Agomab Therapeutics has announced positive interim results from its ongoing STENOVA Phase 2a clinical trial evaluating AGMB-129 for the treatment of fibrostenosing Crohn's disease (FSCD). The data, collected from 44 patients who completed the 12-week treatment period, showed that the investigational drug met all primary and secondary endpoints.
STENOVA is a randomized, double-blind, placebo-controlled study involving 90 patients with symptomatic FSCD across multiple centers in the United States, Canada, and Europe. Participants received one of two doses of AGMB-129 or placebo in addition to their standard care regimens, which included biologics.
The primary endpoints focused on safety and tolerability of AGMB-129 in FSCD patients, while secondary endpoints examined pharmacokinetics and target engagement at ileal stricture sites through transcriptomic analysis. According to the company, all these endpoints were successfully achieved.
Novel Mechanism Targets Intestinal Fibrosis
AGMB-129 represents a novel approach to treating FSCD, a condition characterized by intestinal narrowing due to fibrosis. The drug is an oral, small molecule inhibitor of ALK5 (TGF-β RI) that is specifically designed to work locally in the gastrointestinal tract.
What distinguishes AGMB-129 from other TGF-β inhibitors is its GI-restricted mechanism. The drug undergoes rapid first-pass metabolism in the liver, preventing clinically relevant systemic exposure while maintaining high local concentrations in the ileum. This approach potentially offers an improved safety profile compared to systemically available inhibitors in this class.
Philippe Wiesel, Chief Medical Officer at Agomab Therapeutics, commented on the significance of these results: "The positive interim data for the STENOVA Phase 2a clinical trial represent a significant milestone for this program, and we look forward to presenting the detailed results at a scientific conference in the near-term."
Addressing a Significant Unmet Need
Fibrostenosing complications occur in nearly 50% of Crohn's disease patients and represent the leading cause of bowel resection surgery. Currently, there are no approved specific therapies for FSCD, highlighting the substantial unmet medical need in this area.
The U.S. Food and Drug Administration has recognized this need by granting Fast Track Designation to AGMB-129, potentially expediting its development and review process.
Continued Development and Next Steps
Following these positive interim results, Agomab has initiated an open-label extension study of AGMB-129. Patients who completed the initial 12-week double-blind treatment period are eligible to participate and may receive treatment for up to an additional 48 weeks.
The full results from the STENOVA trial are expected in the fourth quarter of 2025. Detailed interim results will be presented at an upcoming scientific conference, according to the company.
Phase 1 Results Support Development Strategy
Earlier Phase 1 trials in healthy subjects showed that AGMB-129 was generally well-tolerated at all doses tested. These studies confirmed high local exposure to the drug in the ileum without clinically relevant systemic exposure, validating the GI-restricted mechanism.
Dr. Wiesel acknowledged the contributions of study participants: "We want to thank all patients and investigators for participating in this trailblazing study, which aims to address the high unmet medical need that exists in the field of fibrostenosing Crohn's disease."
About Agomab Therapeutics
Agomab is focused on achieving disease modification by modulating inflammation and fibrosis in chronic conditions such as Fibrostenosing Crohn's Disease and Idiopathic Pulmonary Fibrosis. The company targets biologically validated pathways, including Transforming Growth Factor β, and applies specialized capabilities in developing organ-restricted small molecules.
With AGMB-129 still being an investigational drug not yet approved by any regulatory authority, its full efficacy and safety profile remains to be established through continued clinical development.
