Agomab's ALK5 Inhibitor Shows Promise in Phase 2 Crohn's Disease Trial

Agomab Therapeutics, a Belgian biotech company, has announced positive interim results from its phase 2 clinical trial of AGMB-129, an ALK5 inhibitor targeting fibrostenosing Crohn's disease. The STENOVA study, which enrolled 90 patients, has met its primary and secondary endpoints, marking a significant milestone in the development of novel treatments for this challenging form of inflammatory bowel disease.

Trial Design and Key Findings

The STENOVA study evaluated two doses of AGMB-129 against placebo over a 12-week period, with patients receiving the treatment in addition to standard care. The trial's primary endpoints focused on safety and tolerability, both of which were successfully met according to the interim analysis.

Secondary endpoints provided crucial insights into the drug's mechanism of action and potential efficacy:

• Changes in mRNA gene expression were observed in ileal biopsies, indicating that AGMB-129 successfully targeted the intended area of the small intestine affected by fibrostenosing Crohn's disease.
• Pharmacokinetic endpoints were achieved, as measured by metabolite levels in plasma.

While detailed results are being withheld for presentation at an upcoming scientific conference, Agomab's Chief Medical Officer, Philippe West, expressed optimism about the findings: "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."

Market Potential and Company Background

Fibrostenosing Crohn's disease represents a significant unmet medical need, affecting approximately 400,000 patients in the United States alone. Agomab's AGMB-129 aims to address this condition by potentially reducing scarring and inflammation when used in combination with existing Crohn's disease therapies.

Agomab, founded in 2019, built its scientific foundation on the research of Paolo Michieli, Ph.D., from the University of Torino, who has spent over two decades studying hepatocyte growth factor (HGF). The company expanded its portfolio in 2021 with the acquisition of Origo Biopharma, which brought AGMB-129 into its pipeline.

The development of AGMB-129 has been supported by substantial financial backing, including a $100 million Series C funding round completed in October 2023. This investment has enabled Agomab to advance the STENOVA trial and position itself as a potential leader in the treatment of fibrostenosing Crohn's disease.

Full results from the STENOVA study are expected in the fourth quarter of this year, which will provide a more comprehensive understanding of AGMB-129's efficacy and safety profile. As the pharmaceutical industry continues to seek innovative solutions for complex gastrointestinal disorders, Agomab's progress with AGMB-129 represents a promising development for patients and clinicians alike.