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From Phase 2 Trial Results To Expansion Mode: A Look At BioRestorative's Novel Approach To Treating Chronic Pain

By Meg Flippin Benzinga

BioRestorative Therapies is a regenerative medicine company that wants to alleviate chronic lower back pain, obesity and diabetes and is developing stem cell therapies to achieve those goals. The company’s flagship product candidate, BRTX-100, just completed a phase 2 clinical trial for chronic lumbar disc disease (cLDD), which Alstodt was on hand to discuss with Benzinga.

“Data from the first 36 patients was highly encouraging," Alstodt told Benzinga in the interview. “At 52 weeks over 74% of participants demonstrated greater than 50% improvement in function and over 72% reported a greater than 50% reduction in pain, both substantially exceeding the FDA’s clinically meaningful threshold of 30%,” Alstodt said the phase 2 outcome set the stage for a pivotal trial or even accelerated path to approval. 

BRTX-100 is an autologous stem cell product for chronic lower back pain. It uses a patient’s stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process. During the interview, Alstodt told Benzinga that he thinks what makes BRTX-100 different is that instead of masking the pain, like opioids and injectables, the BioRestorative product candidate is targeting the root cause. The goal of the phase 2 trials is to enroll a total of 99 patients, which the CEO said is tracking well. An announcement on that front is expected soon. 

But that’s not all Alstodt revealed in this wide-ranging interview. From BioRestorative’s expansion plans to what’s next for the company, the executive had a lot to share in this must-watch All Access interview. 

Watch the full interview here: 

https://www.youtube.com/watch?v=7NrNkBtUT4s

Featured image from Shutterstock.

This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.

This content was originally published on Benzinga. Read further disclosures here.

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