Agomab Doses First Patient in NOV-ERA Phase 2b FSCD Study

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IPO:
Feb 06, 2026
Industry:
BIOLOGICAL PRODUCTS, (NO DISGNOSTIC SUBSTANCES)

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Agomab Announces First Patient Dosed in Global NOV-ERA Phase 2b Study of Ontunisertib in Fibrostenosing Crohn's Disease

Antwerp, Belgium, October 13, 2026 - Agomab Therapeutics NV announced that the first patient has been dosed in NOV-ERA, its global Phase 2b study evaluating ontunisertib in patients with symptomatic fibrostenosing Crohn's disease (FSCD).

NOV-ERA is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the safety and efficacy of ontunisertib in approximately 320 adult patients globally. Participants are assigned to receive one of three dose levels of ontunisertib or a matching placebo for a treatment duration of 52 weeks.

Study Highlights

  • Evaluation of three dose levels: 400 mg BID, 200 mg BID, and 100 mg BID.
  • Primary endpoint is endoscopic passability of the ileal index stricture at Week 24.
  • Study initiation triggers a EUR 7 million milestone payment under Agomab's previous acquisition terms.

About Agomab Therapeutics NV

We are a clinical-stage biopharmaceutical company focused on developing novel disease-modifying therapies for immunology and inflammatory diseases, with an initial focus on chronic fibrotic indications with high unmet medical need. Our product candidates are designed to target established pathways and utilize validated modalities with the aim of increasing efficacy while avoiding systemic toxicities in order to overcome the limitations of prior therapeutic approaches. Our initial focus for the treatment of fibrosis is through inhibition of one of the key signaling pathways involved in fibrosis, the transforming growth factor β, or TGFβ, pathway. Our mission is to develop disease-modifying therapeutics that aim to resolve fibrosis and restore organ function to enable patients with these disorders to live fuller and healthier lives.

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