Avobis Bio has announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for AVB-114, the company's lead therapeutic candidate for Crohn's perianal fistulas. Building upon its existing Fast Track Designation for AVB-114, RMAT designation provides additional benefits including intensive FDA guidance, senior management support, and clinical trial design flexibility to thereby expedite development to address this serious unmet need.

Investigational regenerative medicines must possess preliminary clinical evidence to receive RMAT designation. The phase I clinical trial (STOMP-I) demonstrated 76 percent drainage cessation in patients with persistent perianal Crohn's disease, 12 months after treatment. Additionally, primary analysis of the follow-on randomised multicentre phase-II trial (STOMP-II) was recently completed. Results will be presented at the American College of Gastroenterology's 2025 Annual Scientific Meeting at Plenary Session 4B:IBD on Wednesday October 29, 2025 by Dr David Schwartz, a STOMP-II investigator, Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition, and Department of Medicine, and Director of the Inflammatory Bowel Disease Centre at Vanderbilt University Medical Centre.

Results from the phase-II primary analysis are the latest milestone in Avobis Bio's implantable cell therapy pipeline and provide new data to share in ongoing fundraising activities.

"We are encouraged by the FDA's affirmation that the STOMP clinical dataset demonstrates AVB-114's potential to meaningfully improve outcomes for Crohn's disease patients with perianal fistulas–a serious condition lacking effective treatments. Avobis looks forward to collaborating with FDA under RMAT designation to expedite a phase-III trial and achieve our goal of reaching patients in need," said Tiffany Brown, PhD, Chief Executive Officer, Avobis Bio.