BioRestorative Therapies Reports Promising Phase 2 Trial Results for Chronic Pain Treatment
BioRestorative Therapies' phase 2 trial results for BRTX-100 show significant improvement in function and pain reduction for chronic lumbar disc disease patients, potentially paving the way for accelerated FDA approval.
BioRestorative Therapies, a company focused on regenerative medicine, has reported encouraging results from its phase 2 clinical trial of BRTX-100, a treatment for chronic lumbar disc disease (cLDD). According to CEO Lance Alstodt, over 74% of participants showed more than 50% improvement in function, and over 72% reported a greater than 50% reduction in pain at 52 weeks, significantly surpassing the FDA's clinically meaningful threshold of 30%.
BRTX-100 utilizes a patient's own stem cells to target the root cause of chronic lower back pain, distinguishing it from treatments that merely mask pain. The company is on track to enroll 99 patients for the phase 2 trials, with an announcement expected soon. These results may lead to a pivotal trial or an accelerated path to FDA approval, marking a significant step forward in the treatment of chronic pain.
For more details on BioRestorative's innovative approach and future plans, watch the full interview here.