Avobis Bio’s AVB-114 Receives FDA RMAT Designation for Crohn’s Perianal Fistulas

Avobis Bio’s AVB-114 Receives FDA RMAT Designation for Crohn’s Perianal Fistulas

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!