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

The study's initiation triggers a €7 million payment obligation under the terms of Agomab's acquisition of Origo Biopharma.

Rhea-AI Summary

Agomab (AGMB) has dosed the first patient in NOV-ERA, its global Phase 2b study of ontunisertib for symptomatic fibrostenosing Crohn's disease.

The randomized, double-blind, placebo-controlled study is expected to enroll approximately 320 adults. Participants will receive 400 mg, 200 mg or 100 mg twice daily, or matching placebo, for 52 weeks. The primary endpoint is endoscopic passability—whether an endoscope can pass through the affected bowel—at Week 24. Agomab said positive Phase 2a STENOVA results support continued development, while long-term safety and tolerability findings from its open-label extension support the 400 mg twice-daily arm.

Study initiation triggers a €7 million milestone payment to former Origo Biopharma shareholders under Agomab's 2021 acquisition. That agreement included up to €20 million in potential development and regulatory milestones; €10 million has become payable to date.

4 points · 0 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointFirst patient dosed advances ontunisertib into the global NOV-ERA Phase 2b study for symptomatic fibrostenosing Crohn's disease.
• Minor point. Forward-looking: it has not happened yet and may not happen.NOV-ERA is expected to enroll approximately 320 adults, evaluating three twice-daily doses against placebo over 52 weeks.
• Minor point. Forward-looking: it has not happened yet and may not happen.Week 24 endoscopic passability is the primary endpoint for the study assessing safety and efficacy.
• Minor pointPhase 2a STENOVA findings support continued development and the 400 mg twice-daily arm, Agomab said.

Negative

• Moderate point€7 million milestone payment is triggered for former Origo shareholders; €10 million has become payable under up to €20 million in potential milestones.

Key Figures

Planned enrollment: Approximately 320 patients Dose levels: 400 mg BID, 200 mg BID, and 100 mg BID Treatment duration: 52 weeks +4 more

Planned enrollment

Approximately 320 patients

Global NOV-ERA Phase 2b study

Dose levels

400 mg BID, 200 mg BID, and 100 mg BID

Ontunisertib treatment arms

Treatment duration

52 weeks

NOV-ERA study

Primary endpoint timing

Week 24

Endoscopic passability

Triggered milestone payment

€7 million

Payable to former Origo Biopharma shareholders upon study initiation

Potential development and regulatory milestones

Up to €20 million

Terms of Agomab's 2021 acquisition of Origo Biopharma

Milestones payable to date

€10 million

Includes a €3 million milestone paid in 2025

Historical Context

1 past event · Latest: Oct 01

1 event

1. Oct 01

   Phase 2a data

   24h Move

   -22.3%

   STENOVA extension reported favorable safety/tolerability and 97% remission; current release cites it as development support.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

placebo-controlled, open-label extension, primary endpoint, bid

4 terms

placebo-controlled medical

"randomized, double-blind, placebo-controlled, multicenter Phase 2b study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

open-label extension medical

"open-label extension (OLE) part of the STENOVA Phase 2a study"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

primary endpoint medical

"with endoscopic passability at Week 24 as primary endpoint"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

bid medical

"400 mg BID, 200 mg BID, and 100 mg BID"

A bid is the price a buyer is willing to pay for a share or other security at a given moment. It signals demand and helps set the market price — the gap between buyers’ bids and sellers’ asking prices shows how easy or costly it is to trade, much like a shopper offering a price at a flea market and comparing it to the seller’s sticker. Investors watch bids to gauge interest, execution likelihood, and short-term price direction.

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-- NOV-ERA is designed to assess the efficacy and safety of ontunisertib in approximately 320 patients with symptomatic Fibrostenosing Crohn's disease (FSCD) --

-- Global, randomized, placebo-controlled, dose-ranging study to evaluate three dose levels of ontunisertib, with endoscopic passability at Week 24 as primary endpoint --

-- Study initiation represents an important milestone in the development of ontunisertib as a potential first targeted anti-fibrotic treatment for FSCD --

Antwerp, Belgium, October 13, 2026 – Agomab Therapeutics NV (‘Agomab’), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that the first patient has been dosed in NOV-ERA, the Company's global Phase 2b study evaluating ontunisertib in patients with symptomatic FSCD.

NOV-ERA is a randomized, double-blind, placebo-controlled, multicenter Phase 2b study designed to assess the safety and efficacy of ontunisertib. The study is expected to enroll approximately 320 adult patients globally. Participants will be randomized to receive either ontunisertib at one of three dose levels (400 mg BID, 200 mg BID, and 100 mg BID), or a matching placebo for a treatment duration of 52 weeks.

The initiation of NOV-ERA follows the positive Phase 2a STENOVA results that support continued clinical development of ontunisertib in FSCD. The recently announced positive long-term safety and tolerability findings of the open-label extension (OLE) part of the STENOVA Phase 2a study provide strong support for the inclusion of a 400 mg BID treatment arm in the NOV-ERA study.

