Agomab Therapeutics is taking its lead candidate, ontunisertib, to a Phase IIb trial following its mid-stage success in fibrostenosing Crohn’s disease (FSCD).
During the Phase IIa STENOVA study (NCT05843578), the oral activin receptor-like kinase 5 (ALK5) inhibitor was proven to be safe and tolerable over a 12-week treatment period in Crohn’s patients with symptomatic narrowing of the ileum.
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This was evidenced by both the incidence and severity of adverse events (AEs) observed in the treatment and placebo arms, which remained similar throughout the study. The drug also triggered no treatment-emergent cardiac toxicity or inflammation.
Ontunisertib, which was developed to specifically target the gastrointestinal (GI) tract, was also found to trigger minimal systemic exposure to the drug. Meanwhile, pharmacokinetic (PK) tests indicated patients experienced a high local exposure to the drug within the targeted region.
The targeted therapy also exhibited positive trends towards a range of efficacy endpoints, including the simple endoscopic score of Crohn’s disease (SES-CD). SES-CD measures symptom severity in patients through an assessment of intestinal ulcer prevalence and surface area.
More specifically to FSCD, ontunisertib demonstrated a trend towards improvements in magnetic resonance enterography (MRE) results, which are used to measure the severity of ileal narrowing.
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By GlobalDataAccording to Florian Rieder, vice-chair of the Cleveland Clinic’s department of gastroenterology, the results of the STENOVA study highlight “ontunisertib’s potential as a novel treatment option” for FSCD – an indication with no approved anti-fibrotic medications.
Agomab’s next steps for ontunisertib
Following the positive results of the STENOVA study, Agomab plans to liaise with regulators on proceedings for a Phase IIb trial. The Belgian biotech will also present more detailed data at a future scientific conference.
The drug previously received fast-track designation from the US Food and Drug Administration (FDA), becoming the first in FSCD to achieve this milestone. If it gets the green light, it could become the first anti-fibrotic drug to gain approval in this indication.
The current standard of care (SoC) for FSCD revolves around the use of anti-tumour necrosis factor (TNF) drugs such as Remicade (infliximab) and AbbVie’s Humira (adalimumab). However, these drugs only target Crohn’s disease-driven inflammation, and not the intestinal fibrosis underpinning FSCD’s pathology.
Traditionally, it has been challenging to develop anti-fibrotic medications due to the strong heterogeneity observed across patient populations and a lack of understanding on the mechanisms underpinning fibrosis.
This is evidenced by the termination of the Phase II trial of Boehringer Ingelheim’s Spevigo (spesolimab) in FSCD, as the drug exhibited limited efficacy in the disease. The drug was subsequently sold to Leo Pharma in July 2025 following its FDA approval in generalised pustular psoriasis (GPP).
However, other companies in the space have not been deterred by this setback. This includes Medibiofarm, which completed its Phase IIa trial on PPAR-γ receptor, MBF-118, in September 2025.
