OSE Immunotherapeutics today announced enrolment of the first patient in its Phase 2 clinical trial evaluating the benefits of anti-IL-7 receptor antagonist OSE-127/S95011 for moderate to severe active ulcerative colitis patients.
Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: “The first patient enrolled in the Phase 2 trial marks a major step in the clinical development of OSE-127/S95011. This study is based on a firm foundation with encouraging Phase 1 results and novel and differentiated mechanism of action of OSE-127/S95011, the only full-antagonist of IL-7R. We look forward to confirming the product’s efficacy in the large population of patients suffering from ulcerative colitis, a debilitating and chronic inflammatory bowel disease representing 12.2 per 100,000 people by year. “
The first patient has been enrolled in the randomized, double-blind Phase 2 clinical trial aiming at assessing the efficacy and the safety of OSE-127/S95011 versus placebo in patients with moderate to severe active ulcerative colitis who have previously failed or lost response or are intolerant to previous treatment(s).
The study population (patients with moderate to severe ulcerative colitis who have failed or are intolerant to immunosuppressors, anti-tumor necrosis factor (TNF)-α, anti-integrin, ustekinumab
and/or corticosteroids) was selected since this population consists of patients who are in need of alternative new therapies to avoid for as long time as possible the complications linked to the disease and in whom the safety profile of OSE-127/S95011 can be reliably assessed.
Patricia Belissa-Mathiot, Director of clinical development and R&D Chief Medical Officer at Servier, concludes: “We are very pleased with the progress achieved with OSE-127/S95011, now at the
Phase 2 stage in ulcerative colitis under OSE’s sponsorship. On our side, Servier has received clinical trial authorization from the French, Spanish, U.S., U.K, Hungarian, German and Australian health agencies to initiate in parallel a Phase 2 study with OSE-127/S95011 in patients with Sjögren’s syndrome. Our R&D team is actively preparing this step, which is anticipated to start shortly.”
OSE-127/S95011 is being developed in partnership with Servier under an option agreement up to the completion of both Phase 2 clinical studies and exercise of the option upon successful completion of at least one of these Phase 2 trials. The Phase 2 in ulcerative colitis is being conducted under OSE Immunotherapeutics’ sponsorship while in parallel, another Phase 2 in Sjögren’s syndrome is planned to start shortly under Servier’s1 sponsorship.