Receptos Reports Positive Phase 2 Results for RPC1063 in Relapsing Multiple Sclerosis
June 09 2014 - 4:05PM
– Study met primary efficacy endpoint with
statistical significance after 24 weeks of treatment –
– Safety data are supportive of differentiated
product profile –
– Investor conference call and
webcast today at 5:00 p.m. EDT (2:00 p.m. PDT) –
Receptos, Inc. (Nasdaq:RCPT) today announced that the Phase 2
portion of the RADIANCE trial of its selective S1P1 receptor
modulator, RPC1063, in relapsing multiple sclerosis (RMS) met the
primary endpoint, reduction in MRI brain lesion activity. The
overall safety profile of RPC1063 was consistent with the results
of prior trials, and continues to support the differentiation of
the drug candidate against other oral agents for treatment of RMS
on the market or in clinical development.
The randomized, double-blind study assessed the efficacy, safety
and tolerability of two orally administered doses (0.5 mg and 1.0
mg) of RPC1063 against placebo in 258 patients with RMS across 77
sites in 13 countries. The primary endpoint of the
trial was the reduction in the cumulative number of total
gadolinium-enhancing (GdE) lesions determined by MRI from week 12
to week 24 of study treatment, a standard endpoint for Phase 2
trials in this indication. Patients on RPC1063 experienced a
statistically significant reduction in GdE lesions of 86% at both
0.5 mg and 1.0 mg compared to patients on placebo (p-values
<0.0001 for each dose group compared to placebo). Secondary
endpoints measuring effects on other MRI parameters were also
positive and statistically significant (p<0.0001 for each dose
group compared to placebo). Although this Phase 2 portion of
the trial was not powered to detect a statistically significant
difference between RPC1063 treatment arms and placebo on annualized
relapse rate (ARR), there was a favorable trend for both RPC1063
dose groups. The detailed results of the Phase 2 portion of
the RADIANCE trial are expected to be presented at a major
scientific meeting in coming months.
Safety and tolerability data from the trial provide support for
a differentiated, potential best-in-class profile. The overall
adverse event profile appeared relatively similar between the
RPC1063 dose groups and placebo with no concerning safety signals
for patients receiving RPC1063. First dose changes in heart
rate in patients receiving RPC1063 were generally modest (maximum
mean reduction <2 beats per minute compared to baseline)
with no patients dropping below 45 beats per minute during the
first six hours after administration, which is consistent with the
findings of the Company's earlier thorough QT study.
Rates of liver transaminase elevations observed in patients
receiving RPC1063 were low relative to agents with similar
mechanisms of action on the market or in clinical development, and
supportive of a favorable hepatic safety profile.
"The results of this trial demonstrated a significant treatment
effect of RPC1063 at both doses, consistent with other molecules in
the class," said Jeffrey Cohen, M.D., Principal Investigator of the
RADIANCE trial and director of the Cleveland Clinic's Mellen Center
for Multiple Sclerosis Treatment and Research. "The results
also showed a favorable overall safety profile, particularly in the
critical areas of cardiovascular and hepatic side effects. The
ongoing Phase 3 trial has been designed to confirm and extend these
results."
Receptos initiated the Phase 3 portion of the RADIANCE trial
under a Special Protocol Assessment (SPA) with the FDA in December
2013. The Phase 3 portion of the trial, which is currently
enrolling patients, 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.
"The positive results of the Phase 2 portion of RADIANCE
exceeded our expectations with respect to the differentiation
thesis for RPC1063," said Faheem Hasnain, President and Chief
Executive Officer of Receptos. "Based on our analysis of the
Phase 2 dataset, we believe that RPC1063 has the opportunity to be
the best-in-class S1P receptor modulator. Our Phase 3 program
is now well underway, positioning the program as the most advanced
S1P receptor modulator in development for relapsing multiple
sclerosis. In addition, we believe that RPC1063 may have
promise in other therapeutic areas, and we continue to look forward
to the results of TOUCHSTONE, our Phase 2 trial of RPC1063 in
ulcerative colitis, in the fourth quarter of 2014."
Conference Call Today at 5:00 p.m. Eastern
Time (2:00 p.m. Pacific Time)
The Receptos management team will host a teleconference and
webcast to discuss the information in this press release. The
live call may be accessed by phone by calling (866) 757-6808
(domestic) or (760) 536-5211 (international), conference ID
58382320. The webcast can be accessed live on the Investor
Relations section of the Receptos website at www.receptos.com and
will be archived for 14 days following the call. A replay of the
call will be available by phone by calling (855) 859-2056,
participant code 58382320.
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," "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. 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
trial results to date with further 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 for the year ended December 31, 2013 and the Company's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2014.
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 Contact:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@Receptos.com
Andrew McDonald
LifeSci Advisors, LLC
(646) 597-6987
andrew@lifesciadvisors.com
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