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.
