Receptos, Inc., announced today that their highly selective sphingosine-1-phosphate receptor 1 (S1P1) agonist, RPC1063, has been administered to the first subject in a single-ascending and multiple-ascending dose design Phase 1 clinical safety study. The study is being conducted in healthy male and female volunteers at a single site in the United States under an Investigational New Drug (IND) application recently allowed by the FDA. Receptos is developing RPC1063 as a potential treatment for multiple sclerosis.
The study will generate data to confirm that the characteristics of RPC1063 meet pre-specified pharmacokinetic (PK), pharmacodynamic (PD), and safety criteria. These include half-life determination to support once-per-day dosing, and measures that will focus on extent and speed of reversibility of lymphopenia. Safety features will also include observation of cardiovascular, hepatic, lung, and ocular events. The goal of the Phase 1 study will be to utilize the PK-PD relationship of RPC1063 to accurately select dose levels for Phase 2 evaluation.
"The progression of RPC1063 into Phase 1 development marks the evolution of Receptos into a clinical stage organization. The exceptional performance of the development team at Receptos has been demonstrated by their ability to initiate clinical trials for our lead compound within 14 months of our Series A funding round," said Faheem Hasnain, President and Chief Executive Officer of Receptos. "Clearly our forward focus in the RPC1063 clinical program will be to provide meaningful product candidate differentiation to serve the multiple sclerosis market with this potentially best-in-class S1P1 agonist."
The Phase 1 study is anticipated to conclude in 2011, paving the way for a Phase 2 Proof of Concept (PoC) study in 2012. In addition, RPC1063 may be investigated in other immune-mediated disorders. The Receptos portfolio of proprietary S1P1 agonist compounds also contains candidates that exhibit diverse molecular and therapeutic profiles that may be used to fully exploit the therapeutic potential of the class.
Foundation receives $100,000 to advance MS care