BioRestorative to Present Blinded Phase 2 Data from 45-Patient Study and FDA Phase 3 Alignment
BioRestorative will unveil blinded Phase 2 data on approximately 45 patients reporting pain and function scale improvements and safety tolerability at the March 28 Orthopaedic Research Society meeting. After a recent FDA Type B meeting it secured alignment on Phase 3 endpoints, statistical powering, dosing strategy and CMC framework.
1. Presentation of Blinded Phase 2 Data
BioRestorative will present new blinded results from approximately 45 patients in its Phase 2 trial evaluating hypoxic-cultured mesenchymal stem cells for chronic lumbar disc disease on March 28 at the Orthopaedic Research Society Annual Meeting. The poster will cover key pain and function scale outcomes alongside safety and tolerability assessments.
2. FDA Type B Meeting Alignment
Following a Type B meeting, the company achieved FDA concurrence on primary endpoints, statistical powering assumptions, dosing strategy and its CMC framework for Phase 3 development of BRTX-100, with no safety concerns raised. This alignment streamlines the investigational new drug pathway for late-stage clinical planning.
3. Next Steps and Phase 3 Readiness
BioRestorative plans to unblind the Phase 2 study and issue a detailed pre-market release of the data on March 28. The company will then finalize Phase 3 trial protocols, prepare an IND submission, and advance BRTX-100 toward potential commercialization for non-surgical treatment of chronic lumbar disc disease.