Agomab Unveils Phase 2b Study Design for Ontunisertib in Fibrostenosing Crohn’s Disease

Agomab Therapeutics has announced the design of its upcoming Phase 2b NOV-ERA clinical trial for ontunisertib, an investigational oral therapy being developed for Fibrostenosing Crohn’s Disease (FSCD).

The company says the study marks an important step in advancing a potential treatment option for a condition that currently has no approved drug therapies. Agomab plans to begin dosing the first participants in the second half of 2026, pending final regulatory and ethics approvals.

The company has already aligned with the U.S. Food and Drug Administration (FDA) on the study design and primary endpoint, while approvals have also been secured in Canada. Clinical trial applications have been submitted across multiple regions, including Europe and Asia-Pacific markets.

A Major Unmet Need in Crohn’s Disease

Fibrostenosing Crohn’s Disease is a serious complication of Crohn’s disease that affects nearly half of all patients.

According to Agomab, around 46% of Crohn’s disease patients develop fibrotic strictures in the gastrointestinal tract. These narrowings can block the intestine and cause symptoms that affect daily life, including difficulty eating, dietary restrictions, malnutrition, and the need for surgery.

Despite the large patient population and significant disease burden, there are currently no approved pharmacological treatments specifically designed to treat FSCD.

NOV-ERA Study Designed to Evaluate Efficacy and Safety

The NOV-ERA trial is a randomized, double-blind, placebo-controlled, multicenter Phase 2b study that will evaluate both the efficacy and safety of ontunisertib in adults with symptomatic Fibrostenosing Crohn’s Disease.

The study is expected to enroll up to 320 patients worldwide.

To qualify for enrollment, patients must have at least one endoscopically non-passable ileal stricture that has been confirmed using the Simple Endoscopic Score for Crohn’s Disease (SES-CD).

Participants will be randomly assigned to one of four treatment groups.

Three groups will receive ontunisertib at different dose levels of 400 mg, 200 mg, or 100 mg, while the fourth group will receive a matching placebo.

The treatment will be administered twice daily.

The trial includes a six-week screening period, a 52-week treatment period, and a two-week follow-up phase.

Primary Endpoint Focuses on Intestinal Stricture Improvement

The main goal of the NOV-ERA study is to determine whether ontunisertib can improve intestinal strictures in patients with Fibrostenosing Crohn’s Disease.

The primary endpoint will measure the proportion of patients who achieve endoscopic passability of the ileal index stricture at Week 24.

In simple terms, researchers will assess whether previously blocked or narrowed sections of the intestine become passable following treatment.

This endpoint was selected following discussions and alignment with the FDA.

Secondary Endpoints Will Measure Broader Clinical Benefits

In addition to the primary endpoint, the study will evaluate several other measures designed to provide a broader picture of treatment impact.

Researchers will assess endoscopic passability again at Week 52 to evaluate longer-term benefits.

The trial will also examine changes in intestinal structure using Magnetic Resonance Enterography (MRE) imaging at both Week 24 and Week 52.

Additional evaluations will include changes in total SES-CD scores, rates of endoscopic response and remission, patient-reported symptom improvements using the S-PRO 2.0 questionnaire, and the time taken before patients experience FSCD-related events such as surgery or endoscopic balloon dilation.

According to Agomab, these endpoints are expected to help guide future registrational studies and support long-term development plans for ontunisertib.

Company Highlights Importance of the Study

Philippe Wiesel, Chief Medical Officer of Agomab, described the NOV-ERA trial as a significant step for patients living with Fibrostenosing Crohn’s Disease.

He noted that the study represents the first Phase 2b trial specifically focused on this condition and is designed to help identify appropriate dosing and future pivotal study endpoints.

Wiesel said the submission of the protocol to major regulatory agencies marks an important milestone in the development program and that the company is now focused on final operational preparations before patient recruitment begins.

How Ontunisertib Works

Ontunisertib, also known as AGMB-129, is an investigational oral small-molecule therapy designed to target fibrosis in the gastrointestinal tract.

The drug works by inhibiting ALK5, also known as Transforming Growth Factor Beta Receptor I (TGF-β RI).

TGF-β is considered one of the key biological drivers of fibrosis, the process responsible for tissue scarring and stricture formation in Fibrostenosing Crohn’s Disease.

What makes ontunisertib different is its gastrointestinal-restricted design.

The drug is intended to act primarily within the digestive tract while undergoing rapid metabolism in the liver, limiting systemic exposure throughout the body. This approach may help reduce safety concerns that have historically been associated with systemically available inhibitors targeting the same pathway.

The FDA has already granted Fast Track Designation to ontunisertib, recognizing its potential to address a serious condition with significant unmet medical need.

Global Development Efforts Continue

Agomab continues to advance ontunisertib as part of its broader strategy to develop therapies for fibro-inflammatory diseases.

The company focuses on creating treatments that target key disease pathways while limiting unwanted effects in other organs.

With regulatory discussions progressing and approvals already received in some regions, Agomab is preparing for the next stage of clinical development as it works toward bringing a potential treatment option to patients living with Fibrostenosing Crohn’s Disease.

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