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Agomab Announces Positive Topline Phase 2a Data for Ontunisertib in Fibrostenosing Crohn’s Disease
Antwerp, Belgium, November 17, 2025 Agomab Therapeutics NV (‘Agomab’) today announced positive data from 103 participants completing 12 weeks of treatment in the STENOVA Phase 2a clinical trial for ontunisertib (AGMB-129), an investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (TGFβ RI or ALK5) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). The company also provided a safety update on the ongoing open-label extension (OLE) study with ontunisertib.
Late-Breaking Interim STENOVA Data Presented at Digestive Disease Week® 2025 Demonstrate Potential of AGMB-129 in Fibrostenosing Crohn’s Disease
Antwerp, Belgium, May 6, 2025
Agomab Therapeutics NV (“Agomab”) today announced latebreaking interim data from the ongoing STENOVA1 Phase 2a clinical trial for AGMB-129, an oral gastrointestinal (GI)-restricted small molecule inhibitor of ALK5 (TGFβ RI or ALK5) developed for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). The interim results were presented by Florian Rieder, MD, at Digestive Disease Week® (DDW) 2025, taking place in San Diego on May 3-6, 2025.
Late-Breaking Interim STENOVA Data for AGMB-129 in Fibrostenosing Crohn’s to be Presented at Digestive Disease Week® 2025
Antwerp, Belgium, April 10, 2025
Agomab Therapeutics NV (‘Agomab’) today announced that interim data from the ongoing STENOVA1 Phase 2a clinical trial for AGMB-129, an oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (TGFβ-RI or ALK5) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD), will be presented as a late-breaking presentation at Digestive Disease Week® (DDW) 2025, taking place in San Diego on May 3-6, 2025. STENOVA is a randomized, double-blind, placebo-controlled study in a total of 90 patients with symptomatic FSCD. Patients are randomized to receive one of two doses of AGMB-129 or placebo for 12 weeks on top of standard of care, including anti-inflammatory biologics. The multi-center study is global with investigational sites in the USA, Canada and Europe. The primary endpoints are the safety and tolerability of AGMB-129 in FSCD patients. Secondary endpoints include pharmacokinetics and target engagement as measured through transcriptomics in mucosal biopsies collected at the site of the ileal strictures.
“WE ARE DETERMINED TO IMPROVE THE LIVES OF PATIENTS WITH FIBROTIC DISEASES. WE ARE BUILDING A LEADING COMPANY THAT COMBINES TRANSFORMATIVE SCIENCE WITH THE COMMITMENT AND PASSION OF OUR EXPERIENCED TEAM, PARTNERS, AND INVESTORS.”
Tim Knotnerus, Chief Executive Officer
