- Designation sets the stage for intensive phase III trial planning with FDA -

NEWARK, Del., Oct. 3, 2025 /PRNewswire/ -- Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced today that the U.S. 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% drainage cessation in patients with persistent perianal Crohn's disease, 12 months after treatment. Additionally, primary analysis of the follow-on randomized multicenter 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 Center at Vanderbilt University Medical Center. 

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," said Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio. "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".

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. 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