OSE Immunotherapeutics has a broad pipeline, spanning oncologic and immunologic indications, but one of its two lead assets is the anti-interleukin (IL)-7R monoclonal antibody, lusvertikimab.
The company recently presented results from its Phase II CoTikiS trial of the first-in-class drug in moderate to severe ulcerative colitis patients, at the 20th Congress of the European Crohn’s and Colitis Organization, in which the drug met its primary and secondary endpoints after a 10-week induction phase.
Specifically, both the 450mg and 850mg doses met the primary endpoint of improving the Modified Mayo Score at week 10, with differences versus placebo of -1.16 (p=0.019) and -0.9 (p=0.036) points, respectively. Key secondary endpoints showed meaningful improvements, including a clinical remission rate of 16% for the pooled dose group versus 4% for placebo (odds ratio: 4.25, p=0.066) and an endoscopic improvement rate of 32% versus 13% for placebo (odds ratio=3.29, p=0.027).
In patients with severe UC and high baseline fecal calprotectin (FCP >250 μg/g), lusvertikimab significantly decreased FCP levels after 10 weeks, with the pooled dose group showing a difference of -1,048 μg/g versus placebo (p=0.011). Among these patients, 42% in the pooled dose group achieved FCP normalization (below 250 μg/g), compared to 18% in the placebo group (p=0.02). Histological improvements were also notable, with 37% of patients in the pooled dose group achieving a Nancy Histological Index score ≤1, compared to 10% of placebo recipients (p<0.01). The drug demonstrated a favorable safety profile with no significant differences in adverse events between treatment groups and placebo.
In Vivo spoke with CEO Nicolas Poirier about the asset, the Phase II results, development and commercialization plans for lusvertikimab, precision medicine and the future of therapy for patients with IBD.
Timestamps:
Intro
1:25 - CEO Nicolas Poirier on OSE’s broad pipeline picture
2:45 - Lusvertikimab’s mechanism of action and differentiation from other treatments for ulcerative colitis
3:50 - Recent data from the European Crohn’s and Colitis Organization’s 20th Congress
5:10 - Efficacy in patients with high fecal calprotectin, and significance of this finding
6:35 - Combination treatment potential with IL-23 inhibitors, but current focus on monotherapy
8:50 - Other indications for lusvertikimab and development strategy
10:30 - Funding needed to move to Phase III
11:45 - Commercialization strategy for lusvertikimab and OSE’s other lead asset
13:00 - The future of IBD: breaking the therapeutic ceiling in IBD through combo treatments and precision medicine using biomarkers
