A significantly greater proportion of patients with moderate to severe ulcerative colitis achieved clinical remission at 32 weeks with Ozanimod 1 mg versus placebo.
Detailed results from the maintenance phase of the TOUCHSTONE phase 2 clinical trial of Ozanimod, an investigational compound, in patients with moderate to severe ulcerative colitis were announced at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Honolulu. In this clinical trial, a significantly greater proportion of patients on Ozanimod achieved or maintained clinical remission at 32 weeks compared with those on placebo.
About Ulcerative Colitis
Ulcerative colitis is a chronic, relapsing condition triggered by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon). Symptoms usually develop over time, rather than suddenly. The disease can be debilitating and can sometimes lead to life-threatening complications. Ulcerative colitis is the most common form of inflammatory bowel disease worldwide. About one in every 198 people in Europe and one in every 402 people in North America have ulcerative colitis. New therapies are needed to improve the outcomes of those impacted by this disease.
The TOUCHSTONE trial evaluated the effectiveness and safety Ozanimod compared with placebo after eight weeks of treatment (induction phase) 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.
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 achieved or maintained clinical remission at week 32 compared with only 6 percent on placebo. Mucosal improvement was also significantly more likely with Ozanimod than with placebo at week 32: 33% vs 12%.
About the Trial
TOUCHSTONE is a phase 2, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Ozanimod (also known as RPC1063) with placebo in patients with moderate to severe active ulcerative colitis. A total of 197 patients were randomized and treated once daily with 1 mg Ozanimod (n=67), 0.5 mg Ozanimod (n=65) or placebo (n=65) for 8 weeks (the induction phase). The primary endpoint was the proportion of patients in remission (Mayo score ≤2, no subscore >1) at week 8. Secondary endpoints were the proportion of patients achieving clinical response (reduction in Mayo score of ≥3 and ≥30% with a decrease in the rectal bleeding score of ≥1 or a rectal bleeding score ≤1), proportion of patients with mucosal improvement (endoscopy score ≤1), and the change in Mayo score. Safety assessments included ECG, Holter monitoring, pulmonary function testing, optical coherence tomography and AEs.
For the maintenance phase, patients who achieved a clinical response at week 8 continued with their original treatment through week 32.
Ozanimod is a orally administered small molecule sphingosine 1-phosphate 1 and 5 receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis and inflammatory bowel disease. Treatment with S1P receptor modulators is believed to work by interfering with S1P signaling 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. Ozanimod is an investigational compound that is not approved for any use in any country.
Reference: Hanhauer S, Feagan B, Wolf D, et al. A Randomized, Double-Blind, Placebo-Controlled Trial of Ozanimod, an Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative Colitis: Results of the Maintenance Period of the TOUCHSTONE Study. Abstract 19. Presented at the Annual Scientific Meeting of the ACG, October 19-21, 2015.