OSE Immunotherapeutics Announces Positive Efficacy Results for Lusvertikimab in the Phase 2 trial for the treatment of Ulcerative Colitis

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OSE Immunotherapeutics
OSE Immunotherapeutics

OSE Immunotherapeutics Announces Positive Efficacy Results for Lusvertikimab in the Phase 2 trial for the treatment of Ulcerative Colitis

  • Lusvertikimab demonstrates significant efficacy during the 10 week-induction phase of treatment, in the randomized double-blind CotiKis phase 2 study

  • Favorable safety and tolerability profile in the whole patient population across the two doses tested and during the open label phase of treatment

  • First anti-IL7R mAb positive efficacy study enabling pathway of future development to potential First-in-Class Interleukin-7 antagonist

NANTES, France, July 24th, 2024 – 7:30 am CET- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today reported first positive results from its CoTikiS randomized, double-blind, placebo-controlled, Proof of Concept phase 2 study of Lusvertikimab, a pure antagonist of IL-7 receptor, demonstrating significant efficacy results measured by the improvement of the Modified Mayo Score** (at week 10 primary endpoint of the treatment induction phase). A favorable safety profile was observed during both the induction phase and during the 6 months of open-label extension phase trial.

Nicolas Poirier, Chief Executive Office of OSE Immunotherapeutics, comments: “We are very excited to share these first positive Phase 2 efficacy results for Lusvertikimab in ulcerative colitis, a disabling chronic relapsing inflammatory bowel disease with a patient population in regular need of alternative new therapies. This clinical proof of concept study establishes Lusvertikimab as a potential first-in-class with novel therapeutic options, based on its differentiated mechanism of action as a pure interleukin-7 antagonist. We are optimistic about the potential for patients, these positive clinical efficacy and safety results represent a strong catalyst for future opportunities and enhances OSE presence in this growing field of chronic Immune inflammation.

Frédérique Corallo, CMO Immuno-Inflammation commented:” We are very grateful to the patients who participated in this trial, study investigators, and the global team involved for their strong commitment to achieve this important clinical milestone”. She added “Lusvertikimab has shown very interesting efficacy results with the two doses tested at week-10, in particular on endoscopic improvement, and reinforced efficacy signal for 34 weeks in the open-label extension. A good safety profile was observed in the whole patient population. The full data set will be completed in a specific communication and presented at future medical congresses.