• 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
  
  

OSE Immunotherapeutics SA  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.

Lusvertikimab (OSE127) phase 2 Proof of Concept study vs Placebo in Patients with Moderate to Severe Active Ulcerative Colitis (NCT04882007-CoTikiS):

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, lost response, or were intolerant to previous treatment(s)*. Primary endpoint was the efficacy assessment of Lusvertikimab versus placebo on the reduction of the Modified Mayo score** at week 10.

Primary endpoint**: a significant decrease of the Modified Mayo Score (MMS) is achieved versus placebo at week 10:

The 850 mg group (n=50, Placebo n=49) in the principal analysis obtained significant results at week 10 versus Placebo on the improvement of the MMS with a -0.82 (95%CI: -1.63. -0.01) difference^µ in treatment effect between lusvertikimab and placebo (p=0.047).

The 450 mg group (n=35, Placebo n=49) obtained significant results versus placebo (the 450 mg group was considered as exploratory as prematurely interrupted***) with a difference^µ of -1.17 (95%CI: -2.18; -0.16) between lusvertikimab and placebo (p=0.023).

The global treatment effect is significant considering the 450+850mg groups together versus placebo showing a difference^µ of -0.88 (95%CI: -1.64; -0.12) between lusvertikimab and placebo (p= 0.024).

Safety results: no safety signal was reported by the Data Safety Monitoring Board during the trial. Both doses of lusvertikimab show favorable safety profile in comparison with placebo, with similar rates of adverse events across the 3 treatment groups.

* Previous corticosteroids, Immunosuppressive agents or previous biological treatments

** Ulcerative Colitis is a chronic inflammatory disease of the rectum and colon characterised by mucosal inflammation, abdominal pain associated with symptoms and frequency of diarrhoea and rectal bleeding. The moderate to severe UC is measured by a Modified Mayo Score (MMS)between 4 and 9, inclusive. The primary endpoint is the mean change at Week 10 from baseline in the Modified Mayo Score, a Disease Activity Index for UC defined by the addition of the stool frequency and the rectal bleeding sub-scores (two patient’s clinical elements as Patient Reported Outcomes) and the endoscopic sub-score (mucosal endoscopy activity), assessed by an endoscopist through a central reading platform.

^µ Least Square Mean Difference between lusvertikimab and placebo=difference between groups of the Mean change in MMS between baseline and W10 (Analysis of Covariance model)

*** An interim Futility analysis performed early (33% of patients) by the IDMC proposed interruption of the 450 mg group for risk of futility but not confirmed at final analysis. The 850 mg group was hence considered as primary analysis.