OSE Immunotherapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial Evaluating Lusvertikimab in Patients with Ulcerative Colitis

Regulatory News:

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) announced today the completion of patient enrollment in the Phase 2b clinical trial evaluating anti-IL-7 receptor monoclonal antibody Lusvertikimab (OSE-127) in patients with moderate to severe active Ulcerative Colitis (UC). The study, (CoTikiS trial: NCT04882007), is sponsored and conducted by OSE Immunotherapeutics.

The purpose of the randomized, double-blind Phase 2 clinical trial CoTikiS is to evaluate the efficacy and safety of Lusvertikimab (OSE-127) versus placebo in patients with moderate to severe active UC who are naïve of treatment or who previously failed, lost response, or were intolerant to previous treatment(s). An interim futility analysis was successfully conducted in the prespecified first 50 patients (i.e. 33% of the total patient enrollment in the study), who completed the induction phase. Top-line efficacy results after the induction phase (primary endpoint at week 10) and the first early assessment after six months of therapy in open-label extension are expected in the next months (mid-2024).

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented: “We are very pleased to complete the enrollment for the Phase 2 evaluation of Lusvertikimab in ulcerative colitis, a major milestone for the Company and the product’s development. We are grateful to the investigators and patients for their commitment to this study. We now look forward to the Phase 2 top-line readouts expected in the next six months to confirm the potential of Lusvertikimab as an innovative first-in-class novel therapeutic option for a disabling chronic inflammatory bowel disease. The recent announcement of our global partnership with AbbVie for a preclinical program illustrates the quality of our research in the field of inflammation. Potential positive clinical efficacy results of Lusvertikimab in ulcerative colitis by mid-2024 could also generate a strong catalyst in the coming months and enhance OSE's presence in this growing field of chronic inflammation.”

UC is a debilitating and chronic inflammatory bowel disease that affects 3.3 million patients in the US, Europe, and Japan ⁽¹⁾, which represents 12.2 per 100,000 people every year ⁽²⁾. The global inflammatory bowel disease market is expected to grow to $27 billion in 2028, with $10 billion designated for UC ⁽¹⁾. Despite broad options, remission rates are only 25-30% ⁽³⁾, leaving most patients without satisfactory treatments. The preclinical and translational research conducted by OSE and collaborators illustrated that the IL-7 receptor pathway is highly upregulated in the gut mucosa of patients suffering from moderate to severe UC or Crohn’s disease and that Lusvertikimab could control colon inflammation in humanized colitis preclinical models or inflamed colon biopsies from UC patients grown ex-vivo ⁽⁴⁾.