RPC1063: Phase II data

Additional data from 258 patients with relapsing MS in the Phase II portion of the double-blind, international Phase II/III RADIANCE trial showed that once-daily oral RPC1063 reduced the number of gadolinium-enhancing lesions at week 24, a secondary endpoint, by 91% at the 0.5 mg dose and by 94% at the 1 mg dose vs. placebo (p<0.0001 for both). RPC1063 also reduced the cumulative number of new/enlarging T2 lesions from week 12 to week 24, also a secondary endpoint, by 84% at the 0.5 mg dose and by 91% at the 1 mg dose vs. placebo (p<0.0001 for both). Additionally, RPC1063 reduced ARR by 31% (p=0.27) at the 0.5 mg dose and by 53% (p=0.053) at the 1 mg dose vs. placebo. The Phase II portion was not powered to detect a significant difference between treatment groups in ARR. The data were reported in an abstract released ahead of a presentation to be made at the Joint ACTRIMS-ECTRIMS meeting in Boston on Sept. 13.

In June, Receptos reported top-line data from the Phase II portion showing that both doses of RPC1063 met the primary endpoint of reducing the cumulative number of total gadolinium-enhancing lesions as determined by MRI from week 12 to week 24 vs. placebo. Specifically, both doses of RPC1063 reduced the cumulative number of total gadolinium-enhancing lesions by 86% vs. placebo (p<0.0001 for both). Both doses of RPC1063 also met secondary endpoints measuring effects on other MRI parameters, including measures of gadolinium-enhancing lesion count at week 24 and effects on T2 lesions, vs. placebo (p<0.0001 for both) (see BioCentury, June 16). ...