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AGOMAB Agomab Reports Positive Topline Data from STENOVA Open - Label Extension Study of Ontunisertib in Fibrostenosing Crohn's Disease October 1 , 2026 -- - -- Favorable safety and tolerability profile maintained through up to 60 weeks of treatment with ontunisertib in Fibrostenosing Crohn's disease ( FSCD ) patients -- Low annualized FSCD - related event rate of 3 % , with one endoscopic balloon dilation ( EBD ) and no surgeries reported over the full treatment period -- -- -- Radiological assessment shows trend for fibrotic stricture stabilization over treatment course -- Sustained disease control observed across symptoms and disease activity scores in Open - Label Extension Study ( OLE ) -- -- Results support initiation of global NOV - ERA Phase 2b study in FSCD in the coming months -- Company to host webcast today at 8:30 a.m. Eastern Time -- Antwerp , Belgium , October 1 , 2026 - Agomab Therapeutics NV ( ' Agomab ' ) a clinical - stage biopharmaceutical company focused on fibro - inflammation , today announced positive results of the 48 - week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with FSCD , a severe manifestation of Crohn's disease characterized by progressive bowel fibrosis and intestinal strictures . The OLE study ( Part B ) evaluated long - term treatment with ontunisertib 200 mg BID on top of standard of care . Of the participants eligible to roll over into the OLE study from the 12 - week placebo - controlled Part A of STENOVA , 94 % elected to enter the study ( n = 49 ) . The results demonstrated a generally favorable long - term safety and tolerability profile of ontunisertib 200 mg BID for up to 60 weeks of treatment , as well as maintenance of the gut - restricted pharmacokinetic ( PK ) profile observed in Part A of the trial . Sustained disease control , with low symptoms and disease activity scores and radiological stricture stabilization , was also observed . Importantly , a low FSCD - related annualized event rate of 3 % was reported in patients treated with ontunisertib 200 mg BID up to 60 weeks . " Fibrostenosing Crohn's disease remains one of the most significant unmet needs in fibro - inflammatory bowel disease , with no approved therapies targeting the fibrotic component of the disease , " commented Florian Rieder , MD , 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 . 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 . 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 , added : “ We are very pleased with the OLE results announced today . 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 . 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 . 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 . " Topline STENOVA OLE results Safety and tolerability profile Ontunisertib 200 mg BID demonstrated a generally favorable safety and tolerability profile through up to 60 weeks of treatment . Five serious adverse events were reported in four patients in Part B of the STENOVA study ( 48 - week OLE ) ; all of which were considered unrelated or unlikely related to study treatment . There were no signals of cardiac injury , pro - inflammatory effects , vasculitis , liver toxicity or thrombotic events during the extended treatment period . Pharmacokinetic ( PK ) profile