Avobis Bio Reports Positive Expanded STOMP2 Trial Results for Crohn's Perianal Fistula Cell Therapy
核心洞察
Avobis Bio (搜索) announced expanded primary analysis results from the STOMP2 trial showing AVB-114 demonstrated similar effectiveness through 9 months with favorable safety and tolerability in both randomized and control cohorts.
The all-treated AVB-114 sample size is nearly double that of the randomized set, providing greater confidence in the therapy's safety and efficacy profile for Crohn's perianal fistulas (搜索).
The company has met with the FDA to expedite development plans and is preparing for Phase 3 trials, targeting a condition where two out of three patients do not experience durable healing with current standard of care.
Avobis Bio (搜索) LLC has announced expanded primary analysis results from its STOMP2 clinical trial, demonstrating consistent efficacy and safety outcomes for AVB-114, an investigational implantable cell therapy for Crohn's perianal fistulas (搜索). The results will be presented at the European Crohn's and Colitis Organisation (搜索) (ECCO) Congress by Dr. David A. Schwartz from Vanderbilt University Medical Center.
Trial Results Show Consistent Efficacy Across Cohorts
The expanded analysis includes subjects who were initially randomized to control treatment and subsequently received AVB-114 after their primary endpoint visit. According to the company, both AVB-114 cohorts demonstrated similar effectiveness through 9 months with favorable safety and tolerability profiles.
Dr. Schwartz, who serves as Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition and Director of the Inflammatory Bowel Disease Center at Vanderbilt University Medical Center, commented on the significance of the expanded dataset. "The all-treated AVB-114 sample size is nearly double that of the randomized set, providing greater confidence in AVB-114's safety and efficacy profile in this severe complication of Crohn's disease (搜索)," he stated.
Regulatory Progress and Development Timeline
Avobis Bio (搜索) has engaged with the U.S. Food and Drug Administration through a face-to-face meeting focused on expediting the development plan for AVB-114. The therapy has previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, which provides intensive FDA guidance, senior management support, and clinical trial design flexibility.
Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio (搜索), emphasized the strategic importance of these developments. "These latest trial results, along with FDA's recent in-person guidance, support our ongoing fundraising activities and phase 3 trial preparation. We continue to advance towards the ultimate goal of offering an effective treatment for the many patients suffering with this severe and debilitating manifestation of Crohn's disease (搜索)."
Addressing Significant Unmet Medical Need
Perianal fistulas (搜索) represent a serious complication of Crohn's disease (搜索), characterized as painful tunneling wounds connecting the rectum or anus to the skin. The condition involves uncontrolled fecal drainage, pain, and constant risk of infection or sepsis. According to the company, an estimated two out of three patients do not experience durable fistula healing with current standard of care, resulting in prolonged suffering due to disease progression and multiple surgeries with complications.
Novel Therapeutic Approach
AVB-114 is described as the only clinical-stage implantable cell therapy specifically designed to address the impaired healing of Crohn's perianal fistulas (搜索). The treatment combines living cells with a plug-shaped bioabsorbable material to generate tissue and produce healing signals through local therapeutic delivery.
STOMP2 Trial Design
The STOMP2 study is a prospective, multicenter, randomized, wait-list controlled, open-label trial with blinded outcome assessment. The study enrolled patients with a single perianal fistula tract who had previously failed treatment with biologic or conventional Crohn's therapy or had documented medication intolerance.
The trial consisted of two parts, with Part 1 including randomization to either standard of care (fistula debridement and seton placement) or AVB-114 treatment, followed by Part 2 where control arm subjects could receive AVB-114 treatment. To ensure scientific rigor, the study employed a blinded core laboratory for MRI analysis and an independent data safety monitoring board for trial oversight.
The expanded results will be presented during Session A5 at the ECCO Congress on Thursday, February 19th at 6:27PM local time, providing the medical community with comprehensive data on this novel therapeutic approach for a challenging clinical condition.