– Pivotal Phase 3 Trial is Underway with First Patients Randomized in December 2013 –
– Topline Results of Phase 2 Still Expected in Mid-2014 –
SAN DIEGO, Jan. 6, 2014 (GLOBE NEWSWIRE) -- 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®) 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.
Receptos is a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases. The Company's lead program, RPC1063, is a sphingosine 1-phosphate 1 receptor (S1P1R) small molecule modulator candidate for immune indications, including relapsing multiple sclerosis (RMS) and inflammatory bowel disease (IBD). The Company is also developing RPC4046, an anti-interleukin-13 (IL-13) antibody for an allergic/immune-mediated orphan disease, eosinophilic esophagitis (EoE). Receptos has established expertise in high resolution protein crystal structure determination, biology and drug discovery for G-protein-coupled receptors (GPCRs).
Statements contained in this release, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "look forward," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding development and future potential of the Company's product candidates, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation consistency of results from the interim analysis previously announced and final trial results, the Company's ability to adequately and timely recruit and enroll patients in its clinical trials, as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks regarding the Company's financial position and research and development programs are described in detail in the Company's SEC filings, including the Company's Quarterly Reports on Form 10-Q. All forward-looking statements contained in this release speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.
CONTACT: Media and Investor Contacts: Graham K. Cooper Chief Financial Officer, Receptos (858) 652-5708 firstname.lastname@example.org Michael Rice LifeSci Advisors, LLC (646) 597-6979 email@example.com