Abeona Therapeutics to Initiate Phase 3 Clinical Trial of B-101

- December 9th, 2019

The company announced that the US Food and Drug Administration has removed its clinical hold on its Phase 3 clinical trial of EB-101.

Abeona Therapeutics (NASDAQ:ABEO) has announced that the US Food and Drug Administration (FDA) has cleared the company to initiate a Phase 3 clinical trial evaluating EB-101 to treat recessive dystrophic epidermolysis bullosa (RDEB).

As quoted in the press release:

The FDA removed the clinical hold following the Company’s submission of additional data points on transport stability of EB-101 to clinical sites. Abeona expects to initiate the VIITAL™ study in first quarter of 2020.

“The Abeona team has worked diligently to provide a prompt and thorough response to the FDA, enabling us to proceed with our pivotal Phase 3 trial for EB-101,” said João Siffert, M.D., Chief Executive Officer of Abeona. “Recently published long-term follow up data from our Phase 1/2 trial leaves us increasingly confident that EB-101 can provide durable healing for large, chronic wounds that afflict many RDEB patients. We are now focused on initiating the VIITAL™ study in the first quarter of 2020. The success in building and qualifying a state-of-the-art GMP manufacturing facility also represents a critical step toward bringing this novel product to patients in dire need of effective treatment.”

With two to five years of follow-up, data from a Phase 1/2 clinical trial conducted by Stanford University evaluating EB-101 showed that the gene-corrected cell therapy provided durable wound healing for RDEB patients, including for the largest, most challenging wounds that constitute the majority of wounds in this population.

Click here to read the full press release.

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