Agomab announces positive phase 2a interim results for AGMB-129

FSCD therapy meets all endpoints in interim analysis

Agomab Therapeutics NV (Agomab) has announced positive interim results from 44 patients completing treatment in the ongoing STENOVA phase 2a clinical trial for AGMB-129.

AGMB-129 is an oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 for the potential treatment of fibrostenosing Crohn’s disease (FSCD).

STENOVA is a randomized, double-blind, placebo-controlled study in 90 patients with symptomatic FSCD. Patients receive one of two doses of AGMB-129 or placebo for 12 weeks on top of standard care, including biologics. The multi-center study is global, with investigational sites in the US, Canada, and Europe.

The primary endpoints are the safety and tolerability of AGMB-129 in FSCD patients. Secondary endpoints include the pharmacokinetics and target engagement at the site of the ileal strictures as measured through transcriptomics. All primary and secondary endpoints were met.

The company has also initiated the open-label treatment extension of the STENOVA study with AGMB-129. Study participants who have completed the double-blind 12-week treatment period are eligible to participate and can receive treatment for up to an additional 48 weeks.

Philippe Wiesel, Chief Medical Officer at Agomab Therapeutics, said: “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. 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.”

AGMB-129 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.

Fibrostenosing complications occur in nearly 50% of Crohn’s disease patients and are the leading cause of bowel resection surgery. AGMB-129 has received US FDA Fast Track Designation.