Positive top-line Phase IIa data for Agomab’s ontunisertib

Belgium-based Agomab Therapeutics today announced positive data from 103 participants completing 12 weeks of treatment in the STENOVA Phase IIa clinical trial for ontunisertib (AGMB-129), an investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (TGF-b RI or ALK5) for the potential treatment of fibrostenosing Crohn’s disease (FSCD).

The primary endpoint is the evaluation of the safety and tolerability of ontunisertib in FSCD patients. Secondary endpoints include pharmacokinetics (PK) and target engagement as measured through transcriptomics in mucosal biopsies. Exploratory endpoints include the Simple Endoscopic Score of Crohn’s disease (SES-CD) and novel FSCD specific endpoints such as the Stricturing Patient Reported Outcome (S-PRO) score and Magnetic Resonance Enterography (MRE).

While an exact figure for the fibrostenosing component is unavailable, it is a significant subset, as around one-third of Crohn's patients may develop fistulas, a common complication of fibrosis. The overall Crohn's disease market is projected to grow, with forecasts suggesting it will reach $13.20 billion in 2030.