OSE Immunotherapeutics (ISIN:FR0012127173; Mnemo:OSE) has announced positive results from the induction period its Phase 2 study of Lusvertikimab (OSE-127), demonstrating strong efficacy and a favorable safety profile in patients with moderate to severe active ulcerative colitis (UC).
The CoTikiS Phase 2, randomized, double-blind trial assessed the safety and efficacy of Lusvertikimab versus placebo in 136 patients with moderate to severe UC who had not responded adequately to previous treatments. Spanning 50 weeks, the study featured a ten-week induction phase that assessed two doses of Lusvertikimab (450mg or 850mg) against placebo, followed by a 24-week open-label extension in which all participants received 850mg infusions every four weeks, and a 16-week treatment-free safety follow-up.
Prof. Arnaud Boureille, Associate professor in Gastroenterology, Institut des Maladies de l’Appareil Digestif, Nantes University Hospital, principal/ scientific coordination of the CoTikiS study, said, “We are very excited to share these positive topline efficacy results which could establish Lusvertikimab as a potential new breakthrough therapeutic option for UC patients.”
“We are beyond enthusiastic with the very high endoscopy efficacy and what it could mean for patients suffering from chronic ulcerative colitis. This promising drug-candidate with a differentiated mode of action and very good safety profile needs to be further actively explored in ulcerative colitis and in other indications. We are grateful to all the investigators and patients for their participation in this study and we are eager to present a more complete clinical and biomarkers data set in future medical congresses,” Prof. Boureille added.
Nicolas Poirier, CEO of OSE commented, “These impressive efficacy and safety results represent a major milestone in the clinical development of Lusvertikimab and a strong catalyst for the subsequent steps. Lusvertikimab has clearly demonstrated meaningful clinical proof-of-efficacy in UC and we are now looking forward to further evaluating it in additional studies with the ultimate goal of making this innovative therapy accessible to millions of patients in need of more efficacious and safe treatments.”
Mr. Poirier concluded, “Lusvertikimab is a pure interleukin-7 receptor antagonist mAb and we believe it has a broad first-in-class potential in various chronic inflammatory and autoimmune diseases. We look forward to making progress on this strategy and to go ahead with the most relevant partners.”
