A randomized Phase II study of efmarodocokin alfa, an interleukin-22 agonist, versus vedolizumab in patients with ulcerative colitis
Clinical Gastroenterology and Hepatology 2025;23:1387–1397 doi: 10.1016/j.cgh.2024.11.013
Danese et al. observed that efmarodocokin alfa did not demonstrate efficacy compared to the PBO, and this Phase II study ended early for futility; however, there was evidence of target engagement (skin AEs, regenerating islet derived protein 3-alpha).
Authors explored the therapeutic potential of efmarodocokin alfa compared to vedolizumab in patients with UC. Danese et al. characterized the efficacy, safety, PK, and PD of efmarodocokin alfa compared with PBO in individuals with UC, demonstrating evidence of target engagement and treatment-related improvement in UC-associated microbial dysbiosis.
