BioRestorative Reports 75% Pain Relief at 52 Weeks, No Safety Events
BioRestorative Therapies’ Phase 2 trial of BRTX-100 in chronic lumbar disc disease showed 75% of patients reporting over 50% pain relief on VAS and 74.6% achieving similar functional gains on ODI at 52 weeks, with no dose-limiting safety events. FDA reviewed and aligned on Phase 3 endpoints and development framework.
1. Phase 2 Efficacy Results
Blinded data from the Phase 2 trial of BRTX-100 demonstrated that 75% of treated patients reported over 50% improvement in Visual Analog Scale pain scores and 74.63% achieved greater than 50% improvement on the Oswestry Disability Index at 52 weeks, with sustained benefits in smaller cohorts at 104 weeks.
2. Safety and Tolerability
No adverse events related to dose-limiting toxicities were reported throughout the trial, reinforcing a favorable safety profile for hypoxic-cultured mesenchymal stem cell injections in chronic lumbar disc disease patients.
3. FDA Alignment and Next Steps
Following a Type B meeting with the U.S. Food and Drug Administration, BioRestorative secured agreement on primary endpoints, statistical powering, dosing strategy and CMC framework for a potential Phase 3 trial and is preparing protocol planning and registrational activities.