Receptos to Deliver Scientific Presentations Regarding RPC1063 at the 2014 American Academy of Neurology (AAN) Annual Meeting...
28 April 2014 - 7:00PM
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.
CONTACT: Media and Investor Contacts:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@receptos.com
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
mrice@lifesciadvisors.com
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