Receptos Provides Update on Progress of Lead Product Candidate RPC1063
June 05 2013 - 8:00AM
- Successfully Completes Thorough QT Study
- Obtains Special Protocol Assessments (SPAs) From FDA
for Phase 3 Trials in Relapsing Multiple Sclerosis
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company
developing therapeutic candidates for the treatment of immune and
metabolic diseases, confirmed today that RPC1063, its selective
sphingosine‐1‐ phosphate 1 receptor (S1P1R) modulator, has
successfully completed a study of the heart's electrical conduction
system, known as a "thorough QT/QTc" (TQT) study. RPC1063 is
currently being studied in randomized Phase 2 trials for the
treatment of relapsing multiple sclerosis (RMS) and ulcerative
colitis (UC).
The purpose of a TQT study is to rule out the potential for a
drug to cause prolongation of the mean corrected QT interval (known
as the QTc interval). Prolongation of the QTc interval increases
the risk of ventricular arrhythmia, which can lead to palpitations,
fainting and sudden death. Drugs that cause QTc prolongation are
often contraindicated in certain "at risk" patients or in patients
taking select concomitant medications that also cause QTc
prolongation.
The completed RPC1063 TQT study enrolled 124 subjects, with 62
subjects randomized to receive RPC1063 at an intended therapeutic
dose (1 mg/day) and at a supra-therapeutic dose (2 mg/day), and 62
subjects randomized to receive placebo. The dosage of RPC1063 was
titrated in this study from 0.25 mg to 2.0 mg over 14 days of
treatment. The primary objective of the TQT study was to assess
whether exposure to therapeutic and supra-therapeutic doses of
RPC1063 in healthy subjects increased the QTc interval compared to
placebo. As previously disclosed, the primary objective of the TQT
study was met. Specifically, the study was "negative" in that a
relevant QTc effect was ruled out for RPC1063 at both the
therapeutic and the supra-therapeutic doses. In addition, the TQT
study was validated by reproducing the known effect of a positive
control treatment (moxifloxacin) on the QTc interval as part of the
study. This study nearly doubled the subject exposure to RPC1063,
building on the results of a prior Phase I trial in 88 healthy
subjects that demonstrated target reductions in lymphocyte counts
as well as a desirable safety and tolerability profile.
The TQT study included additional assessments in order to
establish further evidence for a potentially improved cardiac
safety profile for RPC1063. In particular, heart rate changes were
measured using the dose titration regimen, which is being employed
in all ongoing and planned RPC1063 studies. Detailed heart rate
data was collected through continuous 24-hour ambulatory ECG
monitoring pre-dose and throughout the dose escalation period to
assess changes in heart rate and the risk of any cardiac adverse
events. The dose titration regimen appeared to attenuate the first
dose heart rate effects and was well tolerated. No serious adverse
events occurred during the TQT study and a similar proportion of
subjects experienced mild or moderate adverse events in both the
placebo and RPC1063-treated groups.
Separately, the Company confirmed as previously disclosed that
it has obtained two Special Protocol Assessment (SPA) agreements
from the FDA for the planned Phase 3 portion of the RPC1063 Phase
2/3 RADIANCE study as well as a second planned Phase 3 study of
RPC1063 in RMS. SPA agreements are put in place to document
concurrence between the FDA and the study sponsor on both trial
design and statistical analysis plans for Phase 3 registration
studies to support regulatory approval.
"We are encouraged by the results of the TQT study, which
contribute to our understanding of the emerging favorable safety
and tolerability profile of RPC1063," said Sheila Gujrathi, M.D.,
Chief Medical Officer of Receptos. "In addition, the two SPA
agreements for the Phase 3 registration program position RPC1063 as
a potential next-to-market S1P1R modulator in RMS. We believe we
are building a compelling body of evidence to support a
multi-faceted differentiation profile for RPC1063, including a
potentially improved cardiovascular profile which may result in
safety advantages for patients."
About RPC1063 and S1P1R Modulators
RPC1063 is a novel, oral, once daily, selective and potent 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. Receptos is
currently enrolling patients into the randomized Phase 2 portion of
a Phase 2/3 study called RADIANCE examining the efficacy, safety
and tolerability of RPC1063 in RMS and a randomized Phase 2 study
called TOUCHSTONE examining the efficacy, safety and tolerability
of RPC1063 in 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 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 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 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
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