AgomAb Therapeutics starts ontunisertib Phase 2b trial
NOV-ERA uses 1:1:1:1 randomization and includes a six-week screening period followed by a two-week follow-up period.
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Rhea-AI Filing Summary
AgomAb Therapeutics NV (AGMB) announced that the first patient has been dosed in NOV-ERA, its global Phase 2b study of ontunisertib for symptomatic fibrostenosing Crohn’s disease (FSCD). The randomized, double-blind, placebo-controlled study is expected to enroll approximately 320 adult patients. Participants receive ontunisertib at 400 mg, 200 mg or 100 mg twice daily, or matching placebo, for a 52-week treatment period. The primary endpoint is the proportion achieving endoscopic passability of the ileal index stricture at Week 24.
Study initiation triggers a €7 million milestone payment to former Origo Biopharma shareholders under AgomAb’s 2021 acquisition of the company. That acquisition included up to €20 million in potential development and regulatory milestone payments; €10 million has become payable to date, including a €3 million milestone paid in 2025. Ontunisertib is investigational and not approved by any regulatory authority; its efficacy and safety have not been established.
Key Figures
Key Terms
Fibrostenosing Crohn’s Disease (FSCD) medical
endoscopic passability medical
ALK5 (or TGF-β RI) medical
Fast Track Designation regulatory
rapid first-pass metabolism technical
FAQ
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of October 2026
Commission File Number: 001-43098
AgomAb Therapeutics NV
Posthoflei 1/6
2600 Antwerpen
Belgium
Tel: +32 3 318 91 70
(Address, Including Zip Code, and Telephone Number,
Including Area Code, of Registrant’s Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
On October 13, 2026, the Company issued a press release titled, “Agomab Announces First Patient Dosed in Global NOV-ERA Phase 2b Study of Ontunisertib in Fibrostenosing Crohn's Disease.” A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information contained in this Form 6-K, including Exhibit 99.1, except for the quotes by Philippe Wiesel, MD, is hereby incorporated by reference into the Company’s Registration Statement on Form S-8 (File No. 333-294220).
Forward-Looking Statements
This Report of Foreign Private Issuer on Form 6-K may contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by the use of words such as “may,” “will,” “estimate,” “future,” “forward,” “anticipate,” or other similar words. Any statement describing the Company’s future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the potential of ontunisertib for the treatment of Fibrostenosing Crohn’s disease, the expected conduct and progress of the NOV-ERA Phase 2b study, our interactions with regulatory authorities and the Company’s future expectations, plans and prospects. Such statements are based on the Company’s current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, including the risk that preliminary or interim data may not reflect final results, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in the Company’s Annual Report, filed on Form 20-F with the SEC, and in subsequent filings with the SEC. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. Investors should not place undue reliance on these forward-looking statements, which apply only as of the date of this Report of Foreign Private Issuer on Form 6-K.
EXHIBIT LIST
| Exhibit | Description | |
| 99.1 | Press Release of AgomAb Therapeutics NV dated October 13, 2026 | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| AgomAb Therapeutics NV | ||
| Date: October 13, 2026 | By: | /s/ Tim Knotnerus |
| Tim Knotnerus | ||
| Chief Executive Officer | ||
Exhibit 99.1
Agomab Announces First Patient Dosed in Global NOV-ERA Phase 2b Study of Ontunisertib in Fibrostenosing Crohn's Disease
-- 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