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Agomab Announces Design of NOV-ERA Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease

Key Takeaway: Agomab Therapeutics has announced the design of its Phase 2b NOV-ERA study for ontunisertib, aimed at treating Fibrostenosing Crohn's Disease. The study has received regulatory alignment from the FDA on key design elements, including a novel primary endpoint. The company expects to begin dosing participants in the second half of 2026.
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POSITIVE FACTORS

  • Regulatory alignment with the FDA on study design.
  • Novel primary endpoint of endoscopic passability.
  • Study initiation is on track for 2026.

Full Press Release Details

— Regulatory alignment with U.S. Food and Drug Administration (FDA) on key elements of NOV-ERA Phase 2b study design, including novel primary endpoint of endoscopic passability — Study initiation on track, with first participants expected to be dosed in the second half of 2026
Antwerp, Belgium, June 23, 2026 – Agomab Therapeutics NV (Nasdaq: AGMB) (“Agomab” or the “Company”), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (or TGF-β RI) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD).

Frequently Asked Questions

What is the NOV-ERA Phase 2b study?

The NOV-ERA Phase 2b study is designed to evaluate ontunisertib for treating Fibrostenosing Crohn's Disease.

When will the study participants be dosed?

The first participants are expected to be dosed in the second half of 2026.

What is the primary endpoint of the study?

The primary endpoint of the study is endoscopic passability.

Who is conducting the NOV-ERA study?

The study is being conducted by Agomab Therapeutics NV.

Last updated: Jun 23, 2026