OSE Immunotherapeutics (ISIN:FR0012127173; Mnemo:OSE) has announced that full efficacy and safety data from the induction period of the randomized, double-blind, placebo-controlled, Phase 2 CoTikiS study of Lusvertikimab (OSE-127) in active ulcerative colitis (UC), was presented at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO).
According to OSE, results demonstrated meaningful efficacy and a favorable safety profile in moderate-to-severe UC.
In a statement, Pr. Arnaud Bourreille, associate professor in gastroenterology at the Institute des Maladies de l’Appareil Digestif, Nantes University Hospital, and coordinating investigator of the CoTikiS study, said, “These full Phase 2 clinical induction results provide strong efficacy data for Lusvertikimab in UC, particularly highlighting the meaningful achievement in the key endpoints of endoscopic remission and histological improvement after only ten weeks of treatment. The latest data showing high histo-endoscopic mucosal improvement and mucosal healing rates represent a strong signal of efficacy, as they are associated with the prediction of long-term prevention of future relapse and are important for UC patients in need of breakthrough therapeutic options and sustained healing.”
Pr. Walter Reinisch, director of the IBD Study Group at the Medical University of Vienna, Department of Internal Medicine, commented, “Lusvertikimab has been shown to significantly decrease FCP, an objective inflammatory biomarker most commonly used in clinical practice to monitor treatment response in patients with UC. These data parallel and confirm the overall results of the primary and secondary endpoints from the CoTikiS study, highlighting the potential of Lusvertikimab as an efficacious therapy for all UC patients, also by normalizing increased baseline GCP values.”
