Celgene announces maintenance results for Ozanimod in ulcerative colitis

Celgene has announced detailed results from the maintenance phase of the TOUCHSTONE Phase 2 clinical trial of Ozanimod in patients with moderate to severe ulcerative colitis.

Ozanimod is a small molecule sphingosine 1-phosphate 1 and 5 receptor modulator. Treatment with S1P receptor modulators is believed to work by interfering with S1P signalling and blocks the response of lymphocytes (a type of white blood cell) to exit signals from the lymph nodes, sequestering them within the nodes. The result is thought to be a downward modulation of circulating lymphocytes and anti-inflammatory activity by inhibiting cell migration to sites of inflammation.

In the trial, a significantly greater proportion of patients on Ozanimod achieved or maintained clinical remission at 32 weeks compared with those on 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.

Results give Celgene confidence for Phase 3 trial of Ozanimod

The TOUCHSTONE trial 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 ulcerative colitis. 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 in the 8-week induction phase.

For the maintenance phase, 103 patients who achieved a clinical response at week 8 continued with their original treatment for an additional 24 weeks; of these, 91 patients completed 32 weeks of treatment.

Twenty one percent of patients on Ozanimod 1 mg achieved or maintained clinical remission at week 32 compared with 6 percent on placebo.  Clinical response at week 32 was achieved or maintained by 51 percent and 20 percent of patients, respectively. Mucosal improvement was also significantly more likely with Ozanimod 1 mg than with placebo at week 32.

“Ozanimod has the potential to offer a novel oral therapeutic approach for patients with ulcerative colitis, who need new therapies,” said Scott Smith, President, Celgene Inflammation & Immunology. “We are pleased with these safety and efficacy results, which give us confidence as we move forward with our Phase 3 clinical trial.”