Agomab Therapeutics NV, a clinical-stage biopharmaceutical company focused on fibro-inflammation, has 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).
Approximately 46% of Crohn’s disease patients have FSCD, or fibrotic strictures in the intestinal tract, which can cause obstructive symptoms leading to dietary change, malnutrition and surgery.
Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD.
The NOV-ERA study breaks new ground as the first Phase 2b study in FSCD, an area of high unmet medical need, and will inform dose selection and pivotal endpoints. The submission of the study protocol to key regulatory agencies is a crucial milestone in the late-stage development of ontunisertib in FSCD. We are now focused on completing operational preparations and look forward to initiating patient enrollment in the coming months.
Philippe Wiesel, MD, Chief Medical Officer of Agomab
The planned NOV-ERA study is a randomised, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with symptomatic FSCD. The trial is expected to enroll up to 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 a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD).
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. The trial will consist of a 6-week screening period, a 52-week treatment period, and a 2-week follow-up period.
The endpoints assessed in the NOV-ERA study are designed to inform the selection of potential registrational endpoints for ontunisertib in FSCD.
Ontunisertib is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.
Crohn’s disease is a chronic progressive disease of the gastrointestinal tract. It is estimated that approximately 46% of patients with Crohn’s disease have fibrosis of the gastrointestinal tract, resulting in stricture formation and intestinal obstructions, most frequently in the terminal ileum.
These strictures can cause obstructive symptoms leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are no approved pharmacological therapies for FSCD.
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.
