Avobis Bio LLC, a clinical-stage company developing implantable cell therapies, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its lead candidate, AVB-114, targeting Crohn’s perianal fistulas.
Building on its existing Fast Track designation, RMAT status provides additional benefits including:
- Intensive FDA guidance
- Senior management support
- Clinical trial design flexibility
These incentives aim to expedite development and bring new solutions to a condition with high unmet medical need.
Clinical Evidence Supporting RMAT
To qualify for RMAT, investigational therapies must show preliminary clinical evidence of meaningful benefit. AVB-114 has demonstrated promising results:
- Phase I trial (STOMP-I): 76% of patients achieved drainage cessation 12 months after treatment
- Phase II trial (STOMP-II): Primary analysis recently completed; results will be presented at the American College of Gastroenterology 2025 Annual Scientific Meeting on October 29, 2025
“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.”
- Tiffany Brown, PhD, CEO of Avobis Bio.
About Crohn’s Peri2anal Fistulas
Perianal fistulas are painful tunnels connecting the rectum or anus to the skin, often causing:
- Uncontrolled fecal drainage
- Severe pain
- High risk of infection or sepsis
Current standard-of-care treatments fail to achieve durable healing in approximately two-thirds of patients, leading to repeated surgeries and prolonged suffering.
About AVB-114
AVB-114 is an implantable cell therapy designed to promote local tissue regeneration and healing signals at the fistula site. It combines living cells with a bioabsorbable plug-shaped material to restore tissue integrity.
AVB-114 is currently investigational and not commercially available. Its safety and efficacy have not been established.
About RMAT Designation
The FDA’s RMAT program accelerates the development and review of regenerative medicine therapies that show potential to address serious or life-threatening conditions. Benefits include:
- Early and frequent interactions with the FDA
- Opportunities for surrogate or intermediate trial endpoints
- Potential eligibility for accelerated approval
About Avobis Bio
Avobis Bio focuses on transforming care for patients with debilitating conditions through implantable biology and curative tissue therapies.
