(CercleFinance.com) – OSE Immunotherapeutics today announces the end of recruitment in the Phase 2b clinical trial evaluating the IL-7 receptor antagonist monoclonal antibody Lusvertikimab (OSE-127) in patients with ulcerative colitis hemorrhagic disease (UC), a study promoted and conducted by OSE Immunotherapeutics.
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).
Nicolas Poirier, CEO of OSE Immunotherapeutics, said: ‘We are very pleased with the end of recruitment in Phase 2 evaluating Lusvertikimab in ulcerative colitis, a major milestone for the Company and the development of the product. We are now awaiting the main results of this efficacy study expected in the next 6 months to confirm the potential of Lusvertikimab as an innovative first-in-class therapeutic option in a chronic and debilitating inflammatory bowel disease. Positive results of clinical efficacy of Lusvertikimab in ulcerative colitis in mid-2024 could also provide a strong catalyst in the coming months and energize the presence of OSE in this growing area of chronic inflammation’.
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