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news.The US Food and Drug Administration (FDA) has granted fast track designation for Avobis Bio’s lead therapeutic candidate, AVB-114, for treating Crohn's perianal fistulas.
The designation is designed to accelerate the development and review of medications that show potential to address serious conditions. Credit: Louis Reed on Unsplash.
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The designation is designed to accelerate the development and review of medications that show potential to address serious conditions.
Candidates with this designation may qualify for an interaction with the agency, marketing applications submission filing, accelerated approval as well as priority review.
Mayo Clinic’s Phase I trial outcomes paved the way for the company’s founding, with primary endpoint outcomes from the Phase II trial of AVB-114 anticipated in the middle of this year.
The Phase I STOMP-I trial showed outcomes, with 76% of subjects experiencing clinical healing and a ten-fold decrease in the number of annualised exams under anaesthesia one year after treatment, in individuals with persistent refractory perianal Crohn’s disease.
Enrolment for the Phase II trial has been completed across 14 sites in the US, with subjects randomised to either the therapy or standard of care.
These participants are currently being evaluated for combined clinical and radiological remission of the fistula that is treated.
Avobis Bio CEO Tiffany Brown said: “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.
“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 commercialisation pathway for AVB-114.”
An implantable cell therapy, AVB-114 is designed to address the impaired healing of Crohn’s perianal fistulas.
Perianal fistulas are described as “painful” wounds that form between the rectum or anus and the skin.
This causes uncontrolled faecal drainage, and constant infection or sepsis risk.
