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.