Abeona Therapeutics (NASDAQ:ABEO) treated the first patient in its Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
The trial, being conducted at Stanford University Medical Center, will assess EB-101 in up to 15 RDEB patients, with some 30 chronic wound sites treated in total. The primary outcome measure is wound healing, comparing treated with untreated wound sites on the same patient.
“This achievement confirms that Abeona can deliver EB-101 in a study setting that closely parallels its potential real-world application,” Dr. Joao Siffert, Abeona’s CEO, said in a statement.
“We remain confident that VIITAL will replicate results from the Phase 1/2 trial demonstrating that EB-101 treatment resulted in sustained and durable wound healing with a favorable safety profile,” he added.