Data Readout

Agomab's ontunisertib extension data due H2 2026 will test durability in Crohn's

The open-label extension of the STENOVA trial will show whether ontunisertib's Part A benefit in fibrostenosing Crohn's holds through 48 weeks, with no approved disease-modifying comparator to beat.

By AppliedXLJuly 13, 2026Trial NCT05843578

Executive Summary

Agomab is heading toward a second-half-2026 readout from the long-term extension of its Crohn's disease trial, a data point meant to confirm durability rather than establish efficacy for the first time.
The result will shape how the company designs its larger Phase 2b study, already slated to start in the same window, making this readout a bridge rather than a terminal catalyst.
No approved disease-modifying treatment exists for this fibrostenosing form of Crohn's, and ontunisertib stands as the only late-preclinical-to-clinical ALK5 program tested specifically in this population, so the comparison is against natural history and its own earlier result, not a rival drug.
The double-blind portion of the same trial already reported a positive topline result, presented at a major GI congress, which raises the bar for the extension to sustain that signal rather than merely replicate a first look.

The catalyst

Agomab expects topline data in the second half of 2026 from Part B, the open-label extension, of its STENOVA study of ontunisertib (AGMB-129) in fibrostenosing Crohn's disease (FSCD), the company said. The trial is registered as NCT05843578, a Phase 2 study that finished enrolling 103 patients and is listed as Active, not recruiting, with a primary completion date of September 1, 2026. The extension dosing protocol calls for 200 mg twice daily of ontunisertib for up to 60 weeks, and a Data Safety and Monitoring Board reviewing the study as of February 2026 had not raised a safety issue and recommended it continue as designed. Agomab+1

Probability of Success

Endpoint Met24%

Completes67%

Clinical Significance12%

Regulatory45%

What already happened

The 12-week, placebo-controlled, double-blind portion of the same trial, Part A, already reported positive topline results, presented as a late-breaker at the European Crohn's and Colitis Organisation congress in Stockholm in February 2026 and highlighted by Nature Reviews Gastroenterology & Hepatology. The company frames the coming extension data as adding "important insights into extended treatment with ontunisertib in FSCD patients," a description that points to durability and tolerability over a longer horizon rather than a first efficacy signal. The registered primary endpoints for the trial are entirely safety-focused: the number of participants with abnormal lab values, ECG findings, vital signs, echocardiograms, adverse events, and physical exam findings across both Part A and Part B. Agomab+1

Operational history

The trial's primary completion date moved three times since its 2023 start, from December 2024 to December 2025, then to December 2026, before pulling in to September 2026 in May 2025, the same update that also lifted the enrollment target from 90 to 103 patients. That final target increase was 14% and the trial finished at that number, a routine adjustment against the trial's own scale rather than a shortfall; the earlier increase from 36 to 90 patients came while the study was still recruiting, before it closed enrollment in 2025. NCT05843578

The competitive field

No industry trial beyond ontunisertib is registered for the ALK5 target in fibrostenosing Crohn's disease specifically, and only a single other early-stage asset, Palisade Bio's PALI-2108, is active in the broader FSCD indication space, working through a different mechanism (PDE4). Across all indications, the wider ALK5 target field carries just one other active clinical program, a Phase 2/3 amyotrophic lateral sclerosis study of galunisertib testing pharmacodynamic biomarkers rather than a Crohn's endpoint. The nearest comparators in fibrostenosing Crohn's and adjacent inflammatory bowel disease are biologics and JAK inhibitors, such as tulisokibart, guselkumab, upadacitinib, and vedolizumab, all working through different mechanisms and none targeting the stricturing biology ontunisertib is designed to address.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.