Receptos Begins Enrollment of Phase 3 Trial of RPC1063 in Relapsing Multiple Sclerosis
07 January 2014 - 8:05AM
– Pivotal Phase 3 Trial is Underway with
First Patients Randomized in December 2013 –
– Topline Results of Phase 2 Still
Expected in Mid-2014 –
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."
About RPC1063
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.
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 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).
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," "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
gcooper@receptos.com
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
mrice@lifesciadvisors.com
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