Business
Abeona Therapeutics Provides Regulatory Update Ahead of Pivotal Phase 3 Clinical Trial for EB-101 in Recessive Dystrophic Epidermolysis Bullosa
Company to provide additional transport stability data points in response to FDA Clinical Hold LetterCMC clearance for VIITAL™ trial anticipated in Q4
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"Company to provide additional transport stability data points in response to FDA Clinical Hold LetterCMC clearance for VIITAL™ trial anticipated in Q4 2019Investor conference call today, Monday, September 23 at 09:30 a.m. ET NEW YORK and CLEVELAND, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that it has recently received a clinical hold letter from the U.S. Food and Drug Administration (FDA) clarifying that the FDA will not provide approval for the Company to begin its planned Phase 3 clinical trial for EB-101 until it submits to the FDA additional data points on transport stability of EB-101 to clinical sites. Over the last 12 months, the Company has worked closely with the FDA to address and narrow open Chemical, Manufacturing and Controls (CMC) items and has been working to resolve this one item identified in the FDA Clinical Hold Letter. The Company continues to anticipate receiving CMC clearance for VIITAL™ trial in Q4 2019.\n “Initiating the VIITAL™ pivotal Phase 3 trial for EB-101 is the Company’s top priority,” said João Siffert, M.D., Chief Executive Officer of Abeona. “Efforts to gather supplemental data points on transport stability of EB-101 are ongoing and we are confident that the requested additional data will be submitted to the FDA promptly. Looking ahead, we believe that completion of our CMC work coupled with the durable safety and efficacy data, now out to five years in some patients, will ultimately be critical to support a future Biologics License Application. We remain deeply committed to advancing EB-101 to provide a desperately needed treatment for RDEB patients.” The Company will hold a conference call scheduled for Monday, September 23 at 09:30 a.m. ET. Interested parties are invited to participate in the call by dialing 844-369-8770 (toll-free domestic) or 862-298-0840 (international) or via webcast at https://www.investornetwork.com/event/presentation/53728. About EB-101EB-101 is an investigational, autologous, gene-corrected cell therapy poised to enter late-stage development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. Treatment with EB-101 involves using gene transfer to deliver COL7A1 genes into a patient’s ow...