Avobis Bio Presents Positive Primary Analysis Results from the Randomized Multicenter STOMP2 Clinical Trial at a Plenary Session of the American College of Gastroenterology’s Annual Scientific Meeting

The Implantable Cell Therapy AVB-114 Demonstrated Favorable Safety and Effectiveness in the Phase II Trial for Crohn’s Perianal Fistulas –

Excerpt from the Press Release:

NEWARK, Del., Oct. 29, 2025 /PRNewswire/ — Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced that the STOMP2 primary analysis results were revealed today at a plenary session of the American College of Gastroenterology’s Annual Scientific Meeting. The trial results were accepted as a late-breaking abstract and presented by Dr David A Schwartz, a STOMP2 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.

A total of 48 subjects with Crohn’s disease and a persistent perianal fistula with failed response or documented medication intolerance to biologic or conventional treatment were randomized 1-to-1 to Standard of Care (“SoC”) or AVB-114 treatment at 14 U.S. trial sites. To meet the effectiveness primary endpoint of Combined Remission at 9 months, there could be no collections >2cm in at least two of the three dimensions on the MRI (assessed by blinded core lab), the external opening must appear visually closed, and no drainage of fluid despite gentle finger compression. Combined remission was 8.3% (2/24) for SoC and 45.8% (11/24) for AVB-114 (38% difference, 95% confidence interval 11 – 60%, post hoc p-value = 0.0078).

Click the button below to read the entire Press Release:

Continue Reading The Press Release