Receptos, Inc. announced today that the Company has enrolled the first patients in the Phase 3 portion of RADIANCE, its Phase 2/3 study of RPC1063 in relapsing multiple sclerosis (RMS). The announcement follows the review of interim analysis of the Phase 2 portion of the study which was announced in December 2013.
The RADIANCE Phase 2/3 study was designed to accelerate the RMS clinical development program for RPC1063 by allowing advancement into Phase 3 in a rapid fashion and eliminating the delay that typically exists between the completion of a Phase 2 study and the initiation of a subsequent Phase 3 study. Many of the clinical trial sites involved in the Phase 2 portion of the study are also participating in the Phase 3 portion of the study, allowing for efficient enrollment of Phase 3 patients that are separate from the Phase 2 patient population. In addition, Receptos has obtained Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration on the clinical trial design for both the Phase 3 portion of RADIANCE as well as a second planned RMS Phase 3 study. The second Phase 3 study is planned to begin after announcement of the top-line results of the Phase 2 portion of the RADIANCE study, which is expected to occur in mid-2014.
"Our initiation of Phase 3 positions RPC1063 as the potential next-to-market sphingosine 1-phosphate 1 receptor (S1P1R) modulator for the treatment of relapsing multiple sclerosis," said Faheem Hasnain, President and Chief Executive Officer of Receptos. "Since the founding of Receptos in 2009, we have made rapid progress in the development of RPC1063, which we believe may represent a best-in-class molecule in the S1P1R modulator class. In addition to the top-line results of the Phase 2 portion of RADIANCE, we also look forward in mid-2014 to the top-line results of TOUCHSTONE, our Phase 2 study of RPC1063 in ulcerative colitis, as well as continued progress with our pipeline programs."
RPC1063 is a novel, oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator in development for autoimmune indications. The Phase 2 portion of the RADIANCE study is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against placebo in patients with RMS. While the Phase 2 study was originally designed to enroll 210 patients, the trial over enrolled a total of 258 patients and completed enrollment on time in October 2013. The Phase 3 portion of the trial is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against interferon beta-1a (Avonex(R)) in 1,200 patients with RMS. Receptos is also enrolling a randomized Phase 2 study, called TOUCHSTONE, examining the efficacy, safety and tolerability of RPC1063 in ulcerative colitis (UC). Top-line results for both studies are expected in mid-2014.
Source: MarketWatch Copyright © 2014 MarketWatch, Inc (07/01/14)
Receptos, Inc. said its oral, once daily, selective and potent S1P1R modulator RPC1063 completed a thorough QT/QTc or TQT study of heart's electrical conduction system and met its primary objective. The company also obtained special protocol assessments or SPA from FDA for Phase 3 Trials in Relapsing Multiple Sclerosis.
RPC1063 is currently in development for autoimmune indications and being studied in randomized Phase 2 trials for the treatment of relapsing multiple sclerosis and ulcerative colitis.
The company noted that the TQT study was to rule out the potential for a drug to cause prolongation of the mean corrected QT interval that increases the risk of ventricular arrhythmia, which can lead to palpitations, fainting and sudden death.
According to Receptos, the TQT study enrolled 124 subjects, with 62 subjects randomized to receive RPC1063 at an intended therapeutic dose of 1 mg/day and at a supra-therapeutic dose of 2 mg/day, and 62 subjects randomized to receive placebo.
Source: Copyright © 2013 RTTNews (10/06/13)
Receptos, Inc., announced today that its selective sphingosine 1-phosphate receptor 1 (S1P1) modulator, RPC1063, has been administered to the first patient in a Phase 2/3 study. 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 in the indication of relapsing multiple sclerosis (RMS).
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
RPC1063 is a novel, differentiated sphingosine 1-phosphate 1 receptor (S1P1) selective modulator exhibiting picomolar potency that is effective in rodent models of both multiple sclerosis (MS) and inflammatory bowel disease (IBD), and possesses an excellent safety profile in non-clinical toxicology studies. Receptos has completed a Phase 1 clinical safety study with RPC1063 under a US IND that supports the desired differentiation profile and establishes justification for initiation of MS and IBD clinical efficacy trials in 2012. S1P1 is a G protein-coupled receptor (GPCR) that binds the lipid signaling molecule sphingosine 1-phosphate (S1P). S1P is a circulating lipid that binds to five GPCRs termed S1P1-5. S1P1 selectively regulates physiological functions in the immune and cardiovascular systems, including immune cell trafficking and the maintenance of endothelial integrity. In autoimmune disorders, S1P1 agonism works by selectively sequestering circulating lymphocytes, blunting the underlying cause of disease.
Source: Therapeutics Daily © 2012 UBM Canon (23/10/12)