Clinical TrialMay 7, 2026, 12:01 PM
BioRestorative BRTX-100 Phase 2 shows 52% patients with 50%+ pain/function improvement
AI Summary
BioRestorative Therapies announced expanded blinded data from its fully enrolled Phase 2 clinical trial for BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease. The data, presented at ISCT 2026, showed that 52% of evaluable patients achieved at least 50% improvement in both VAS pain and ODI function at 52 weeks, with no dose-limiting toxicity safety signals. The company continues to observe meaningful improvements across key pain and functional outcome measures as it advances towards Phase 3 readiness activities, supported by BRTX-100's Fast Track designation and positive FDA Type B meeting outcome.
Key Highlights
- 52% of evaluable patients achieved at least 50% improvement in both VAS pain and ODI function at 52 weeks.
- The 52-week follow-up cohort more than doubled from 12 to 25 patients.
- 56% of evaluable patients reported at least 50% improvement in VAS pain at 52 weeks, with an average improvement of 71.4%.
- 64% of evaluable patients achieved at least 50% improvement in ODI function at 52 weeks, with an average improvement of 73.6%.
- No dose-limiting toxicity safety signals were observed.
- BRTX-100 has received Fast Track designation from the U.S. FDA.
- Company initiated Phase 3 enabling activities with a goal to submit a Phase 3 IND application later in 2026.
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