#United States #Newark #Inflammatory Bowel Disease #Avobis Bio #AVB-114

Avobis Bio Achieves Key Milestone in Crohn's Treatment

Avobis Bio LLC, a clinical stage biotech company focused on implantable cell therapies, has recently completed the primary analysis of its STOMP-II clinical trial, aimed at evaluating AVB-114 for treating Crohn's perianal fistulas. This exciting development led the company to request the U.S. Food and Drug Administration (FDA) for the Regenerative Medicine Advanced Therapy (RMAT) designation for AVB-114, marking a significant step in clinical trial progress.

What is AVB-114?

AVB-114 stands as the unique clinical-stage implantable cell therapy designed to address the specific issues surrounding Crohn's disease perianal fistulas. This condition can be debilitating, resulting in uncontrolled fecal drainage, pain, and not infrequently leading to serious complications such as infections or sepsis. The innovative therapy combines living cells along with a bioabsorbable, plug-shaped material, which works synergistically to generate new tissue and promote healing signals in targeted areas, offering a new hope for patients who have exhausted conventional treatment options.

The positive results from the phase I STOMP-I clinical trial, where 76% of participants achieved clinical remission within a year following treatment, bolster confidence in AVB-114's potential effectiveness. The STOMP-II trial now places the therapy at the forefront of addressing this challenging medical issue, as many patients experience a lack of effective treatment options, with approximately two-thirds failing to achieve sustainable healing with current standards of care.

The Importance of RMAT Designation

RMAT designation serves as an important avenue for expediting the development process and regulatory review for therapies targeting serious health issues that have no effective cures. The designation allows for enhanced collaboration with the FDA, providing opportunities for frequent dialogue and discussions regarding potential surrogate endpoints or accelerated approval paths. With the follow-up of RMAT, Avobis aims to rapidly transition into phase III clinical trials, signaling a robust pipeline moving ahead swiftly.

Dr. David A Schwartz, a prominent investigator involved with STOMP-II and a Professor of Medicine at Vanderbilt University Medical Center, highlighted the critical nature of this research in his comments about the study outcomes. Schwartz stated, “We have struggled to find effective treatments for this serious manifestation of Crohn's disease. On behalf of the STOMP-II team, I’m enthusiastic to share these primary results with peers at upcoming conferences.”

The Future of AVB-114 and Avobis Bio

Positively resonating with its strategic development plan, Avobis Bio is gearing up for a late-breaking abstract submission at an esteemed gastroenterology conference, where they will unveil the comprehensive findings from their most recent analysis. These next steps will not only validate the initial successes but also facilitate ongoing discussions with potential investors as they seek to expand their funding avenues.

Avobis Bio is committed to transforming the landscape of treatments available for debilitating conditions through pioneering work in the field of implantable cell biology. As they embark on the next stages for AVB-114, they continue to underscore their goal of providing effective solutions and improved quality of life for patients battling chronic conditions.

As they push forward, the scientific and medical communities will be keenly watching for developments that may stem from this groundbreaking research, with the potential to redefine care pathways in managing Crohn's disease going forward. For continual updates and information regarding Avobis Bio and its cutting-edge therapeutic approaches, interested individuals can visit their website at avobisbio.com.