Business
Abeona Therapeutics Announces Strategy Update and 2021 Financial Results
EB-101 pivotal phase 3 VIITAL™ study in RDEB achieves target enrollment; top-line data expected in third quarter of 2022; gained FDA alignment on CMC
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"EB-101 pivotal phase 3 VIITAL™ study in RDEB achieves target enrollment; top-line data expected in third quarter of 2022; gained FDA alignment on CMC requirements for EB-101 including characterization and validation plans Company to focus R&D resources primarily on VIITAL™ data readout while actively pursuing potential commercialization partner for EB-101; maintain focus on preclinical eye gene therapy programs Pursue strategic partner to take over development activities for ABO-102 for MPS IIIA, while discontinuing development of ABO-101 for MPS IIIB Reduce operating expenses and extend cash runway to mid-2023 $50.9 million in cash resources as of December 31, 2021 Conference call scheduled for today at 8:30 a.m. ET NEW YORK and CLEVELAND, March 31, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today provided a business and strategy update and reported 2021 financial results. “We are committed to developing novel cell and gene therapies for patients with rare diseases with no approved treatment options,” said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona. “We are focused on EB-101 and, having recently achieved target enrollment in our pivotal Phase 3 VIITAL™ study, have increased confidence that we will share topline results in the third quarter of 2022. We also expect animal proof-of-concept data from our preclinical eye programs beginning in the second half of 2022 that could support pre-IND meetings with the FDA. We believe the strategic steps announced today reflect the operating discipline needed to extend our cash runway beyond these near-term catalysts.” Strategy and Business Update Following a comprehensive portfolio review, Abeona announced today that it is focusing research and development (R&D) resources on the topline data readout for its EB-101 pivotal Phase 3 VIITAL™ study while the Company actively pursues a potential commercialization partner for EB-101.Target enrollment was achieved in Abeona’s EB-101 pivotal Phase 3 VIITAL™ study for recessive dystrophic epidermolysis bullosa (RDEB). The Company anticipates topline results for the co-primary endpoints related to wound healing and pain reduction measured at 24 weeks post treatment in the third quarter of 2022. Abeona received positive feedback from the U.S. Food and Drug Administr...