French immunotherapy company OSE Immunotherapeutics (Euronext Paris: OSE) presented full efficacy and safety data from the induction period of the randomized, double-blind, placebo-controlled, Phase II CoTikiS study of lusvertikimab (OSE-127) at the 20th Congress of ECCO (European Crohn’s and Colitis Organization), demonstrating meaningful efficacy and a favorable safety profile in moderate to severe active ulcerative colitis (UC) patients.
The randomized, double-blind Phase II clinical trial CoTikiS evaluated the efficacy and safety of lusvertikimab versus placebo in 136 patients with moderate to severe active UC who failed or lost response to previous treatment(s).
The study showed high rates of clinical and endoscopic remission, significant improvements in tissue health, and a marked reduction in fecal calprotectin levels - a key indicator of inflammation - particularly in patients with high baseline levels. In just 10 weeks, lusvertikimab lowered fecal calprotectin by more than 1,000µg/g in patients with severe ulcerative colitis – over five times the reduction seen with placebo (p=0.011), underscoring its potential as a breakthrough therapy.
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