Agomab Reports Positive Topline Data from STENOVA Open-Label Extension Study of Ontunisertib in Fibrostenosing Crohn's Disease

Florian Rieder, Vice-Chair, Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic

“Beyond the favorable safety and tolerability profile, what stands out in the OLE results is the sustained disease control as well as the low rate of interventions, with only one EBD and no surgeries reported.”

Florian Rieder, Vice-Chair, Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic

“Importantly, patients appeared to continue to do well on long-term treatment with ontunisertib, maintaining low symptom levels and favorable outcomes on quality-of-life assessments.”

Florian Rieder, Vice-Chair, Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic

“In a patient population often facing progressive bowel damage and recurrent procedures, these combined findings point to the potential of ontunisertib to provide a meaningful clinical benefit.”

Philippe Wiesel, Chief Medical Officer of Agomab

“We are very pleased with the OLE results announced today.”

Philippe Wiesel, Chief Medical Officer of Agomab

“The favorable long-term safety profile, maintenance of gut-restricted exposure and signals of sustained disease control observed over up to 60 weeks of treatment provide strong support for the initiation of our global NOV-ERA Phase 2b study later this year.”

Philippe Wiesel, Chief Medical Officer of Agomab

“Importantly, these data further support our belief that targeting fibro-inflammation through a differentiated anti-fibrotic mechanism may address a key driver of disease progression that remains largely untreated today.”

Philippe Wiesel, Chief Medical Officer of Agomab

“We look forward to evaluating ontunisertib across multiple dose levels in NOV-ERA as we continue to advance what we believe is a potentially novel therapeutic approach for people living with fibro-inflammatory conditions.”