Abeona Therapeutics is ready to initiate its pivotal Phase III clinical trial, VIITAL, to evaluate EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).

The move comes after the US Food and Drug Administration (FDA) removed its clinical hold and provided clearance for the study following the submission of additional data points by Abeona on the transport stability of EB-101 to clinical sites.

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Abeona expects to initiate the VIITAL study of the autologous, gene-corrected cell therapy EB-101 during the first quarter of next year.

Abeona Therapeutics CEO João Siffert said: “Recently published long-term follow-up data from our Phase I/II trial leaves us increasingly confident that EB-101 can provide durable healing for large, chronic wounds that afflict many RDEB patients.

“The success in building and qualifying a state-of-the-art GMP manufacturing facility also represents a critical step toward bringing this novel product to patients in dire need of effective treatment.”

The multi-centre, randomised VIITAL Phase III trial will evaluate EB-101 in ten to 15 RDEB patients, with approximately 30 chronic wound sites treated in total.

The trial’s primary endpoint will be the proportion of wounds with a greater than 50% healing at three months compared to untreated wound sites on the same patient.

Secondary endpoints of the study include the patient’s global impression of change in pain from baseline, as well as other patient-reported outcomes assessing pain during dressing changes, pain impact and physical function.

Data from a Stanford University Phase I/II trial that evaluated EB-101 based on two to five years of follow-up showed that EB-101 provided durable wound healing for RDEB patients.

RDEB is a rare connective tissue disorder characterised by severe skin wounds that cause pain and can lead to systemic complications.