Avobis Bio Seeks FDA Fast-Track Status for Implantable Cell Therapy Following Positive Crohn's Fistula Trial
Key Insights
Avobis Bio (search) completed primary analysis of the STOMP-II phase II trial for AVB-114, an implantable cell therapy targeting Crohn's perianal fistulas (search), and submitted a request for FDA RMAT designation.
The company plans to leverage both RMAT designation and existing Fast Track status to expedite a phase III trial, addressing a condition where two-thirds of patients fail to achieve durable healing with current treatments.
AVB-114 represents the only clinical-stage implantable cell therapy for this indication, having previously demonstrated 76% clinical remission at 12 months in the phase I STOMP-I trial.
Avobis Bio (search) LLC announced completion of primary analysis for its STOMP-II phase II clinical trial of AVB-114, an implantable cell therapy for Crohn's perianal fistulas (search), leading to a submission for FDA Regenerative Medicine Advanced Therapy (RMAT) designation. The multicenter, randomized trial results prompted the clinical-stage company to seek expedited regulatory pathways for this novel therapeutic approach targeting a debilitating manifestation of Crohn's disease (search).
Regulatory Strategy and Trial Advancement
The company filed its RMAT designation request based on the STOMP-II primary analysis results, building upon AVB-114's existing Fast Track Designation. RMAT designation provides significant regulatory advantages, including frequent FDA interactions, discussion of potential surrogate endpoints, and pathways to accelerated approval for regenerative medicine therapies addressing serious medical conditions.
Following potential RMAT designation, Avobis Bio (search) intends to immediately engage with the FDA to expedite initiation of a phase III trial. The primary analysis results will be presented as a late-breaking abstract at an upcoming preeminent gastroenterology conference, providing the medical community with new data on this investigational therapy.
Addressing Unmet Medical Need
Perianal fistulas (search) represent a serious complication of Crohn's disease (search), characterized by painful tunneling wounds connecting the rectum or anus to the skin. These conditions cause uncontrolled fecal drainage, pain, and constant risk of infection or sepsis. Current treatment outcomes remain suboptimal, with an estimated two out of three patients failing to experience durable fistula healing with standard of care approaches, resulting in prolonged suffering, disease progression, and multiple surgeries with complications.
Dr. David A. Schwartz, a STOMP-II investigator and Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition at Vanderbilt University Medical Center, emphasized the clinical challenge: "We have struggled to find effective treatments for this serious manifestation of Crohn's disease (search). On behalf of the STOMP-II investigators, I'm excited to share the primary analysis results of this rigorous trial with my peers."
Novel Therapeutic Approach
AVB-114 represents the only clinical-stage implantable cell therapy specifically designed to address the impaired healing characteristic of Crohn's perianal fistulas (search). The therapy combines living cells with a plug-shaped bioabsorbable material to generate tissue and produce healing signals through localized treatment.
The therapeutic approach builds on promising phase I results from the STOMP-I clinical trial, which demonstrated 76% clinical remission in patients with persistent perianal Crohn's disease (search) at 12 months post-treatment. This efficacy signal provided the foundation for advancing to the randomized phase II STOMP-II trial.
Development Pipeline Impact
The STOMP-II primary analysis results represent the latest milestone in Avobis Bio (search)'s implantable cell therapy pipeline and provide new data supporting ongoing fundraising activities. The company's mission focuses on transforming treatment for patients with debilitating conditions by harnessing implantable biology to develop curative therapies for tissue healing.
AVB-114 remains an investigational drug limited to investigational use under United States law, with safety and effectiveness not yet established and no commercial availability in any markets.