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AgomAb reports positive Phase 2a data for ontunisertib in Crohn's, plans global NOV-ERA trial with 320 patients
AGMBAgomAb Therapeutics NV
AgomAb Therapeutics NV reported positive topline data from the Open-Label Extension (OLE) portion of its Phase 2a STENOVA trial evaluating ontunisertib in patients with fibrostenosing Crohn’s disease. The study, involving 49 participants who rolled over into the OLE for up to 60 weeks of treatment at 200 mg BID, demonstrated a favorable long-term safety profile and sustained disease control. Key metrics included an annualized FSCD-related event rate of 3%, with only one endoscopic balloon dilation reported and no surgeries. Radiological assessments indicated stabilization of fibrotic strictures, and 97% of evaluable patients were in clinical remission at Week 48. These results support the initiation of the global NOV-ERA Phase 2b study, which plans to enroll approximately 320 patients across three dose levels. AgomAb Therapeutics NV is a clinical-stage biopharmaceutical company developing therapies for fibro-inflammatory diseases.