OSE Immuno: presents positive results in UC

(CercleFinance.com) - OSE Immunotherapeutics today announced positive results from the induction phase of CoTikiS, the randomized, double-blind, placebo-controlled Phase 2 study with Lusvertikimab (OSE-127) demonstrating strong efficacy and a favorable safety profile in moderate-to-severe active ulcerative colitis (UC).


The randomized, double-blind Phase 2 CoTikiS study assessed the efficacy and safety of Lusvertikimab versus placebo in 136 patients with moderate-to-severe active UC who had failed or lost response to prior treatment(s).

CoTikiS is a 50-week study, comprising a 10-week induction period evaluating two doses (450 mg and 850 mg) of Lusvertikimab versus placebo, followed by an additional 24-week open-label period (OLE) during which all subjects received Lusvertikimab 850 mg infusions every 4 weeks, and a 16-week treatment-free safety follow-up period.

At all doses and in all patient groups, Lusvertikimab demonstrated a favorable safety and tolerability profile during the induction period and during the additional 24 weeks of extended treatment (34 weeks in total), with no specific safety signals identified.

This is the first positive efficacy study of an anti-IL7R monoclonal antibody, paving the way for the development of a potential first-in-class IL-7 antagonist in autoimmune and inflammatory diseases", says the company.

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