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France-based OSE Immunotherapeutics’ (OSE) Phase II CoTikiS study of lusvertikimab has met primary and secondary endpoints, showing high rates of clinical and endoscopic remission after ten weeks in patients with ulcerative colitis (UC).
The placebo-controlled CoTikiS study (NCT04882007) examines the company’s primary UC therapy, lusvertikimab (OSE-127), in a 50-week long study comprising two dosing regimens and a ten-week induction period.
Patients were split into two treatment arms, with one receiving 450mg of lusvertikimab and another being given 850mg, both administered via infusions every four weeks. Using a modified Mayo Score to track disease activity, the 450mg group saw a 1.16-point drop in disease activity while the 850mg group saw a 0.9-point drop, meeting the trial's primary endpoint.
Pooled results from both the 450mg and 850mg arms saw a 16% clinical remission rate against 4% in the placebo arm, as well as an endoscopic improvement rate of 32%—both secondary endpoints in the CoTikiS study.
OSE’s lusvertikimab is described as a monoclonal antibody therapy designed to inhibit the interleukin-7 receptor (IL-7R), typically responsible for the development of immune disorders, by targeting specific cytokines. Now, the company plans to unveil the ten-week results from the ongoing trial at the 20th annual European Crohn’s and Colitis Organisation (ECCO) congress.
Arnaud Bourreille, coordinating investigator of the CoTikiS study, said: “These full Phase II clinical induction results provide strong efficacy data for lusvertikimab in UC, particularly highlighting the meaningful achievement in the key endpoints of endoscopic remission and histological improvement after only ten weeks of treatment.
“The latest data showing high histo-endoscopic mucosal improvement (HEMI) and mucosal healing rates represent a strong signal of efficacy, as they are associated with the prediction of long-term prevention of future relapse and are important for UC patients in need of breakthrough therapeutic options and sustained healing.”
As well as the primary and secondary endpoint, the trial is investigating an exploratory endpoint assessing the efficacy of lusvertikimab with severe active UC with high baseline faecal calprotectin (FCP), a marker of inflammation used to predict endoscopic response. After ten weeks, baseline FCP was not different between treatment groups, but both saw a 69.5% gain over placebo.
The announcement comes just days after Johnson and Johnson’s (J&J) fully subcutaneous Tremfya (guselkumab) saw a second round of success in a UC trial with 27.6% of patients achieving clinical remission by the end of Phase III.