BioRestorative Completes Phase 2 Dosing in 99-Patient BRTX-100 Trial, Eyes Phase 3 Readiness
BRTX•BioRestorative has completed dosing in its fully enrolled Phase 2 BRTX-100 trial of 99 chronic lumbar disc disease patients and advanced to blinded follow-up ahead of topline safety and efficacy data in Q2 2027. The FDA Type B meeting raised no safety concerns and aligned on key Phase 3 development elements.
1. Phase 2 Dosing Completion
BioRestorative has administered a single intradiscal injection of 40 × 10^6 mesenchymal stem cells to all 99 enrolled chronic lumbar disc disease patients in its randomized, double-blind, sham-controlled Phase 2 study of BRTX-100. Treatment administration is now complete, and the study has entered blinded follow-up across multiple assessment points.
2. Study Design and Endpoints
The trial randomized subjects 2:1 to BRTX-100 or control, with primary safety endpoints tracking adverse events, serious adverse events and imaging findings. The primary efficacy endpoint requires at least a 30% baseline improvement in pain (Visual Analog Scale) and function (Oswestry Disability Index) at week 52, with follow-ups at weeks 2, 12, 26, 52 and 104 and MRI evaluations at baseline, week 52 and week 104.
3. FDA Alignment and Phase 3 Readiness
Following a Type B meeting, the FDA did not raise clinical safety concerns and provided alignment on key elements of late-stage development. BioRestorative is advancing Phase 3 preparation activities, aiming to streamline trial design and regulatory pathways based on this feedback.
4. Outlook and Future Milestones
Blinded follow-up continues toward topline safety and efficacy data expected in Q2 2027. The company plans to reduce expenses, redirect resources toward its BioCosmeceutical platform and leverage Fast Track designation to accelerate its regenerative spine program.
