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Receptos doses first patient in Phase 2/3 trial for RPC1063 in MS | |
The Phase 2 portion of RPC01-201 is a randomized, double-blind comparison of two doses of RPC1063 to a placebo control in patients with RMS. The primary objective is to demonstrate the clinical efficacy of RPC1063 compared to placebo by showing a reduction in the cumulative number of total gadolinium enhancing (GdE) lesions by MRI from Week 12 to Week 24 of study treatment. The Phase 3 portion of RPC01-201 is a randomized, double-blind, double-dummy comparison of RPC1063 to an active control in patients with RMS and is a pivotal registrational study. Patients will receive one of two doses of RPC1063 or interferon (IFN) beta-1a (Avonex®) 30 mcg intramuscular weekly injection for at least two years. The primary objective will be to assess whether RPC1063 is superior to IFN beta-1a in reducing the rate of relapse at 24 months in patients with RMS. More than 1,100 patients are planned to be treated in total in the RPC01-201 study. Receptos completed a Phase 1 study with RPC1063 in the first quarter of 2012 which tested single ascending doses, multiple ascending doses and dose titration regimens in healthy volunteers. The Phase 1 results confirmed optimal pharmacokinetic, pharmacodynamic and safety features, which provide supportive data for the differentiation strategy for RPC1063 as a potential best-in-class second generation S1P1 receptor modulator. In particular, robust pharmacodynamic effects of peripheral lymphocyte count reduction were achieved in the Phase 1 study. Threshold lymphopenia levels are correlated to efficacy in the indication of MS and reaching these threshold levels enabled RPC1063 dose selection for the Phase 2/3 study. "Our Phase 1 data indicate that RPC1063 has favorable intrinsic safety and pharmaceutical properties, creating a foundation for a highly differentiated clinical profile," said Faheem Hasnain, President and Chief Executive Officer of Receptos. "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." About RPC1063 and S1P1 Modulators Source: Therapeutics Daily © 2012 UBM Canon (23/10/12) © Multiple Sclerosis Resource Centre (MSRC)
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