FDA recommends accelerating Abeona’s gene therapy program

Story excerpt provided by Crain’s Cleveland Business.

Written by Lydia Coutré.

Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company, announced this week that the U.S. Food and Drug Administration has recommended accelerating its gene therapy program into a Phase 3 trial.

Abeona, which has offices in Cleveland, New York and Dallas, focuses on developing gene therapies for life-threatening rare diseases. Its EB-101 product is a gene therapy in which a gene is inserted into a patient’s skin cells to treat the underlying disease in Recessive Dystrophic Epidermolysis Bullosa (RDEB), a painful and devastating rare skin disease. The company is working with the FDA on the final Phase 3 clinical trial design, planned to begin early next year, according to a news release.

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Originally published July 19, 2017.