Celgene Corporation, a biopharmaceutical company focused on the development of innovative therapies for cancer and immune-inflammatory related diseases, recently announced the results of the “maintenance phase” of its Phase 2 clinical trial TOUCHSTONE, assessing the company’s investigational drug Ozanimod in patients with ulcerative colitis. The results were presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Honolulu, Hawaii.
Ozanimod (RPC1063) is a sphingosine 1-phosphate 1 and 5 receptor modulator under development for conditions like relapsing multiple sclerosis and inflammatory bowel disease (IBD), including ulcerative colitis, a chronic, relapsing disorder triggered by an abnormal immune response that induces a long-lasting inflammation in the mucosa of the large intestine. It is estimated that 1 in every 402 individuals in North America suffer from ulcerative colitis. Modulators of S1P receptor are thought to interfere with the immune response of lymphocytes (a type of white blood cell), sequestering them within lymph nodes and preventing them from participating and contributing to autoimmune reactions.
The randomized, double-blind, placebo-controlled TOUCHSTONE Phase 2 trial assessed the safety and efficacy of Ozanimod in 197 patients with moderate to severe active ulcerative colitis for a period of 8 weeks (induction phase). Participants who achieved a clinical response during this period (103 patients) continued their treatment up to week 32.
Previously, the team reported that a significant proportion of patients achieved remission at week 8, meeting the trial’s primary endpoint. Researchers reported that after 32 weeks of treatment, a significantly greater proportion of patients under Ozanimod therapy achieved or maintained clinical remission (21%) in comparison to patients in the placebo group (6%). Patients under Ozanimod treatment also exhibited mucosal improvement and greater clinical response in comparison to placebo.
“Along with the previously reported results from the induction phase of this trial, data from the maintenance phase suggest that orally administered Ozanimod has the potential to help patients with moderate to severe ulcerative colitis,” said Dr. Stephen Hanauer, Medical Director, Northwestern Medicine Digestive Health Center, and Professor of Medicine-Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, in a press release.
In terms of safety, the most common adverse events were worsening of the ulcerative colitis and urinary tract infection. No serious adverse events were reported.
“Ozanimod has the potential to offer a novel oral therapeutic approach for patients with ulcerative colitis, who need new therapies,” concluded the President of Celgene Inflammation & Immunology, Scott Smith. “We are pleased with these safety and efficacy results, which give us confidence as we move forward with our phase 3 clinical trial.”