Celgene: Open-label Touchstone extension study showed symptom improvement
Celgene International Sarl announced that data from the open-label extension of the TOUCHSTONE phase 2 clinical trial of ozanimod in patients with moderate to severe ulcerative colitis are to be presented at the United European Gastroenterology Week in Vienna, Austria and at the American College of Gastroenterology Annual Scientific Meeting in Las Vegas. Ozanimod is an investigational selective S1P 1 and 5 receptor modulator. TOUCHSTONE evaluated the efficacy and safety of 0.5 mg and 1 mg doses of ozanimod compared with placebo after eight weeks of treatment in 197 patients with moderate to severe active ulcerative colitis. Patients who achieved a clinical response at week 8 continued with their original treatment through week 32 in a maintenance phase. The primary endpoint was the proportion of patients in remission at week 8. Secondary endpoints were: the proportion of patients achieving a clinical response, the proportion of patients with mucosal improvement and the change from baseline in Mayo score. Previously reported results showed TOUCHSTONE met its primary endpoint and secondary endpoints with statistical significance for patients on the 1 mg dose of ozanimod versus placebo. TOUCHSTONE participants in all three treatment arms entered the open-label extension if they did not respond to treatment after the induction phase, relapsed during the maintenance phase or completed the maintenance phase The objective of the open-label extension phase is to evaluate the long-term efficacy and safety of daily ozanimod 1 mg. Treatment with ozanimod 1 mg in the extension phase also showed a decrease in the proportion of patients with rectal bleeding and moderate or severe diarrhea. "Findings from this extension study at week 44 showed improvements in efficacy measures for patients who took ozanimod throughout both the blinded study and the extension," said Scott Smith, President, Celgene Inflammation & Immunology. "We recognize the strong need for innovative treatments that help patients with inflammatory bowel disease achieve durable results. We are committed to advancing additional transformational oral treatment options for these patients."