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

Favorable safety and tolerability profile maintained through up to 60 weeks of treatment with ontunisertib in Fibrostenosing Crohn’s disease (FSCD) patients Low annualized FSCD-related event rate of 3%, with one endoscopic balloon dilation (EBD) and no surgeries reported over the full treatment period Radiological assessment shows trend for fibrotic stricture stabilization over treatment course Sustained