FDA Grants Fast Track Status to AVB-114, Novel Cell Therapy for Crohn's Perianal Fistulas
Key Insights
Avobis Bio (search)'s AVB-114, the only FDA-cleared implantable cell therapy for Crohn's perianal fistulas (search), receives Fast Track designation to expedite development and review process.
Phase II clinical trial (STOMP-II) has completed enrollment across 14 US sites, with primary endpoint results expected in mid-2025.
Initial compelling results from Mayo Clinic's Phase I trial (STOMP-I) led to Avobis Bio (search)'s founding and shows promise for transforming treatment of perianal fistulas (search) in Crohn's patients.
Avobis Bio (search) LLC announced today that its lead therapeutic candidate AVB-114 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of Crohn's perianal fistulas (search). This designation marks a significant milestone as AVB-114 becomes the only implantable cell therapy for this condition to hold both FDA IND clearance and Fast Track status.
The FDA's Fast Track program is designed to accelerate the development and review process for medications that address serious conditions with significant unmet medical needs. This designation will allow Avobis Bio (search) to maintain closer communication with the FDA and potentially benefit from expedited review processes, including rolling submission and priority review opportunities.
Clinical Development Progress
The company's ongoing Phase II trial, known as STOMP-II, has successfully completed enrollment at 14 clinical sites across the United States. The study is evaluating AVB-114 against standard of care, with primary endpoints focusing on combined clinical and radiological remission of treated fistulas. Results from this pivotal trial are anticipated in mid-2025.
William Faubion, Jr., M.D., Dean of Research at Mayo Clinic in Arizona and Medical Director of Mayo Clinic's Center for Regenerative Biotherapeutics, expressed optimism about the therapy's potential: "Perianal fistulas (search) 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."
Therapeutic Impact and Development Strategy
The development of AVB-114 stems from promising results observed in the Phase I STOMP-I trial conducted at Mayo Clinic, which led to the formation of Avobis Bio (search). The therapy represents a novel approach to addressing the significant unmet need in treating perianal fistulas (search), a debilitating complication of Crohn's disease (search).
"We are grateful for the FDA's recognition that perianal fistulas (search) are a serious condition for many patients living with Crohn's disease (search) and that AVB-114 has the potential to bring meaningful improvement to their lives," said Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio (search). She added that the Fast Track designation will facilitate closer collaboration with the FDA in reviewing the STOMP-II primary endpoint results and determining the most efficient path to commercialization.
Clinical Trial Details
The Phase II STOMP-II trial (NCT04847739) is currently ongoing, with detailed information available through the ClinicalTrials.gov database. The study's design focuses on evaluating the efficacy of AVB-114 compared to current standard of care treatments, with particular attention to achieving both clinical and radiological remission in treated fistulas.