Avobis Bio Seeks RMAT Designation for AVB-114 After Positive Phase II Trial Results

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

Phase II Trial and RMAT Request

• Trial: STOMP-II – multicenter, randomized, Phase II
• Therapy Candidate: AVB-114 – implantable cell therapy for Crohn’s perianal fistulas
• Outcome: Primary prospective analysis completed, leading to RMAT designation request

RMAT designation benefits include:

• Frequent and early FDA interactions
• Discussions on potential surrogate endpoints
• Opportunity for accelerated approval pathways

Avobis Bio already holds Fast Track Designation for AVB-114. Following RMAT approval, the company plans to:

• Immediately engage with the FDA
• Expedite Phase III trial initiation
• Use results to support fundraising activities

The primary analysis results will be submitted as a late-breaking abstract to a major gastroenterology conference.

Expert Commentary

“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.”

• Dr. David A. Schwartz, STOMP-II Investigator, Professor of Medicine, Vanderbilt University Medical Center

Understanding RMAT Designation

What is RMAT?
A special FDA process that:

• Facilitates development and review of regenerative medicine therapies
• Applies to treatments addressing serious or life-threatening conditions
• Requires clinical evidence of potential to address unmet medical needs

Key benefits of RMAT status:

• Early and prioritized FDA meetings
• Potential for accelerated approval
• Flexibility to use surrogate or intermediate trial endpoints

About Crohn’s Perianal Fistulas

• Definition: Painful, tunneling wounds connecting the rectum or anus to the skin
• Complications:
  - Uncontrolled fecal drainage
  - Chronic pain
  - High risk of infection or sepsis
• Treatment Challenges:
  - 2 out of 3 patients do not achieve durable healing with current treatments
  - Often require multiple surgeries with risk of complications

About AVB-114

• Type: Clinical-stage implantable cell therapy
• Goal: Overcome impaired healing in Crohn's perianal fistulas
• Mechanism: Combines living cells with a plug-shaped bioabsorbable material to:
  - Promote tissue regeneration
  - Deliver healing signals locally

Previous trial data (STOMP-I Phase I):

• 76% clinical remission after 12 months in patients with persistent perianal Crohn’s disease

Note: AVB-114 is investigational — safety and efficacy have not been established, and it is not yet commercially available.

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