EXCLUSIVE: BioRestorative Concludes Enrollment For Safety Run-In Component Of Cell Therapy Study For Chronic Lower Back Pain

BioRestorative Therapies Inc BRTX has completed enrollment for the safety run-in component of its Phase 2 study of BRTX-100 targeting patients suffering from chronic lumbar disc disease (cLDD).

What Happened: BRTX-100 is the company's lead clinical candidate, a cell-based therapeutic engineered to target areas of the body with little blood flow.

BRTX-100 is currently in a Phase 2 trial for cLDD to evaluate the safety and preliminary efficacy of a single dose of BRTX-100.

Ninety-nine eligible patients will be randomized at up to 15 clinical sites in the U.S. to receive BRTX-100 or control in a 2:1 fashion. 

Why It Matters: The clinical data from the safety run-in is scheduled to be released in the second half of 2023.

Lance Alstodt, CEO of BioRestorative Therapies, stated, "The completion of patient recruitment and enrollment for the safety run-in component of our Phase 2 study of BRTX-100 is a very significant milestone for our company. Positive safety data would enable us to initiate unrestricted enrollment across all clinical sites and establish a strong safety profile for BRTX-100."

In March, BioRestorative entered into an agreement with Bruder Consulting & Venture Group, a full-service strategic advisory, to assist the company in seeking FDA approval for the expanded clinical application of BRTX-100.

Price Action: BRTX shares closed at $3.90 on Friday.