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

NEWARK, Del., Aug. 7, 2025 /PRNewswire/ -- 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."

About Regenerative Medicine Advanced Therapy (RMAT) Designation

RMAT is a process designed by the FDA to facilitate the development and expedite the review of investigational regenerative medicine therapies that have clinical evidence indicating their potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with RMAT designation possess numerous benefits including early, frequent, and prioritized interactions with FDA to expedite product development such as potential surrogate or intermediate trial endpoints or accelerated approval.

About Crohn's Perianal Fistulas

Perianal fistulas are painful tunneling wounds connecting the rectum or anus to the skin. The condition is serious as there is uncontrolled fecal drainage, pain and the constant risk of infection or sepsis. An estimated 2 out of 3 patients do not experience durable fistula healing with the current standard of care, resulting in elevated and prolonged suffering due to disease progression and multiple surgeries with complications.

About AVB-114

AVB-114 is the only clinical-stage implantable cell therapy aiming to overcome the impaired healing of Crohn's perianal fistulas. Living cells and a plug-shaped bioabsorbable material combine to generate tissue and produce healing signals in a local therapeutic treatment. The phase I STOMP-I clinical trial demonstrated 76% clinical remission in patients with persistent perianal Crohn's disease 12 months after treatment. AVB-114 is an investigational drug and limited by United States law to investigational use. Its safety and effectiveness has not been established, and it is not commercially available in any markets.

About Avobis Bio

Avobis Bio's mission is to transform life for patients with debilitating conditions by harnessing the power of implantable biology to develop curative therapies for healing tissues. For more information, please visit avobisbio.com.

Avobis Bio Media Contact:

Tiffany Brown, PhD

Chief Executive Officer

info@avobisbio.com

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SOURCE Avobis Bio