#USA #Newark #Avobis Bio #AVB-114 #STOMP2

New Insights from Avobis Bio at the ECCO Congress

On January 29, 2026, Avobis Bio LLC, a company focusing on implantable cell therapies, announced expanded findings from the STOMP2 clinical trial. This update precedes an oral presentation scheduled at the European Crohn's and Colitis Organisation (ECCO) Congress. Dr. David A. Schwartz, a key investigator in the STOMP2 trial and the Director of the Inflammatory Bowel Disease Center at Vanderbilt University Medical Center, will reveal these results during Session A5, which will take place on February 19 at 6:27 PM local time.

The STOMP2 trial aims to address a significant complication of Crohn's disease: perianal fistulas, which can severely affect patients’ quality of life. In the latest update, the data from the new cohort indicated outcomes that are both favorable and consistent with previously reported results from the randomized group. Dr. Schwartz previously presented the primary endpoint findings, focusing on subjects who received AVB-114 treatment. Now, he will include results from subjects who, after initially being assigned to control treatment, were later treated with AVB-114 post the primary endpoint assessment. Both sets of patients demonstrated comparable effectiveness in healing over a period of nine months and displayed an acceptable safety profile.

Dr. Schwartz expressed his enthusiasm for sharing the additional analysis results: “The expanded sample size of patients treated with AVB-114 nearly doubles the original randomized group. This increase provides us with enhanced confidence in AVB-114’s safety and efficacy for managing this severe complication of Crohn's disease.”

In a bid to expedite the progression of AVB-114, Avobis recently engaged in a constructive dialogue with the U.S. Food and Drug Administration (FDA). Discussions centered on advancing the development strategy for this innovative treatment. Tiffany Brown, PhD, CEO of Avobis Bio emphasized the importance of aligning the latest findings with FDA guidance: “These trial outcomes, along with the FDA’s in-person recommendations, will support our continued fundraising initiatives and preparations for Phase 3 trials. We are steadfast in our mission to provide an effective solution for patients grappling with this debilitating manifestation of Crohn's disease.”

Understanding Crohn's Perianal Fistulas

Perianal fistulas are notably challenging conditions characterized by painful tunnels connecting the anal area to the skin, often leading to issues like fecal drainage, pain, and an increased risk of severe infections such as sepsis. Approximately two-thirds of patients with this condition do not achieve long-lasting healing with current standard treatments, causing prolonged suffering and necessitating multiple surgeries, which can lead to even more complications.

About AVB-114

AVB-114 is an investigational implantable cell therapy designed to rectify the impaired healing process associated with perianal fistulas in Crohn's disease patients. The therapy combines live cells with a bioabsorbable material in a plug shape, aiming to promote tissue generation and enhance healing signals at the treatment site. Notably, the FDA has granted AVB-114 the Regenerative Medicine Advanced Therapy (RMAT) designation, which offers benefits including increased FDA oversight, management support, and clinical trial design flexibility aimed at hastening development in light of the severe unmet need this therapy seeks to address.

About STOMP2

The STOMP2 study is a randomized, multicenter, wait-list controlled phase 2 study. It includes participants with a perianal fistula tract that has previously failed to respond to standard Crohn's treatments. This phase is essential as it assesses therapies designed to alleviate persistent, painful symptoms and enhance patient outcomes. Participants are also followed longitudinally to gauge treatment efficacy and safety over an extended period.

In conclusion, Avobis Bio's ongoing research underscores a strong commitment to advancing innovative treatments for Crohn's disease, with the hope of improving outcomes for those suffering from its most severe manifestations. For detailed study information, please refer to ClinicalTrials.gov or visit avobisbio.com.