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Agomab Announces Positive Topline Phase 2a Data for Ontunisertib in Fibrostenosing Crohn’s Disease

Monday, November 17, 2025 BiopharmaWatch Research 1 min read
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Key Takeaway: Agomab Therapeutics has reported positive topline results from its Phase 2a clinical trial of ontunisertib, an oral small molecule inhibitor targeting ALK5, for treating Fibrostenosing Crohn's Disease. The trial involved 103 participants who completed 12 weeks of treatment, indicating potential efficacy in this challenging condition.

Market Sentiment Analysis

POSITIVE FACTORS

  • Positive topline data from Phase 2a trial
  • 103 participants completed 12 weeks of treatment
  • Ontunisertib shows promise for Fibrostenosing Crohn's Disease

Full Press Release Details

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).

Frequently Asked Questions

What is ontunisertib?

Ontunisertib is an investigational oral small molecule inhibitor targeting ALK5.

What condition is ontunisertib being tested for?

It is being tested for Fibrostenosing Crohn's Disease.

How many participants were in the Phase 2a trial?

The trial included 103 participants.

What were the results of the trial?

The trial reported positive topline data after 12 weeks of treatment.

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Last updated: Nov 17, 2025

Biotech snapshot

Lead asset
AGMB-129Phase 2
Fibrostenotic Crohn's Disease →