Celgene International Sàrl, a subsidiary of Celgene Corporation, has announced the release of additional data on exploratory endpoints from its Phase 2 clinical trial assessing ozanimod in people with moderate to severe ulcerative colitis (UC). The data, showing improvements in histologic measures and remission, was presented at the recent 11th Congress of the European Crohn’s and Colitis Organization (ECCO) in Amsterdam.
Ozanimod is a small molecule sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in development for immune-inflammatory indications. Treatment with S1P receptor modulators is designed to work by interfering with S1P signaling and blocking the response of lymphocytes to exit signals from the lymph nodes. This process results in a reduction of circulating lymphocytes and anti-inflammation activity, by inhibiting the migration of pathologic lymphocytes to inflammation sites.
Results presented at ECCO indicated that ozanimod 1mg treatment led to histologic improvement and remission in patients over 32 weeks. “It’s exciting to observe histologic improvements in patients with ulcerative colitis who were treated with ozanimod. Clinical research suggests that histologic improvements can be linked with improved clinical outcomes in ulcerative colitis,” Dr. William Sandborn, a professor of medicine at University of California San Diego, said in a press release. “While often more difficult to measure, endpoints such as histologic improvement or remission are emerging as important treatment goals for patients and their physicians.”
The Phase 2 TOUCHSTONE trial is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ozanimod (RPC1063) versus placebo in 197 people with moderate to severe UC. Participants were given 1 mg ozanimod (n=67), 0.5 mg ozanimod (n=65), or placebo (n=65) once daily for eight weeks in an introduction phase, and those showing clinical response at week eight continued their assigned treatment through week 32 (maintenance phase).
The trial’s primary endpoint was the proportion of patients in remission at week eight, and secondary endpoints were the proportion of patients achieving clinical response, the proportion achieving mucosal improvement, and changes from baseline in the Mayo score. Histologic improvement and remission were assessed as exploratory endpoints.
Data previously released showed both the primary and secondary endpoints were met with statistical significance for patients on 1mg of ozanimod compared to placebo.
Histologic improvement results presented at ECCO, assessing the change from baseline in Geboes score, also showed improvement was significantly greater in the 1 mg dose group compared to placebo at both week eight (-4.37 versus -2.20, p=0.0345) and week 32 (-5.50 versus -2.24, p=0.0033). (In Geboes, a decrease in absolute score signals improvement.) The 0.5 mg group showed improvement compared to placebo, but changes were not significant at either week eight or 32.
Histologic remission at week 32 was reported in 31 percent (21 people) of patients on ozanimod 1 mg compared with 8 percent (5) on placebo, and 23 percent (15) on a 0.5 mg dose versus placebo.
Adverse events were found in 38.8 percent of patients in the 1mg arm (26 people); 40.0 percent of patients in the 0.5 mg arm (26); and 40.0 percent of those in the placebo arm (26). The most common were disease worsening (in 3, 2, and 5 patients, respectively) and anemia (0, 3, and 4 patients, respectively).
“These data suggest that in addition to benefits we’ve previously seen, oral ozanimod could also help ulcerative colitis patients achieve the important treatment goal of histologic remission,” said Scott Smith, president of Celgene Inflammation & Immunology. “We are committed to bringing innovative medicines and different treatment options for patients with inflammatory bowel disease and continue to actively advance the phase 3 clinical program for ozanimod.”
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