Receptos Reports Positive Results for the Maintenance Period of the Phase 2 TOUCHSTONE Trial of Ozanimod in Ulcerative Coliti...
16 April 2015 - 10:00PM
- Study met all efficacy endpoints with
statistical significance for patients on 1 mg dose after 32 weeks
of treatment -
- Safety data are consistent with the favorable
profile observed in prior clinical trials -
- Receptos plans to accelerate initiation of
Phase 3 program in ulcerative colitis and Phase 2 program in
Crohn's disease -
Receptos, Inc. (Nasdaq:RCPT) today announced that the maintenance
period of TOUCHSTONE, the Phase 2 trial of ozanimod (formerly
RPC1063) in ulcerative colitis (UC), met all efficacy endpoints
with statistical significance in patients on the 1 mg dose of
ozanimod after 32 weeks of treatment. The overall safety and
tolerability profile of ozanimod was consistent with the results of
TOUCHSTONE's induction period and those observed in the RADIANCE
Phase 2 trial in relapsing multiple sclerosis (RMS), and continues
to support the potential for orally administered ozanimod to
significantly improve the treatment paradigm for UC patients.
This randomized, double-blind, placebo-controlled trial assessed
the efficacy, safety and tolerability of two orally administered
doses (0.5 mg and 1 mg) of ozanimod versus placebo in 199 patients
with moderately-to-severely active UC across 57 sites in 13
countries. For the induction period, the trial met its primary
efficacy and all secondary endpoints with statistical significance
for patients on the 1 mg dose after 8 weeks of treatment. In the
maintenance portion of the trial, 103 patients who had achieved
clinical response at week 8 continued with treatment for an
additional 24 weeks. The proportion of patients in clinical
remission at week 32 as defined by the industry standard Mayo
scoring criteria was statistically significant in favor of both the
1 mg group and the 0.5 mg group (p < 0.05) compared to
placebo.
All secondary endpoints at week 32, including clinical response,
change in the Mayo score and mucosal improvement on endoscopy were
also positive and statistically significant for the 1 mg
dose. The detailed results of the maintenance period portion
of the TOUCHSTONE trial are expected to be presented at a major
scientific meeting in the coming months.
Ozanimod was generally well tolerated, and the incidence of
adverse events across the active treatment groups and placebo
appeared to be similar. Most adverse events were either mild
or moderate in nature, and there appeared to be no concerning
signals in the adverse events of special interest, including the
cardiac and hepatic safety profiles. Rates of liver
transaminase elevations observed in patients receiving ozanimod
were low and consistent with the earlier Phase 2 trial in RMS.
"The robust results observed in the maintenance portion of this
trial support the longer term efficacy of ozanimod," said Dr.
William Sandborn, M.D., Professor of Medicine and Chief, Division
of Gastroenterology and Director, University of California San
Diego Inflammatory Bowel Disease Center. "Ozanimod appears to
show effectiveness in both inducing and maintaining clinical
remission and response in patients with ulcerative colitis, with a
favorable overall safety profile."
Receptos plans to initiate a Phase 3 program in 2015 in patients
with moderately-to-severely active UC to confirm these
findings. In addition, these results continue to suggest the
potential for ozanimod to be used in the treatment of Crohn's
disease, a related inflammatory bowel disease. Receptos plans to
initiate a Phase 2 study of ozanimod for the treatment of Crohn's
disease in 2015.
"The positive results of the maintenance period of the
TOUCHSTONE study exceeded our expectations with respect to the
potential for long term clinical benefit of ozanimod in ulcerative
colitis," said Faheem Hasnain, President and Chief Executive
Officer of Receptos. "The consistency of the efficacy data across
the various endpoints for the high dose, combined with the
favorable safety profile, gives us continued confidence to advance
the development of ozanimod in inflammatory bowel
disease. Having completed our end-of-phase 2 meeting with the
FDA and Scientific Advice meetings with the Competent Authorities
in Europe, we believe that we now have regulatory alignment and are
prepared to accelerate the initiation of the Phase 3 program in
ulcerative colitis."
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
immunology 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.
About Ozanimod
Ozanimod (formerly RPC1063) is a novel, oral, once daily,
selective sphingosine 1-phosphate 1 and 5 receptor modulator in
development for immunology 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 both the
8-week induction and the 32-week maintenance periods. The
overall safety and tolerability profile of ozanimod was consistent
with the results of the RADIANCE Phase 2 trial in RMS, and
continues to support the potential for orally administered ozanimod
to significantly improve the treatment paradigm for UC patients.
Receptos plans to initiate a Phase 3 program in UC and a Phase 2
program in Crohn's disease in 2015.
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, 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. 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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