OSE Immunotherapeutics is hoping to show Servier what they walked away from. Around one year after the French drugmakers split up, the biotech has reported midphase data on an anti-IL-7 antibody lusvertikimab in ulcerative colitis showing a potential improvement in symptoms.
The phase 2 CotiKis results allowed OSE to claim victory but fell short of a comprehensive, clear-cut win. Investigators enrolled 136 people with moderate to severe active ulcerative colitis who were failed by existing drugs such as corticosteroids, immunosuppressive agents and biologics. Participants received placebo or one of two doses of lusvertikimab and were assessed on the composite Mayo symptom score, which measures disease activity, after 10 weeks.
An independent committee proposed interrupting the low, 450 mg dose for risk of futility after analyzing data on the first 33% of participants. OSE said the interruption was premature, pointing to a p value of 0.023 in the low-dose arm. The analysis was considered exploratory because of the interruption.
The situation led OSE to consider the high, 850 mg dose cohort to be the primary analysis. In that group of 99 patients, OSE saw a 0.82 placebo-adjusted reduction in the average Mayo score, resulting in a p value of 0.047. The placebo-adjusted change in the low-dose cohort was 1.17. Combining the arms, OSE reported a placebo-adjusted reduction of 0.88 and a p value of 0.024.
OSE continued to track patients for 34 weeks in an open-label extension but is yet to share data from that period of the study, only saying it saw a “reinforced efficacy signal.” Similarly, the biotech is yet to provide a breakdown of the composite Mayo endpoint. OSE highlighted endoscopic improvement as a highlight without providing numbers or commenting on the other measures that made up the endpoint. The press release lacks data on secondary endpoints such as the rate of clinical remission.
On the safety front, OSE said both doses showed a favorable safety profile compared to placebo, with similar rates of adverse events across the three treatment groups. The biotech plans to share full data at future medical congresses.
OSE advanced lusvertikimab in ulcerative colitis based on evidence that IL-7 is implicated in severe cases that are unresponsive to conventional or biologics therapies. High expression of the receptor is linked to poor responses to anti-TNF therapies such as Humira.