Agomab Reports Positive Phase 2a Interim Results for AGMB-129 in Crohn's Disease

Agomab Therapeutics NV recently shared promising interim results from the STENOVA Phase 2a clinical trial involving the drug AGMB-129. This trial, which assessed the drug's potential in treating Fibrostenosing Crohn’s Disease (FSCD), included 44 patients who completed a 12-week treatment regimen. AGMB-129 is a novel oral small molecule designed to inhibit ALK5 (TGF-β RI) specifically within the gastrointestinal tract. Its development is driven by the need to address fibrosis, a condition that significantly impacts patients with Crohn’s disease.

The STENOVA study is structured as a randomized, double-blind, placebo-controlled trial with a target enrollment of 90 patients displaying symptoms of FSCD. Participants were randomly assigned to receive either one of two doses of AGMB-129 or a placebo alongside their standard treatment, which could include biologics. This global study is conducted across multiple sites in the USA, Canada, and Europe. The trial’s primary endpoints focus on the safety and tolerability of AGMB-129 in FSCD patients, while secondary endpoints assess pharmacokinetics and target engagement in ileal strictures using transcriptomics. In this interim analysis, the study successfully met all its primary and secondary endpoints.

Following these promising interim findings, Agomab has launched an open-label extension of the STENOVA study, permitting participants who completed the initial 12 weeks to continue receiving AGMB-129 for an additional 48 weeks. Philippe Wiesel, Agomab’s Chief Medical Officer, expressed enthusiasm about these interim results, highlighting them as a vital step forward. He expressed gratitude to the patients and investigators involved, acknowledging their role in advancing treatment options for a condition with limited therapeutic solutions.

AGMB-129 remains an investigational drug and is yet to receive regulatory approval. Its safety and efficacy are not fully established. However, its development is guided by a unique mechanism designed to confine its action to the gastrointestinal tract. This design aims to prevent significant systemic exposure, potentially offering an enhanced safety profile compared to other inhibitors in this category. Initial Phase 1 trials in healthy individuals demonstrated that AGMB-129 was generally well-tolerated and achieved high local concentrations in the ileum without significant systemic distribution, underscoring the drug's targeted approach.

Fibrosis in Crohn’s disease is a major concern, with nearly half of all patients developing fibrostenosing complications. These complications frequently lead to bowel resection surgeries, and currently, there are no approved specific treatments available for FSCD. Recognizing this critical gap, AGMB-129 has been granted Fast Track Designation by the U.S. FDA, reflecting the urgent need for innovative therapies in this area.

Agomab Therapeutics is dedicated to transforming the treatment landscape for chronic conditions characterized by inflammation and fibrosis, such as Fibrostenosing Crohn’s Disease and Idiopathic Pulmonary Fibrosis. By focusing on biologically validated pathways like Transforming Growth Factor β, and leveraging their expertise in organ-specific small molecules, Agomab aims to pioneer disease-modifying therapies. With a robust clinical pipeline, comprehensive research and development capabilities, and strong investor support, Agomab is poised to make substantial strides in improving patient outcomes in fibrotic disorders.