OSE Immunotherapeutics presented full efficacy and safety data from the induction period of the Phase 2 CoTikiS study of Lusvertikimab (OSE-127) in patients with moderate to severe active ulcerative colitis (UC) at the 20th Congress of ECCO. The results demonstrated meaningful efficacy and a favorable safety profile.
The CoTikiS study is a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Lusvertikimab versus placebo in 136 patients with moderate to severe active UC who had failed or lost response to previous treatments. The study included a 10-week induction period, a 24-week open-label extension period (OLE), and a 16-week safety follow-up period.
Key Findings from the CoTikiS Study
The overall induction results from the CoTikiS study revealed that both doses of lusvertikimab (450 mg and 850 mg) met the primary efficacy endpoint, demonstrating a statistically significant improvement in the Modified Mayo Score at week 10.
Significant improvements were also observed in key secondary endpoints:
- Clinical remission rate: 16% for the pooled 450+850 mg group versus 4% for placebo (p=0.066).
- Endoscopic improvement rate: 32% for the pooled group versus 13% for placebo (p=0.027).
- Endoscopic remission rate: 25% for the pooled group versus 13% for placebo (p=0.120).
- Ulcerative Colitis Endoscopic Index of Severity (UCEIS) mean score change: -1.35 for the pooled group versus -0.32 for placebo (p=0.007).
- Fecal Calprotectin (FCP): -716 μg/g for the pooled group versus +189 µg/g for placebo (p=0.004).
Histological and Mucosal Improvements
Exploratory objectives included histological score analysis, which showed significant improvements in the lusvertikimab groups. Histological improvement, defined by a Nancy Histological Index (NHI) score of 0 or 1, was achieved in 37.0% of the pooled group compared to 10.0% in the placebo group (p<0.01).
Histo-Endoscopic Mucosal Improvement (HEMI), defined by a NHI score ≤ 1 and a Mayo Endoscopic score ≤ 1, was observed in 21.9% of the pooled group versus 7.5% in the placebo group (p=0.05).
Impact on Patients with High Baseline Fecal Calprotectin
In patients with high baseline FCP (> 250 μg/g), lusvertikimab significantly decreased FCP after 10 weeks of treatment. Normalization of FCP to below 250 µg/g was achieved in 42% of the pooled group versus 18% in the placebo group (p=0.02).
Clinical remission rates in this subgroup were also notable, with 16.9% in the pooled group achieving clinical remission compared to 0% in the placebo group (p<0.01).
Safety and Tolerability
Lusvertikimab demonstrated a good safety profile and was well tolerated, with no significant differences between the treatment groups and placebo in the incidence of drug-related adverse events.
Expert Commentary
Pr. Arnaud Bourreille, Coordinating Investigator of the CoTikiS study, noted that the Phase 2 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 10 weeks of treatment. He added that the 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.
Pr. Walter Reinisch commented on the significant decrease in FCP observed with lusvertikimab, highlighting its potential as an efficacious therapy for all UC patients by normalizing increased baseline FCP values.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease affecting millions worldwide, characterized by inflammation and ulcers in the lining of the colon and rectum. Despite available treatments, a significant proportion of patients do not achieve satisfactory remission, underscoring the need for novel therapeutic options.
About Lusvertikimab
Lusvertikimab is a first-in-class anti-IL-7R antibody being developed by OSE Immunotherapeutics for the treatment of ulcerative colitis and other autoimmune diseases. It selectively inhibits the IL-7 pathway, which plays a key role in the activation and survival of pathogenic T lymphocytes in tissues.
