OSE Immunotherapeutics Reports Positive Phase 2 Results for Lusvertikimab in Ulcerative Colitis

NANTES, France, July 24, 2024 – OSE Immunotherapeutics SA announced promising initial results from its CoTikiS Phase 2 study of Lusvertikimab, a pure antagonist of the IL-7 receptor. This randomized, double-blind, placebo-controlled Proof of Concept trial indicated significant efficacy in treating ulcerative colitis, as evidenced by an improvement in the Modified Mayo Score (MMS) at the 10-week primary endpoint of the treatment induction phase. Additionally, a favorable safety profile was noted during both the induction phase and a subsequent 6-month open-label extension phase.

According to Nicolas Poirier, CEO of OSE Immunotherapeutics, "We are thrilled to present these Phase 2 efficacy results for Lusvertikimab in ulcerative colitis, a chronic, debilitating inflammatory bowel disease. This trial underscores Lusvertikimab's potential as a first-in-class treatment with a unique mechanism of action as an IL-7 pure antagonist. These positive clinical results bolster future opportunities and strengthen OSE’s position in the growing field of chronic immune inflammation."

Frédérique Corallo, Chief Medical Officer for Immuno-Inflammation, expressed gratitude towards the trial participants and the global team for their dedication. Corallo highlighted the efficacy of Lusvertikimab at two doses tested over ten weeks, particularly noting endoscopic improvements. The extension phase up to 34 weeks reinforced the efficacy signals, and a good safety profile was observed across the patient population. Full data will be presented at upcoming medical conferences.

The CoTikiS study evaluated Lusvertikimab’s efficacy and safety in 136 patients with moderate to severe active ulcerative colitis who had either failed, lost response, or were intolerant to previous treatments, including corticosteroids, immunosuppressive agents, or biological treatments. The primary endpoint was the reduction of the Modified Mayo Score at 10 weeks.

In terms of efficacy, the 850 mg group (n=50, Placebo n=49) showed a significant improvement in MMS compared to placebo, with a treatment effect difference of -0.82 (95%CI: -1.63 to -0.01; p=0.047). The 450 mg group (n=35, Placebo n=49) also demonstrated significant results, with a difference of -1.17 (95%CI: -2.18 to -0.16; p=0.023). When combining the 450 mg and 850 mg groups, the overall treatment effect remained significant, with a difference of -0.88 (95%CI: -1.64 to -0.12; p=0.024).

Regarding safety, the Data Safety Monitoring Board did not report any safety signals during the trial. Both doses of Lusvertikimab exhibited a favorable safety profile compared to placebo, with similar adverse event rates across all treatment groups.

The study's primary endpoint was defined as the mean change from baseline in the Modified Mayo Score at Week 10. The MMS is a Disease Activity Index for ulcerative colitis, combining stool frequency, rectal bleeding, and endoscopic sub-scores assessed by an endoscopist through a central reading platform. The least square mean difference between Lusvertikimab and placebo groups was used to measure the efficacy.

OSE Immunotherapeutics is a biotech company focusing on developing first-in-class assets in immuno-oncology and immuno-inflammation. The company aims to generate significant value from its proprietary drug discovery platforms, which are central to its goal of delivering next-generation immunotherapies.