BioRestorative Therapies Doses Last Patient in BRTX-100 Clinical Trial

BioRestorative Therapies announced that the last patient has been dosed in its fully enrolled Phase 2 clinical trial evaluating BRTX-100 for the treatment of chronic lumbar disc disease, completing treatment administration in the Company's lead clinical program and advancing the study into the next stage of blinded follow-up ahead of expected topline safety and efficacy data in Q2 2027. The prospective, randomized, double-blind, sham-controlled, single-disc Phase 2 study enrolled approximately 99 patients across U.S. clinical sites and is designed to evaluate the safety and preliminary efficacy of BRTX-100 in patients with painful chronic lumbar disc disease. Subjects were randomized in a 2:1 ratio to receive either BRTX-100 or control treatment. The primary safety endpoints for the trial include the frequency and severity of adverse events and serious adverse events, as well as imaging-related findings. The primary efficacy responder endpoint is defined as at least a 30% improvement from baseline in both pain -- as measured by the Visual Analog Scale -- and function --as measured by the Oswestry Disability Index, at week 52. Study follow-up assessments are being conducted at weeks 2, 12, 26, 52 and 104, with MRI evaluations at baseline, week 52 and week 104.