Agomab to present STENOVA OLE data at UEG Week 2026

Agomab Therapeutics has announced that open-label extension data from the STENOVA Phase 2a study of ontunisertib will be presented in an oral session at United European Gastroenterology Week 2026, taking place 17–20 October in Barcelona. The Antwerp-based company also confirmed it will host a sponsored scientific symposium on the role of fibro-inflammation in inflammatory bowel disease at the same event.

The OLE data, covering Part B of the STENOVA study, assessed long-term treatment with ontunisertib 200 mg twice daily for up to 60 weeks in patients with symptomatic fibrostenosing Crohn's disease (FSCD). Of 52 eligible patients who completed the 12-week double-blind treatment phase, 49 (94%) rolled over into the extension, and 37 completed the full 48-week OLE period. The extension evaluated long-term safety, pharmacokinetics and disease-event rates, and will be presented by Florian Rieder, Vice-Chair of Gastroenterology at Cleveland Clinic, on 20 October.

Rieder said the findings "highlight the potential of ontunisertib to provide a meaningful clinical benefit for people living with FSCD," and expressed confidence that a deeper understanding of the crosstalk between inflammation and fibrosis could advance therapeutic options for patients facing progressive bowel damage.

Path to Phase 2b

Agomab's chief medical officer Philippe Wiesel said the OLE results reinforce the company's confidence as it advances the global Phase 2b NOV-ERA study "in the coming months." NOV-ERA is a randomised, double-blind, placebo-controlled, dose-ranging, multicentre trial designed to enrol up to 320 adult patients globally. Participants will be randomised 1:1:1:1 across three dose levels (100 mg, 200 mg, and 400 mg twice daily) and placebo, over a 52-week treatment period. The primary endpoint is the proportion of patients achieving endoscopic passability of the ileal index stricture at week 24, a clinically meaningful, objective measure of structural disease.

Ontunisertib is an oral, small-molecule, GI-restricted inhibitor of ALK5, the type I TGF-beta receptor. TGF-beta signalling is a well-characterised driver of fibrosis, and the drug is engineered to undergo rapid first-pass hepatic metabolism, limiting systemic exposure and potentially improving the safety profile relative to non-restricted ALK5 inhibitors. The candidate holds FDA Fast Track Designation.

Market context

FSCD represents a subset of Crohn's disease characterised by stricturing complications that frequently require surgery or endoscopic dilation, and there is currently no approved pharmacological therapy targeting the fibrotic component. The broader IBD treatment landscape is dominated by anti-inflammatory biologics, including TNF inhibitors and integrin-targeted agents, but these address inflammation rather than established fibrosis, leaving a structural gap in treatment that multiple research groups are seeking to fill.

Agomab is among a small number of companies developing anti-fibrotic strategies specifically for the gastrointestinal tract. The organ-restricted approach mirrors design logic seen in other GI-targeted programmes, where limiting systemic drug exposure is used to manage class-effect safety concerns. The readout from NOV-ERA, when it comes, will be among the first Phase 2b datasets to test whether pharmacological reversal or stabilisation of ileal strictures is achievable at scale, making it a closely watched signal for the field.

Ontunisertib remains investigational and has not been approved by any regulatory authority.