BioRestorative Therapies Inc. (BRTX), a late-stage clinical regenerative medicine company, on Tuesday announced completion of Phase 2 dosing for BRTX-100 in the treatment of chronic lumbar disc disease (cLDD).
Shares rose by 20% on Tuesday.
BRTX-100 is a proprietary, autologous mesenchymal stem cell therapy that was hypoxically cultured to adapt to the harsh, low-oxygen, low-nutrient environment of the invertebral disc. The stem cell therapy is administered in a minimally invasive outpatient procedure in a dosage of 40 million cells per 1.5 cubic centimeters. BRTX-100 has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
The Phase 2 trial evaluating the safety and efficacy of BRTX-100 was a prospective, randomized, double-blind, sham-controlled single-disc study. Carried out on 99 patients over 52 weeks, the primary safety endpoint was determined by the frequency and severity of adverse events, and imaging-related findings. The primary efficacy responder endpoint was measured as an improvement from the baseline in pain and function using the visual analog scale and Oswestry disability index, respectively.
Preliminary blinded Phase 2 data suggest a favorable safety and efficacy profile for the therapy. Following the 52-week follow-period, topline results are expected in the second quarter of 2027.
The company has also completed a Type B meeting with the FDA and achieved alignment on the planned Phase 3 for BRTX-100 to facilitate a biologics license application (BLA) submission.
Additionally, BioRestorative is advancing BRTX-100 in a Phase 2 trial for the treatment of cervical discogenic pain.
BRTX closed Tuesday at $0.25, up 20.10%. In the overnight market, shares are trading at $0.24, down 0.20%.
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