Abeona Treats First Patient In Pivotal Gene Therapy Study
Zacks Investment Research | Mar 17, 2020 09:10PM ET
Abeona Therapeutics Inc. (NASDAQ:ABEO) announced that it has treated the first patient in the pivotal phase III study — VIITAL — evaluating its lead pipeline candidate, EB-101, in patients with recessive dystrophic epidermolysis bullosa (“RDEB”). The rare connective tissue disorder, RDEB, is characterized by severe skin wounds and can lead to systemic complications.
The study is being conducted by investigators at Stanford University Medical Center and enrollment in it is ongoing.
Currently, there are no FDA-approved therapies for treating RDEB. A successful development of the gene-corrected cell therapy candidate, EB-101 will be a major boost for the clinical-stage pharma company.
Please note that the company has successfully completed a phase I/II study on EB-101 in RDEB patients. Data from the study showed that treatment with the candidate resulted in sustained and durable wound healing. It also had a favorable safety profile.
Shares of Abeona have lost 37.7% so far this year compared with the industry ’s decline of 12.7%.
Apart from EB-101, the company has two other clinical-stage pipeline candidates in its portfolio. The candidates — ABO-102 and ABO-101 — are adeno-associated virus (“AAV”)-based gene therapies, which are being developed for treating Sanfilippo syndrome type A and Sanfilippo syndrome type B, respectively.
The company is also planning to initiate a phase I/II study to evaluate pre-clinical AAV-based gene therapy candidate, ABO-202 in patients with CLN1 disease soon. An investigational new drug application to support the initiation of the study was approved by the FDA in May 2019.
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