Only implantable cell therapy for Crohn’s perianal fistulas with FDA IND clearance and Fast Track designation
Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AVB-114, the Company’s lead therapeutic candidate for Crohn’s perianal fistulas.
FDA 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. Compelling 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.
“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,” said William Faubion, Jr., M.D., Dean of Research at Mayo Clinic in Arizona, Medical Director of Mayo Clinic’s Center for Regenerative Biotherapeutics, and gastroenterologist who specializes in inflammatory bowel diseases.
The Phase II clinical trial has completed enrollment at 14 US sites and subjects who were randomized to AVB-114 or standard of care are being assessed for combined clinical and radiological remission of the treated fistula. More information on the study (NCT04847739) is available at www.clinicaltrials.gov.
“We are grateful for the FDA’s recognition that perianal fistulas are a serious condition for many patients living with Crohn’s disease and that AVB-114 has the potential to bring meaningful improvement to their lives,” said Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio. “Receiving Fast Track designation will enable us to work closely with FDA in reviewing the STOMP-II primary endpoint results later this year and aligning on the most expeditious commercialization pathway for AVB-114”.
Discover the latest trends and insights—explore the Business Insights Journal for up-to-date strategies and industry breakthroughs!
