Receptos to Initiate Phase 3 Trial of RPC1063 in Relapsing Multiple Sclerosis
06 December 2013 - 12:00AM
– Data from Interim Analysis of Phase 2 Trial
Provide Support to Advance Program – – Interim
Data Consistent with RPC1063 Differentiation Profile –
SAN DIEGO, Dec. 5, 2013 (GLOBE NEWSWIRE) -- Receptos, Inc.
(Nasdaq:RCPT) announced today that the Company has completed a
pre-planned interim analysis of the Phase 2 portion of RADIANCE,
its Phase 2/3 trial of RPC1063 in relapsing multiple sclerosis
(RMS). The Data Monitoring Committee (DMC) reviewed data from
the interim analysis of the study and approved continuation of the
Phase 2 portion as well as initiation of the Phase 3 portion of the
study. The results continue to support the RPC1063
differentiation profile and are consistent with data from prior
RPC1063 studies. Based on the results of the interim analysis
and the DMC recommendation, Receptos will initiate the Phase 3
portion of RADIANCE. Top-line results of the Phase 2 portion
of the study continue to be expected in mid-2014.
The interim analysis focused on several potential product
attributes that may be important for differentiation from other S1P
receptor modulators on the market or in development. The
following preliminary observations of the interim data were made
with regard to key aspects of the product profile:
- The overall adverse event profile appears relatively balanced
between RPC1063 and placebo groups, with no serious adverse events
observed to date;
- Modest impact on heart rate for RPC1063-treated patients
compared to placebo patients, consistent with results of the
earlier RPC1063 thorough QT study, with no cardiac adverse events
observed to date;
- Low rates of liver enzyme elevations observed in study to date
that appear supportive of a favorable hepatotoxicity profile;
- Preliminary clinical activity and reduction in lymphocyte count
that appear to be consistent with data from other S1P receptor
modulators on the market or in development.
"We are pleased with the results of this interim analysis, which
we believe further de-risk the program," said Faheem Hasnain,
President and Chief Executive Officer of Receptos. "These results
support initiation of the Phase 3 portion of RADIANCE, a major
milestone in our development program for RPC1063. We continue
to look forward to the top-line results for this Phase 2 RMS trial
in mid-2014, as well as the results of our Phase 2 trial in
ulcerative colitis."
About RPC1063
RPC1063 is a novel, oral, once daily, selective and potent
sphingosine 1-phosphate 1 receptor (S1P1R) modulator in development
for autoimmune indications. Previously reported Phase 1 results
demonstrated adequate pharmacokinetic, pharmacodynamic and safety
features, which provide supportive data for the differentiation
strategy for RPC1063 as a potential best-in-class second generation
S1P1R modulator. The Phase 2 portion of the RADIANCE trial is
a randomized, double-blind study designed to compare 0.5 mg and 1.0
mg of RPC1063 against placebo in 210 patients with
RMS. Enrollment was completed in October 2013, with the number
of patients enrolled in the study exceeding the number
planned. The Phase 3 portion of the trial will be a
randomized, double-blind study designed to compare 0.5 mg and 1.0
mg of RPC against interferon beta-1a 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," "believes," "anticipates," "may,"
"intends," "plans," "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 discussed above and final trial results, 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 and the Registration
Statement on Form S-1 which was declared effective on May 8,
2013. 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
RECEPTOS, INC. (NASDAQ:RCPT)
Historical Stock Chart
From Jun 2024 to Jul 2024
RECEPTOS, INC. (NASDAQ:RCPT)
Historical Stock Chart
From Jul 2023 to Jul 2024