Agomab Announces Positive Topline Phase 2a Data for Ontunisertib in Fibrostenosing Crohn’s Disease
— STENOVA trial achieves primary endpoint in 103 study participants after 12 weeks of treatment —
— Pharmacokinetic results confirm gut-restricted profile of ontunisertib in FSCD patients —
— Positive efficacy signals observed for several exploratory clinical endpoints —
— Ongoing open-label extension study supports longer-term safety and tolerability profile observed to date —
Antwerp, Belgium, November 17, 2025 – Agomab Therapeutics NV (‘Agomab’) today announced positive data from 103 participants completing 12 weeks of treatment in the STENOVA1 Phase 2a 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 company also provided a safety update on the ongoing open-label extension (OLE) study with ontunisertib.
STENOVA, a first-in-indication study, is a two-part Phase 2a trial in Crohn’s patients with symptomatic ileal strictures. Part A is a randomized, double-blind, placebo-controlled study in a total of 103 participants. Participants have been randomized to receive either 100mg QD or 200mg BID of ontunisertib or placebo for 12 weeks on top of standard of care, including anti-inflammatory biologics. The study has investigational sites in the USA, Canada and six European countries. 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). Eligible study participants who have completed the double-blind 12-week treatment period can participate in the OLE part of the STENOVA study (Part B) and receive ontunisertib 200mg BID for up to an additional 48 weeks.
“As a first-in-indication, first-in-class trial, STENOVA is a landmark study that demonstrates the feasibility of recruiting and conducting a clinical investigation in patients with Fibrostenosing Crohn’s Disease. The STENOVA data represent a major contribution to the development of registrational endpoints in the field,” commented Florian Rieder, MD, Vice-Chair Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, OH. “The results announced today underscore ontunisertib’s potential as a novel treatment option for patients suffering from this debilitating disease.”
Part A of the STENOVA study achieved its primary endpoint, with the observed safety profile supporting further clinical development. The severity and incidence of adverse events were similar among treatment arms, including placebo. There were no signs of treatment related cardiac toxicity, no pro-inflammatory effects, and no signals in safety labs, vital signs, and physical exams. With regard to the secondary endpoints, the PK profile indicated high local exposure to ontunisertib in the GI tract, with minimal systemic exposure. These results are consistent with prior data in healthy participants and confirm the gut-restricted profile of ontunisertib in FSCD patients. The analysis of the target engagement data is ongoing.
Positive trends were observed across several exploratory clinical endpoints, including the SES-CD score and MRE parameters, supporting the potential dual anti-inflammatory and anti-fibrotic mode of action of ontunisertib. SES-CD is a clinically meaningful disease activity score in Crohn’s Disease studies, and MRE is widely used to assess strictures in FSCD patients.
Furthermore, in the ongoing open-label extension study, ontunisertib continues to show a generally favorable safety and tolerability profile, with study participants receiving ontunisertib 200mg BID for up to 36 weeks in total to date.
The company plans to discuss the STENOVA results with regulatory authorities and prepare for a Phase 2b study. Agomab also intends to present detailed STENOVA results at a future scientific conference.
“We are very pleased with the STENOVA results announced today. The trial recruited faster and enrolled more patients than originally anticipated, underscoring the strong investigator support and patient interest. The data demonstrate that ontunisertib has the potential to safely target the key fibrotic TGFβ/ALK5 pathway in a gut-restricted fashion. Observing efficacy signals on multiple clinical exploratory endpoints is very encouraging, especially in patients with longstanding Crohn’s disease already receiving advanced therapies,” said Philippe Wiesel, Chief Medical Officer at Agomab. “We want to extend our gratitude to the STENOVA investigators, site personnel, and especially the study participants.”
Ontunisertib is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.
About ontunisertib
Ontunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of ALK5 (or TGF-b RI) currently in clinical development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-b is a major driver of fibrosis. Ontunisertib is specifically designed to inhibit ALK5/TGF-b in the GI-tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an improved safety profile over systemically available inhibitors in this class. Ontunisertib has received U.S. FDA Fast Track Designation.
About Fibrostenosing Crohn’s Disease
Crohn’s disease is a chronic progressive disease of the gastrointestinal tract. It is estimated that approximately 46% of patients with Crohn’s disease have fibrosis of the gastrointestinal tract, resulting in stricture formation and intestinal obstructions, most frequently in the terminal ileum. These strictures can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD.
About Agomab
Agomab is focused on achieving disease modification by modulating fibrosis and inflammation in chronic indications such as Fibrostenosing Crohn’s Disease and Idiopathic Pulmonary Fibrosis. We do this by targeting biologically validated pathways, including Transforming Growth Factor β, and by applying specialized capabilities in organ-restricted small molecules. With a unique clinical pipeline across several fibrotic disorders, end-to-end research and development capabilities, a proven track-record and a strong investor base, Agomab is building a transformational company with the aim to have a real impact on patients’ lives.
Contacts
Investors
Sofie Van Gijsel
VP of Investor Relations
E-Mail: sofie.vangijsel@agomab.com
Phone: +1 781 296 1143
Media
Eva Mulder or Gretchen Schweitzer
Trophic Communications
E-Mail: agomab@trophic.eu
Phone: +31 6 52 33 15 79 or +49 172 861 8540
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