OSE Immunotherapeutics SA announced that the trial's Independent Drug Safety Monitoring Board (DSMB) provided a positive recommendation on the continuation until its completion of the Phase 2 clinical trial of IL-7 Receptor (IL-7R) antagonist Lusvertikimab (OSE-127) in ulcerative colitis. In parallel, the European Medicines Agency (EMA) provided a positive opinion on Orphan Drug Designation for Lusvertikimab for the treatment of Acute Lymphoblastic Leukemia (ALL). The ongoing Phase 2 clinical trial sponsored by OSE Immunotherapeutics is evaluating the efficacy and safety of Lusvertikimab ("OSE-127") versus placebo in patients with moderate to severe active UC who failed or lost response or were intolerant to previous treatment(s) (CoTikiS trial: NCT04882007).

A positive interim futility analysis was observed in the prespecified first 50 patients (i.e., 33% of the total patient enrollment in the study) having completed the induction phase. The upcoming major milestone for this Phase 2 clinical trial is expected in the following months with the top-line results after the induction phase (primary endpoint at week 10) and in first quarter 2024 for the first early assessment in maintenance after 6 months of therapy. UC is a debilitating and chronic inflammatory bowel disease which affects 3.3 million patients in US, Europe and Japan(1), representing 12.2 per 100,000 people by year (2).

Despite broad available options, remission rates remain only 25-30% (3), leaving most patients without satisfactory treatments. EvaluatePharma Updated Incidence and Prevalence of Crohn's Disease and Ulcerative Colitis in Olmsted County, Minnesota (1970-2011).oftus EV et al. October 2014).

Drugs Context. 2019.