Nantes, France – March 18, 2024, 7:30 a.m. – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announces the end of recruitment in the Phase 2b clinical trial evaluating the monoclonal antibody antagonist of the IL-7 Lusvertikimab (OSE-127) in patients with ulcerative colitis (UC), a study sponsored and conducted by OSE Immunotherapeutics (CoTikiS trial: NCT04882007).
The Phase 2 CoTikiS study, randomized, double-blind versus placebo, evaluates the efficacy and safety of Lusvertikimab versus placebo in patients with moderate to severe active UC, naïve to any treatment or after failure, loss of response or intolerance to previous treatment(s). An interim futility analysis was successfully conducted in the first 50 patients (33% of the total number of patients planned in the study) who completed the induction phase of the trial. The first efficacy results post-induction phase (primary endpoint at week 10) and a first evaluation after 6 months of treatment in the open-label extension phase are expected in the coming months (mid-2024).