Avobis Bio LLC, a US-based clinical stage company developing implantable cell therapies, announced Friday 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 on 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 help address development to address this serious unmet need.

Preliminary clinical evidence is required for investigational regenerative medicines to receive RMAT designation. According to Avobis Bio, its phase I clinical trial (STOMP-I) demonstrated 76% 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 29 October 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 Center at Vanderbilt University Medical Center.

Avobis Bio said that results from the phase II primary analysis are the latest milestone in its implantable cell therapy pipeline and provide new data to share in ongoing fundraising activities.