New Hope for Crohn's: Avobis Bio's Implantable Therapy Shows High Efficacy

NEWARK, DE – January 29, 2026 – For thousands of individuals suffering from one of the most severe and painful complications of Crohn's disease, a new wave of optimism is building. Avobis Bio, a clinical-stage company, has announced expanded, positive results from its STOMP2 clinical trial, evaluating a novel implantable cell therapy, AVB-114, for the treatment of Crohn's perianal fistulas. The new data, which reinforces earlier positive findings, is set to be a highlight at the upcoming European Crohn's and Colitis Organisation (ECCO) Congress.

These fistulas—painful, tunneling wounds that create a connection between the rectum or anus and the skin—represent a significant unmet medical need, with current treatments failing to provide durable healing for an estimated two-thirds of patients. The latest findings from Avobis Bio not only bolster confidence in AVB-114's potential but also accelerate the company's journey towards a pivotal Phase 3 trial and, ultimately, commercialization.

A Breakthrough in Trial Results

The forthcoming presentation at the ECCO Congress on February 19th will feature an expanded analysis of the STOMP2 trial, delivered by Dr. David A. Schwartz of Vanderbilt University Medical Center, a lead investigator for the study. The significance of this new data lies in its source: patients from the trial's control arm, who were initially treated with the standard of care, were later given the option to receive AVB-114. Their outcomes have now been tracked and analyzed.

This unique 'wait-list controlled' design has effectively doubled the number of patients treated with AVB-114 in the analysis. According to Avobis Bio, this new cohort demonstrated effectiveness, safety, and tolerability profiles that were consistent with the original group of patients who received the therapy from the outset. This consistency across a larger patient set provides a much stronger statistical foundation for the therapy's benefits.

Dr. Schwartz commented on the significance of the expanded dataset in the company's announcement. "I am eager to present this expanded STOMP2 analysis at ECCO," he stated. "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."

Earlier results from the initial randomized portion of the Phase 2 trial were already compelling. The primary endpoint, measured at 9 months, showed a combined remission rate of 45.8% for patients treated with AVB-114. This stood in stark contrast to the 8.3% remission rate observed in the standard of care group, a statistically significant difference that underscores the potential of the investigational therapy. Remission was rigorously defined as the complete closure of the fistula's external opening with no drainage, confirmed by MRI scans showing no significant fluid collections. The therapy also demonstrated a favorable safety profile, with most adverse events being mild and related to the post-operative procedure.

The Science of Healing: What is AVB-114?

AVB-114 is not a conventional drug but a cutting-edge implantable cell therapy, positioning it as a unique approach in the clinical landscape. It is designed to directly address the impaired healing characteristic of Crohn's perianal fistulas. The treatment combines two key components: living mesenchymal stem cells and a plug-shaped, bioabsorbable material.

This composite implant is placed directly into the fistula tract. The bioabsorbable material acts as a scaffold, providing a physical structure to close the wound. Simultaneously, the living cells are believed to generate new tissue and release healing signals that modulate the local inflammatory environment. This dual-action mechanism aims to overcome the chronic inflammation and poor tissue regeneration that prevent fistulas from closing naturally or with conventional treatments.

This regenerative approach is a significant departure from the current standard of care, which often involves a frustrating cycle of antibiotics, immunosuppressive biologic drugs, and multiple surgical procedures. Surgical interventions frequently include the placement of a 'seton'—a surgical thread looped through the fistula to allow drainage and prevent abscesses—which can be a long-term, uncomfortable solution that does not result in healing.

A Fast Track to a Potential Cure

The promising clinical data is powerfully amplified by strong regulatory support from the U.S. Food and Drug Administration (FDA). AVB-114 was recently granted Regenerative Medicine Advanced Therapy (RMAT) designation, a program designed to expedite the development and review of therapies for serious or life-threatening conditions. This designation provides Avobis Bio with numerous advantages, including more intensive FDA guidance, senior management support, and potential flexibility in clinical trial design.

The RMAT designation, coupled with a recent face-to-face meeting with the FDA, has provided a clear and accelerated path forward. Avobis Bio is now channeling this momentum into its next critical steps: securing funding and preparing for a large-scale Phase 3 trial. A successful Phase 3 study is the final hurdle before the company can seek marketing approval for AVB-114.

"These latest trial results, along with FDA's recent in-person guidance, support our ongoing fundraising activities and phase 3 trial preparation," said Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio. "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."

For patients who live with the daily burden of pain, uncontrolled fecal drainage, and the constant risk of infection and sepsis, the prospect of a one-time, localized treatment that promotes durable healing is transformative. As the medical community awaits the full details of the expanded STOMP2 data at the upcoming congress, the progress of AVB-114 represents a significant beacon of hope and a potential paradigm shift in the management of a devastating condition.