Prurisol indeed could be the Real Big Mover... very much looking fwd to seeing how we do in the 300mg and 400mg arms. Hoping for that at least as good as, if not better (maybe doubling) Otezla.
Back to IBD as we await Topline results. Like Xelganz, Ozanimod hasn't posted the most stellar Remission results (below), and they only used Mucosal healing as an exploratory measure.
These drugs in later-stage testing both would be the best comps for Brilacidin if/when orally formulated and tested in larger, powered trials.
The Mayo Clinic score was used to measure disease activity on a scale from 0 to 12, with higher scores indicating more severe disease; subscores range from 0 to 3, with higher scores indicating more severe disease. The primary outcome was clinical remission (Mayo Clinic score ≤2, with no subscore >1) at 8 weeks.
Results
Efficacy Primary Outcome
At week 8, clinical remission occurred in 11 of 67 patients (16%) who received 1 mg of ozanimod and in 9 of 65 patients (14%) who received 0.5 mg of ozanimod, as compared with 4 of 65 (6%) who received placebo
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Exploratory Outcomes Given the nonsignificant findings for the comparison of the remission rate at week 8 in the group that received 0.5 mg of ozanimod with that in the placebo group, all subsequent analyses were considered to be exploratory and the results not significant (nominal P values are provided). Clinical response at week 8 occurred in 24 of 65 patients (37%) in the placebo group, as compared with 35 of 65 (54%) who received 0.5 mg of ozanimod (P=0.06) and 38 of 67 (57%) who received 1 mg of ozanimod (P=0.02) (Figure 1B). Mucosal healing at week 8 occurred in 8 of 65 patients (12%) in the placebo group, as compared with 18 of 65 (28%) in the group that received 0.5 mg of ozanimod (P=0.03) and 23 of 67 (34%) in the group that received 1 mg of ozanimod (P=0.002) (Figure 1C).
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