Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced on Thursday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for AVB-114, its lead therapeutic candidate for Crohn's perianal fistulas.

Fast Track designation is intended to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need.

Positive results from a Mayo Clinic Phase I trial (STOMP-I) led to the founding of Avobis Bio and primary endpoint results from the Phase II trial (STOMP-II) of AVB-114 are expected in mid-2025.

The company has completed enrolment at 14 US sites in the Phase II clinical trial, and subjects who were randomised to AVB-114 or standard of care are being evaluated for combined clinical and radiological remission of the treated fistula.

William Faubion, Jr., M.D., Dean of Research at Mayo Clinic in Arizona, Medical Director of Mayo Clinic's Center for Regenerative Biotherapeutics, and a gastroenterologist who specializes in inflammatory bowel diseases, said: "Perianal fistulas are a tremendous challenge for patients and their treating physicians. If the results of the ongoing Phase II trial are consistent with the impact we saw in the Phase I trial, this treatment could transform the lives of Crohn's patients living with perianal fistulas."