX-100 has received Fast Track designation from the U.S. FDA.
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