OSE Immunotherapeutics SA announced 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, 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). UC is a debilitating and chronic inflammatory bowel disease that affects 3.3 million patients in the US, Europe, and Japan, which represents 12.2 per 100,000 people every year.

The global inflammatory bowel disease market is expected to grow to $27 billion in 2028, with $10 billion designated for UC. Despite broad options, remission rates are only 25-30%, 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.