Receptos Initiates SUNBEAM Phase 3 Trial of RPC1063 in Relapsing Multiple Sclerosis
December 22 2014 - 7:00AM
– Following Positive Phase 2 Results,
Receptos Now Enrolling Two Phase 3 Trials in Relapsing Multiple
Sclerosis –
– Receptos Well Capitalized to
Advance Clinical Development Program –
Receptos, Inc. (Nasdaq:RCPT) announced today that the Company has
enrolled the first patient in the SUNBEAM Phase 3 trial of RPC1063
in patients with relapsing multiple sclerosis (RMS). The
Company had previously initiated the Phase 3 portion of the
RADIANCE trial in patients with RMS. With both trials now
actively enrolling patients, Receptos is on track to complete this
Phase 3 clinical development program in 2017.
"Our initiation of the SUNBEAM trial represents another major
corporate milestone for Receptos, and positions RPC1063 as the
potential next-to-market oral agent for the treatment of relapsing
multiple sclerosis," said Faheem Hasnain, President and Chief
Executive Officer of Receptos. "Following our recent positive
Phase 2 results in ulcerative colitis, we also plan to initiate a
Phase 3 program for RPC1063 in inflammatory bowel disease in
2015. We believe that this drug candidate represents a
potential franchise in immunology, and we continue to explore
opportunities in other therapeutic indications where there is
strong scientific rationale."
The announcement follows the disclosure in September 2014 of the
detailed Phase 2 results of RPC1063 in RMS. In that
trial, RPC1063 met the primary endpoint of reduction in MRI brain
lesion activity as well as secondary endpoints measuring effects on
other MRI parameters. The overall safety profile of RPC1063
was consistent with the results of prior trials and continues to be
differentiated on this basis from other oral agents for treatment
of RMS.
As with the RADIANCE trial, the SUNBEAM 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. The primary objective for the RADIANCE and SUNBEAM trials
is to assess whether RPC1063 is superior to Avonex® in
reducing the annualized relapse rate in patients after two years of
therapy and one year of therapy, respectively. Both Phase 3
trials are being conducted under Special Protocol Assessment (SPA)
agreement with the FDA.
In November 2014, Receptos completed an underwritten public
offering of common stock raising $414 million in gross
proceeds. This adds to the Company's significant balance of
cash, cash equivalents and short-term investments, which
totaled $302.9 million as of September 30, 2014.
About RPC1063
RPC1063 is a novel, oral, once daily, selective sphingosine
1-phosphate 1 and 5 receptor modulator in development for
autoimmune indications including relapsing multiple sclerosis (RMS)
and ulcerative colitis (UC). In a Phase 2 trial in patients
with RMS, RPC1063 achieved the primary endpoint of reduction in MRI
brain lesion activity as well as secondary endpoints measuring
effects on other MRI parameters. The overall safety profile of
RPC1063 was consistent with the results of prior trials and
continues to demonstrate differentiation against other oral agents
for treatment of RMS. Receptos is now conducting a Phase 3
clinical development program comprised of two trials: RADIANCE
and SUNBEAM, both of which are randomized, double-blind studies
designed to compare 0.5 mg and 1.0 mg of RPC1063 against interferon
beta-1a (Avonex®) in patients with RMS.
RPC1063 is also being studied in inflammatory bowel disease
(IBD). The TOUCHSTONE Phase 2 trial of RPC1063 in UC met its
primary endpoint and all secondary endpoints with statistical
significance in patients on the 1 mg dose of RPC1063 in the 8-week
induction period. The overall safety and tolerability profile
of RPC1063 was consistent with the results of the recent Phase 2
trial in RMS, and continues to support the potential for orally
administered RPC1063 to significantly improve the treatment
paradigm for UC patients. The maintenance period of the TOUCHSTONE
trial is currently ongoing. Receptos plans to initiate a Phase
3 program in UC and a Phase 2 program in Crohn's disease in
2015.
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 and 5 receptor small molecule modulator in
development for immune indications including RMS and IBD.
Patents supporting RPC1063 were exclusively licensed to
Receptos from The Scripps Research
Institute (TSRI). The Company is also developing RPC4046,
an anti-interleukin-13 (IL-13) antibody for eosinophilic
esophagitis (EoE), an allergic/immune-mediated orphan disease.
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. Investors
are cautioned that these forward-looking statements are not
guarantees of future performance. Forward-looking
statements, include without limitation, statements regarding the
sufficiency of the Company's capital to fund its future operations,
the ability of the Company to successfully undertake certain
development activities (such as clinical trial enrollment and the
conduct of clinical trials) and accomplish certain development
goals (such as the completion of clinical trials and availability
of clinical trial results), and the safety, efficacy, projected
development timeline and therapeutic and commercial potential for
RPC1063, RPC 4046 and the GLP-1 positive allosteric modulator
program. 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 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 Annual Report on Form 10-K for the year
ended December 31, 2013 and subsequent 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
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