A significantly greater proportion of patients with moderate to severe ulcerative colitis achieved clinical remission at 32 weeks with Ozanimod 1 mg versus placebo
Clinical response and mucosal healing also significantly improved with Ozanimod 1 mg compared to placebo at week 32
Week 32 safety results consistent with those at week 8
"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
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 (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 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 (reduction in Mayo score of ≥3 and ≥30 percent with a decrease in rectal bleeding score of ≥1 or a rectal bleeding score ≤1) continued with their original treatment for an additional 24 weeks; of these, 91 patients completed 32 weeks of treatment.
Twenty one percent (14/67) of patients on Ozanimod 1 mg achieved or maintained clinical remission at week 32 [compared with 6 percent (4/65) on placebo (p=0.0108) and clinical response at week 32 was achieved or maintained by 51 percent (34/67) and 20 percent (13/65) of patients, respectively (p=0.0002)].
Mucosal improvement was also significantly more likely with Ozanimod 1 mg than with placebo at week 32 [22/67 (32.8 percent) vs. 8/65 (12.3 percent); p=0.0046)].
Adverse events (AEs) occurred in 11/42 (26.2 percent) patients in the Ozanimod 1 mg arm, 4/36 (11.1 percent) in the Ozanimod 0.5 mg arm and 8/25 (32.0 percent) in the placebo arm. The most common AEs were worsening of ulcerative colitis (1, 0 and 2 patients, respectively) and urinary tract infection (0, 1 and 1). No AEs of special interest (cardiac, pulmonary, ophthalmologic, hepatic, malignancy or serious infection) were reported during the maintenance phase.
"Ozanimod has the potential to offer a novel oral therapeutic approach
for patients with ulcerative colitis, who need new therapies," said
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 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.
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
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