#USA #Newark #Crohn's Disease #Avobis Bio #AVB-114

Avobis Bio's Breakthrough in Treating Crohn’s Perianal Fistulas

Avobis Bio LLC recently presented promising data from their randomized multicenter STOMP2 clinical trial, focusing on the effectiveness of the implantable cell therapy AVB-114. This breakthrough was showcased during a plenary session at the American College of Gastroenterology's Annual Scientific Meeting, sparking interest and hope in the gastroenterology community. The results were detailed by Dr. David A. Schwartz, an esteemed investigator of the STOMP2 study and a professor at Vanderbilt University Medical Center.

The study involved 48 individuals suffering from Crohn's disease with persistent perianal fistulas, specifically patients who had not responded to existing biologic or conventional treatments. Participants were randomly assigned either to receive the Standard of Care (SoC) or AVB-114 treatment across 14 trial sites in the U.S. The primary endpoint required that patients achieve Combined Remission at the nine-month mark, based on MRI assessments indicating reduced fistula size and visible closure.

The results were compelling: Only 8.3% of the SoC group achieved remission compared to an impressive 45.8% of those treated with AVB-114, marking a 38% difference between the two groups and a statistically significant p-value of 0.0078. Additionally, there were no serious adverse events reported through the nine-month follow-up, showcasing a favorable safety profile for the new therapy.

Patient-reported outcomes also highlighted substantial improvements, with the Perianal Disease Activity Index (PDAI) scores decreasing from an average of 7.0 at baseline to 4.1 at nine months, indicating a shift from severe to minimal disease activity. Dr. Schwartz pointed out that the traditional approaches often fall short of achieving lasting remission, further emphasizing the need for innovative treatments like AVB-114.

Dr. Tiffany Brown, CEO of Avobis Bio, expressed gratitude to the trial’s participants and the medical professionals involved, noting that the positive outcomes reinforce the trajectory toward a Phase 3 clinical trial. The study results also played a key role in the U.S. Food and Drug Administration granting AVB-114 the Regenerative Medicine Advanced Therapy (RMAT) designation, a crucial step that allows for expedited development and clinical support as the company continues its mission to provide effective treatments for serious medical conditions.

Perianal fistulas present a significant challenge for patients with Crohn's disease, often leading to persistent pain, drainage issues, and a high risk of infection. The existing standard of care has proven inadequate for many, with around 66% of patients failing to attain durable healing. Avobis Bio aims to change this with its investigational therapy, which utilizes living cells combined with a bioabsorbable material to facilitate tissue regeneration and prompts healing signals in the targeted area.

The STOMP2 trial structure was robust, featuring randomized treatment alongside a wait-listed control group, added safety through independent evaluation of MRI results, and vigilant trial oversight to ensure data integrity. As Avobis Bio moves closer to its goal of introducing AVB-114 into the clinical market, they remain committed to enhancing the quality of life for those suffering from debilitating conditions.

For ongoing details on the trial, follow updates at ClinicalTrials.gov.

Conclusion

The positive findings from the STOMP2 clinical trial signify a hopeful advancement in the management of Crohn's perianal fistulas, underscoring Avobis Bio's dedication to harnessing biomedicine for transformative healing solutions in gastroenterology.