Agomab Reveals NOV-ERA Phase 2b Design for Crohn's Disease

Antwerp, Belgium. Agomab Therapeutics NV (Nasdaq: AGMB), a clinical-stage biopharmaceutical company specializing in fibro-inflammatory diseases, has announced the successful alignment with the U.S. Food and Drug Administration (FDA) regarding the design of its upcoming Phase 2b clinical trial, known as the NOV-ERA study. This trial aims to evaluate the efficacy and safety of ontunisertib, an oral, gastro-intestinal-restricted ALK5 inhibitor, as a potential treatment for Fibrostenosing Crohn's Disease (FSCD).

FSCD affects approximately 46% of patients with Crohn's disease, manifesting as fibrotic strictures that cause significant obstructive symptoms, malnutrition, and a high reliance on surgical intervention. Currently, there are no approved pharmacological treatments for this condition. Agomab's trial design has been cleared by the FDA and has already received approval from Health Canada, with Clinical Trial Applications submitted in other global jurisdictions.

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