OSE Immunotherapeutics announced today the completion of enrolment in the Phase 2b clinical trial evaluating the IL-7 receptor antagonist monoclonal antibody Lusvertikimab (OSE-127) in patients with ulcerative colitis (UC), a study promoted and conducted by OSE Immunotherapeutics.

The randomized, double-blind, placebo-controlled Phase 2 CoTikiS study is evaluating the efficacy and safety of Lusvertikimab versus placebo in patients with moderate-to-severe active UC who are treatment-naive or who have failed, lost response or intolerance to prior treatment(s).

An interim futility analysis was successfully conducted on the first 50 patients (33% of the total number of patients planned in the study) to complete the induction phase of the trial.

The first post-induction efficacy results (primary endpoint at week 10) and a first assessment after 6 months of treatment in the open-label extension phase are expected in the coming months (mid-2024).

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented: "We are very pleased to have completed enrolment in the Phase 2 trial evaluating Lusvertikimab in ulcerative colitis, a major milestone for the Company and the development of the product. We now look forward to the top-line results of this efficacy trial over the next 6 months to confirm Lusvertikimab's potential as an innovative first-in-class treatment option in this chronic and debilitating inflammatory bowel disease. Positive clinical efficacy results for Lusvertikimab in ulcerative colitis in mid-2024 could also act as a strong catalyst in the coming months, boosting OSE's presence in the growing field of chronic inflammation.

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