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news.Receptos' selective sphingosine-1- phosphate receptor 1 (S1P1) modulator, RPC1063 has been administered to the first patient in a phase 2/3 study.
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RPC1063 is a S1P1 selective modulator, which shows picomolar potency that is effective in rodent models of both multiple sclerosis and inflammatory bowel disease and has safety profile in non-clinical toxicology studies.
RPC01-201, a Phase 2/3 placebo-controlled (Phase 2) and active comparator-controlled (Phase 3) trial, is the first of two planned pivotal studies for RPC1063 of relapsing multiple sclerosis (RMS).
RPC01-201 phase 2 assesses the clinical efficacy of RPC1063 in reducing the cumulative number of total gadolinium enhancing lesions by MRI from week 12 to 24 of study treatment in comparison to placebo while phase 3 compares RPC1063 to an active control in RMS patients and is a pivotal registrational study.
As part of the studies, more than 1000 patients will receive one of two doses of RPC1063 or interferon beta-1a 30 mcg weekly injection for at least two years.
The study aims to know RPC1063 superiority over IFN beta-1a in reducing the rate of relapse at 24 months in patients with RMS.
Receptos president and chief executive officer Faheem Hasnain said phase 1 data indicates that RPC1063 has favorable intrinsic safety and pharmaceutical properties creating a foundation for differentiated clinical profile.
"In addition, we are very excited to be moving into a Phase 2/3 study which also provides the opportunity to position RPC1063 as a potential next to market candidate in the S1P1 receptor modulator class of compounds," Hasnain added.