Receptos Completes Enrollment of RADIANCE Phase 3 Trial of Ozanimod in Relapsing Multiple Sclerosis
01 Aprile 2015 - 2:00PM
SUNBEAM Phase 3 Trial of Ozanimod in Relapsing
Multiple Sclerosis Continues to Enroll According to Plan; Overall
Phase 3 Program on Track to be Completed in 1H 2017
Receptos Well Capitalized to Advance Clinical
Development Programs
Receptos, Inc. (Nasdaq:RCPT) announced today that the Company has
completed enrollment in the RADIANCE Phase 3 trial of ozanimod
(formerly RPC1063) in patients with Relapsing Multiple Sclerosis
(RMS). The trial was over-enrolled by approximately 10% due to
strong interest among investigators and patients. The Company is
continuing to enroll the SUNBEAM trial of ozanimod in patients with
RMS. Receptos is on track to complete this Phase 3 clinical
development program in the first half of 2017.
"Completing enrollment of the RADIANCE trial represents another
major corporate milestone for Receptos, and positions ozanimod 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 positive Phase 2
results in ulcerative colitis, we also plan to initiate a Phase 3
program for ozanimod in inflammatory bowel disease in 2015. We
believe that ozanimod 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 ozanimod in RMS. In that trial,
ozanimod 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 ozanimod was
consistent with the results of prior trials and continues to be
differentiated from other oral agents for the treatment of RMS.
The RADIANCE and SUNBEAM Phase 3 trials each are randomized,
double-blind studies designed to compare 0.5 mg and 1.0 mg of
ozanimod against interferon beta-1a (Avonex®) in 1,200 patients
with RMS. The primary objectives of the RADIANCE and SUNBEAM trials
are to assess whether ozanimod is superior to Avonex® in reducing
the annualized relapse rate in patients after two years of therapy
and one year of therapy, respectively. Both trials are being
conducted under Special Protocol Assessment (SPA) agreements with
the FDA.
Receptos had $671.9 million in cash, cash equivalents and short
term investments as of December 31, 2014, leaving it well
capitalized to continue advancing its clinical development
programs.
About Ozanimod
Ozanimod (formerly 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, ozanimod 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 ozanimod 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 ozanimod against
interferon beta-1a (Avonex®) in patients with RMS.
Ozanimod is also being studied in inflammatory bowel disease
(IBD). The TOUCHSTONE Phase 2 trial of ozanimod in UC met its
primary endpoint and all secondary endpoints with statistical
significance in patients on the 1.0 mg dose of ozanimod in the
8-week induction period. The overall safety and tolerability
profile of ozanimod was consistent with the results of the recent
Phase 2 trial in RMS, and continues to support the potential for
orally administered ozanimod 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, ozanimod, is a sphingosine 1-phosphate 1
and 5 receptor small molecule modulator in development for immune
indications including RMS and IBD. Patents supporting ozanimod 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 ozanimod, RPC4046 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, 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 Contacts:
Graham K. Cooper
Chief Financial Officer, Receptos
(858) 652-5708
gcooper@receptos.com
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