OSE Immunotherapeutics Announces Statistically Significant and Clinically Meaningful Results from the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment of Ulcerative Colitis

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OSE Immunotherapeutics
OSE Immunotherapeutics

OSE Immunotherapeutics Announces Statistically Significant and Clinically Meaningful Results from the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment of Ulcerative Colitis

  • Lusvertikimab met the primary endpoint (modified Mayo Score improvement) at each dose tested during the 10 week-induction period of treatment in the randomized double-blind CoTikiS Phase 2 study.

  • Highly favorable positive results on the key secondary endpoints demonstrating significantly high rate of clinical and endoscopic remission.

  • Across all doses and patient groups, Lusvertikimab demonstrated favorable safety and tolerability profile during the induction period and 24-week additional open label extension treatment (total of 34 weeks) with no specific safety signal identified.

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

NANTES, France, November 4th, 2024 – 7:30am CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today reported positive results from the induction period of the CoTikiS randomized, double-blind, placebo-controlled, Phase 2 study of Lusvertikimab (OSE-127) demonstrating a strong efficacy and favorable safety profile in moderate to severe active ulcerative colitis (UC).

Topline results from the CoTikiS Phase 2 Study

The randomized, double-blind Phase 2 clinical trial CoTikiS has evaluated the efficacy and the safety of Lusvertikimab versus placebo in 136 patients with moderate to severe active UC who failed or lost response to previous treatment(s)*. CoTikiS is a 50-week study, with a 10-week induction period evaluating two doses (450mg or 850mg) of Lusvertikimab against placebo, a 24-week additional open label treatment extension period (OLE) during which all subjects received Lusvertikimab 850mg infusions every 4 weeks and a 16-week safety follow-up period free of treatment.

Lusvertikimab (Lusv) met the primary efficacy endpoint defined by the improvement of the Modified Mayo Score (MMS)** at week 10 (W10) at the two doses tested and demonstrated statistically significant and clinically meaningful results on key secondary endpoints. A favorable safety profile was observed during both the induction period and during the 6 months of open-label extension period trial. 134 patients were analyzed in the W0-W10 period [group 850mg (50 patients); group 450mg (35 patients); drug group pooled 850mg + 450mg (85 patients); group placebo (49 patients)]. A total of 120 patients treated with Lusvertikimab participated to the additional 24-week OLE treatment period.