OSE Highlights Positive Mid-Stage Results for Lusvertikimab in Ulcerative Colitis

OSE Immunotherapeutics has released early results from a Phase II clinical trial of their experimental IL-7 receptor antagonist, lusvertikimab, indicating promising efficacy for patients with ulcerative colitis (UC). According to CEO Nicolas Poirier, these results suggest that lusvertikimab could be a pioneering treatment option for UC patients who consistently require new therapeutic alternatives.

The CoTikiS study involved 136 patients suffering from moderate-to-severe active UC, who had either not responded to or could not tolerate previous treatments. Participants were divided into two groups: one received 850 mg of lusvertikimab or a placebo, while the other received 450 mg of the drug or a placebo. The study's primary endpoint was to observe changes in the Modified Mayo Score (MMS), a measure of UC activity, by the 10th week.

Significant improvements in disease activity were noted. Patients administered the higher 850 mg dose of lusvertikimab saw a notable reduction in MMS at 10 weeks compared to the placebo group. This was demonstrated by a treatment effect difference of -0.82. The group receiving 450 mg of the drug also showed substantial improvements, with a treatment effect difference of -1.1, although this result is considered preliminary due to an early termination of this part of the study. When combining both dosages, the overall treatment effect difference was -0.88 in favor of lusvertikimab over the placebo, which was statistically significant.

Regarding safety, OSE Immunotherapeutics reported that lusvertikimab exhibited a favorable safety and tolerability profile. This positive safety data was consistent during a six-month open-label extension phase of the study. More detailed safety and efficacy findings are expected to be shared at upcoming medical conferences.

Beyond its application in UC, lusvertikimab is also being evaluated in mid-stage clinical trials for primary Sjögren’s syndrome in partnership with Servier. Additionally, the drug has shown promising preclinical efficacy in treating acute lymphoblastic leukemia, again in collaboration with Servier.