Analysis leads to FDA RMAT submission and late-breaking abstract for implantable cell therapy -

Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced today that primary analysis of the STOMP-II clinical trial led to a request to the U.S. Food and Drug Administration ("FDA") for Regenerative Medicine Advanced Therapy ("RMAT") designation for AVB-114, the Company's lead therapeutic candidate for Crohn's perianal fistulas.

Avobis Bio completed the primary prospective analysis of the multicenter, randomized phase II trial ("STOMP-II") and subsequently filed a request for RMAT designation based on the results. Intended to expedite development and review of therapies addressing serious medical conditions, RMAT designation provides benefits including frequent FDA interactions and discussion of potential surrogate endpoints or accelerated approval. Following RMAT designation and building upon its existing Fast Track Designation for AVB-114, Avobis Bio intends to immediately engage FDA to expedite a phase III trial. 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.

The primary analysis results will be submitted as a late-breaking abstract to an upcoming preeminent gastroenterology conference. Dr David A 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, commented that "We have struggled to find effective treatments for this serious manifestation of Crohn's disease. On behalf of the STOMP-II investigators, I'm excited to share the primary analysis results of this rigorous trial with my peers."