- No serious adverse events reported in the BRTX-100 Phase 2 trial for chronic lumbar disc disease.
- The trial exceeds FDA requirements with over 30% improvement in both ODI and VAS measures.
- 70% of subjects showed more than 50% improvement in pain and function at 52 weeks; this was sustained at 66.66% through 104 weeks.
BioRestorative Therapies, Inc. (NASDAQ:BRTX) has announced promising preliminary results from its Phase 2 clinical trial of BRTX-100, a potential treatment for chronic lumbar disc disease (cLDD). The data, shared at the ISCT 2025 Annual Meeting, indicates a strong safety profile with no serious adverse events (SAEs) and no dose-limiting toxicity recorded between 26 to 104 weeks using a dose of 40 million cells.
The trial results show significant efficacy trends that exceed the FDA's threshold requirement of over 30% improvement in both the Oswestry Disability Index (ODI) and the Visual Analog Scale (VAS). In particular, the percentage of subjects achieving more than a 50% improvement in both ODI and VAS increased from 0% at week 2 to 70% at week 52, and maintained at 66.66% through week 104.
This sustained response suggests potential long-term benefits for patients with cLDD, offering a new therapeutic option that could complement existing treatments like surgery or physical therapy. The study involves up to 99 participants, enrolled at 16 clinical sites across the United States, with a 2:1 randomization to BRTX-100 or placebo groups. BioRestorative Therapies' progress in this area highlights its commitment to advancing stem cell therapies in degenerative disc diseases.