Philippe Wiesel, Chief Medical Officer of Agomab, commented: “Dosing the first patient in NOV-ERA marks the beginning of an exciting next chapter for our Company and for the late-stage development of ontunisertib. FSCD is associated with progressive bowel damage and a substantial burden for patients; yet there are currently no approved therapies that specifically address the fibrotic component of the disease. NOV-ERA is designed to evaluate the efficacy and safety of ontunisertib and to provide important data across multiple imaging modalities, clinical endpoints, and patient-reported outcomes. We are grateful to the patients, investigators and clinical sites participating in this global study.”

The initiation of the NOV-ERA study triggers a €7 million milestone payment to the former shareholders of Origo Biopharma under the terms of Agomab's 2021 acquisition of the company. The acquisition included up to €20 million in potential development and regulatory milestone payments. To date, €10 million has become payable, including a €3 million milestone paid in 2025, reflecting continued progress in the development of the program.

Ontunisertib is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established. 

About NOV-ERA
The NOV-ERA study is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in patients diagnosed with symptomatic ileal strictures. The trial is expected to enroll approximately 320 adult patients globally. To be eligible for the trial, participants must have at least one naive or anastomotic endoscopically non-passable ileal stricture, confirmed by central reading. Upon study initiation, participants will be randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of three dose levels (400 mg, 200 mg, and 100 mg), or a matching placebo, administered twice daily (BID). The trial will consist of a 6-week screening period, a 52-week treatment period, and a 2-week follow-up period. The primary endpoint is the proportion of patients achieving endoscopic passability of the ileal index stricture at Week 24.

Key secondary efficacy endpoints include: 

• Proportion of participants achieving endoscopic passability of the ileal index stricture at Week 52.
• Time to an FSCD-related event (including bowel surgery and endoscopic balloon dilation).
• Change from baseline in Magnetic Resonance Enterography (MRE) imaging features of the index stricture at Week 24 and Week 52.
• Change from baseline in total SES-CD at Week 24 and Week 52.
• Proportion of participants with an endoscopic response and remission at Week 24 and Week 52 compared to baseline.
• Change from baseline in Patient-Reported Outcome questionnaire for stricturing Crohn’s disease (S-PRO 2.0) severity score, Crohn’s disease activity index (CDAI) and quality of life instruments at Week 24 and Week 52.

The endpoints assessed in the NOV-ERA study are designed to inform the selection of potential registrational endpoints for ontunisertib in FSCD.

About Ontunisertib
Ontunisertib (AGMB-129) is an oral small molecule GI-restricted inhibitor of ALK5 (or TGF-β RI) currently in clinical development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-β is a major driver of fibrosis. Ontunisertib is specifically designed to inhibit ALK5/TGF-β in the GI-tract. Rapid first-pass metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an improved safety profile over systemically available inhibitors in this class. Ontunisertib has received U.S. FDA Fast Track Designation.

About Agomab
Agomab is a clinical-stage biopharmaceutical company focused on developing novel disease-modifying therapies for fibro-inflammatory diseases with high unmet medical need. Agomab’s product candidates are designed to target established, potent pathways and utilize organ-restricted approaches, with the aim of increasing efficacy while minimizing safety liabilities. Fostering a culture of excellence, Agomab’s mission is to pioneer therapeutics that aim to resolve fibro-inflammation and restore organ function to enable people with these disorders to live fuller and healthier lives.

Cautionary Note regarding Forward-Looking Statements
This press release includes certain disclosures that contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are often identified by terms such as "continue," "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. “Forward-looking statements” include, without limitation, statements regarding the potential of ontunisertib for Fibrostenosing Crohn’s disease, the expected conduct and progress of the NOV-ERA Phase 2b study, and our interactions with regulatory authorities. Forward-looking statements are based on Agomab’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the results of our clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements for product candidates; the impact of governmental laws and regulations on our business; and disruptions caused by our reliance on third party suppliers and service providers. These and other risks and uncertainties are described more fully in our filings and reports with the SEC, including in our most recent annual report on Form 20‐F filed with the SEC and our subsequent filings and reports filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Agomab undertakes no duty to update such information except as required under applicable law. Readers should not rely upon the information in this announcement as current or accurate after its publication date.

Contacts
Investors
Sofie Van Gijsel
VP of Investor Relations
E-Mail: sofie.vangijsel@agomab.com
Phone: +1 781 296 1143
        
Media
Gretchen Schweitzer
Trophic Communications
E-Mail: agomab@trophic.eu 
Phone: +49 172 861 8540

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Agomab's NOV-ERA trial testing?

NOV-ERA evaluates ontunisertib's safety and efficacy in symptomatic fibrostenosing Crohn's disease, with endoscopic passability at Week 24 as its primary endpoint. Approximately 320 adults are expected to receive 400 mg, 200 mg or 100 mg twice daily, or matching placebo, for 52 weeks.

What milestone payment does Agomab's NOV-ERA initiation trigger?

Initiation triggers a €7 million payment to former Origo Biopharma shareholders under Agomab's 2021 acquisition terms. The acquisition included up to €20 million in potential development and regulatory milestone payments. To date, €10 million has become payable, including a €3 million milestone paid in 2025.