FDA Grants Fast Track to Avobis Bio's AVB-114 for Crohn's Perianal Fistulas

Avobis Bio LLC, a clinical-stage company based in Newark, Delaware, has announced a significant milestone in the development of its innovative treatment for Crohn's disease-associated perianal fistulas. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AVB-114, the lead therapeutic candidate of Avobis Bio. This designation is granted to expedite the development and review of drugs that show potential to address unmet medical needs in serious conditions, and it underscores the promise AVB-114 holds for improving the lives of patients afflicted with this challenging disease.

The Fast Track designation was awarded based on encouraging results from early clinical trials. A Phase I trial conducted by the Mayo Clinic, known as "STOMP-I," demonstrated significant promise, leading to the establishment of Avobis Bio. Currently, AVB-114 is undergoing a Phase II trial, dubbed "STOMP-II," with primary endpoint results anticipated in mid-2025. This trial has completed enrollment at 14 sites across the United States, and participants are being evaluated for both clinical and radiological remission of the treated fistulas.

William Faubion, Jr., M.D., a key figure in the development of this treatment at the Mayo Clinic, emphasized the potential impact of AVB-114. He noted the significant challenge perianal fistulas pose for patients and healthcare providers and expressed hope that the ongoing trial results will mirror the positive outcomes observed in the initial phase. If successful, this could be transformative for Crohn's patients suffering from this debilitating condition.

Perianal fistulas are painful and complex tunneling wounds that connect the rectum or anus to the skin, often resulting in uncontrolled fecal drainage, pain, and a high risk of infection. Current treatments fail to provide lasting relief for approximately two-thirds of patients, leading to prolonged suffering and frequent surgical interventions. AVB-114 offers a novel approach by utilizing living cells and a plug-shaped bioabsorbable material to promote tissue regeneration and healing in the affected area.

Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio, expressed her appreciation for the FDA's recognition of the severity of perianal fistulas and the potential of AVB-114 to effect meaningful change in patients' lives. The Fast Track designation will facilitate closer collaboration with the FDA, allowing for an expedited review process once the STOMP-II trial results are available later this year, paving the way for potential commercialization.

The Fast Track process is a crucial FDA initiative designed to accelerate the development of treatments for serious conditions with unmet medical needs. It offers benefits such as more frequent interactions with the FDA, rolling submission of marketing applications, priority review, and potential accelerated approval.

AVB-114 remains an investigational therapy, and while it has shown promise in early trials, its safety and efficacy are not yet established, and it is not available for commercial use. However, the advancements made by Avobis Bio reflect a significant step forward in addressing the critical needs of Crohn's patients with perianal fistulas, offering hope for improved treatment outcomes in the near future.