Agomab Initiates Phase 2b NOV-ERA Study for FSCD Treatment

Agomab announced the design of its upcoming Phase 2b NOV-ERA study with ontunisertib, its investigational oral gastro-intestinal-restricted small molecule inhibitor of ALK5 for the potential treatment of Fibrostenosing Crohn's Disease, or FSCD. The company has aligned with the FDA on the study design of NOV-ERA, including the study's primary efficacy endpoint of endoscopic passability at Week 24 as assessed by the SES-CD narrowing score, as well as several secondary efficacy endpoints relevant to patients with FSCD. The protocol has been submitted to the FDA and has cleared central Institutional Review Board approval in the U.S. In addition, the study has received approval by Health Canada. The company has also submitted Clinical Trial Applications in multiple countries globally, including in the European Union and Asia Pacific territories. The company expects to initiate the NOV-ERA study following receipt of applicable regulatory and ethics approvals and plans to dose the first participants in the second half of 2026. The planned 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 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. Upon study initiation, participants will be randomized in a 1:1:1:1 ratio to receive either ontunisertib at one of three dose levels, 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.