SAN DIEGO, April 28, 2014 (GLOBE NEWSWIRE) -- Receptos Inc. (Nasdaq: RCPT ) today announced that Company personnel will deliver two scientific poster presentations regarding its lead program, RPC1063, at the annual meeting of the American Academy of Neurology (AAN) in Philadelphia, PA. RPC1063 is the Company's sphingosine 1-phosphate 1 receptor (S1P1R) modulator in Phase 3 development for relapsing multiple sclerosis (RMS) and Phase 2 development for inflammatory bowel disease (IBD).
The first Receptos poster presentation is titled "Absence of a Relevant Effect on Cardiac Repolarization in a QT/QTc (TQT) Study of RPC1063, a Novel, Selective S1P1 Receptor Agonist, in Healthy Adult Volunteers." The data presented in the poster demonstrate that at steady state, therapeutic and supratherapeutic doses of RPC1063 had no effect on cardiac repolarization as measured by the effects on Fridericia corrected QT interval (QTcF), ruling out a relevant effect of RPC1063 on QT interval. The dose titration regimen employed during the study appeared to attenuate first dose heart rate effects and RPC1063 was well tolerated throughout the titration period. No notable safety issues were identified.
The second Receptos poster presentation is titled "Pharmacokinetics and Pharmacodynamics of RPC1063 and its Biologically Active Metabolites in Healthy Adult Volunteers." The poster presents an evaluation of the clinical pharmacokinetics (PK) and pharmacodynamics (PD) of RPC1063 and its two active metabolites, which share the potency and selectivity of RPC1063 towards S1P1R. As measured in two Phase 1 Studies, the PK of the metabolites was similar to that of RPC1063 with elimination half-lives of 19-22 hours and low inter-subject variability. The extent of lymphocyte reduction at steady state correlated well with the parent and total agonist exposures. Like RPC1063, the metabolites have favorable safety characteristics, leading to the conclusion that RPC1063 and its two pharmacologically active metabolites have a favorable overall profile for the potential treatment of autoimmune disease.
"We continue to characterize the profile of RPC1063 through clinical and preclinical experiments," said Faheem Hasnain, President and Chief Executive Officer of Receptos. "These data demonstrate favorable characteristics for RPC1063, including, importantly, the lack of effect on QT interval and the modest impact on heart rate which appear to demonstrate a differentiated cardiac safety profile."
Tuesday, April 29 at 7:30 AM: Poster Session II: MS and CNS Inflammatory Disease: Treatment Safety Poster 229: "Absence of a Relevant Effect on Cardiac Repolarization in a QT/QTc (TQT) Study of RPC1063, a Novel, Selective S1P1 Receptor Agonist, in Healthy Adult Volunteers"
Monday, April 28 at 3:00 PM: Poster Session I: MS and CNS Inflammatory Disease: Treatment Mechanisms of Action Poster 211: "Pharmacokinetics and Pharmacodynamics of RPC1063 and its Biologically Active Metabolites in Healthy Adult Volunteers"
About RPC1063 and S1P1R Modulators
RPC1063 is a novel, oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator in development for autoimmune indications. Receptos is currently investigating RPC1063 in a Phase 2/3 study in RMS called RADIANCE. The Phase 2 portion of RADIANCE is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against placebo in patients with RMS. Enrollment in the Phase 2 portion was completed in October 2013 with a total of 258 patients. In December 2013, based on an interim analysis of the Phase 2 portion of RADIANCE, Receptos initiated enrollment in the Phase 3 portion of the program. The Phase 3 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.
About Receptos
Receptos is a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases. The Company's lead program, RPC1063, is an S1P1R small molecule modulator candidate for immune indications, including RMS and 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).
Forward-Looking Statements
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," "believes," "may," "intends," "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 the safety, efficacy and projected development timeline of drug candidates such as RPC1063 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 discussed above 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 are described in detail in the Company's SEC filings, including the Company's Annual Report on Form 10-K. 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.
Media and Investor Contacts: Graham K. Cooper Chief Financial Officer, Receptos (858) 652-5708 Michael Rice LifeSci Advisors, LLC (646) 597-6979
