SAN DIEGO, Jan. 12, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation
of patient dosing in a Phase 2 clinical trial of ralinepag, an
oral, non-prostanoid prostacyclin (IP) receptor agonist intended
for the treatment of pulmonary arterial hypertension (PAH).
"An intriguing component of this compound is the smooth
peak-to-trough ratio, which may potentiate efficacy and minimize
toxicity relative to currently available therapies," said
Lewis J. Rubin, M.D., Emeritus
Professor of Medicine at University of
California, San Diego, School of Medicine. "This clinical
trial should help to further elucidate how ralinepag's intrinsic
properties translate to its efficacy and safety profile."
This 22-week, randomized, double-blind and placebo-controlled
Phase 2 trial will evaluate the hemodynamic and exercise capacity
effects, safety and tolerability of ralinepag in up to 60 patients
with PAH. During the first nine weeks of the trial, patients will
be titrated to their individual tolerance level, and then sustained
at this level for the remainder of the trial.
"We believe ralinepag offers promise in the IP receptor class of
molecules given its oral availability, long plasma half-life, and
high selectivity and potency in vitro," said Jack Lief,
Arena's President and Chief Executive Officer. "In conjunction with
our other clinical-stage programs, this compound further enhances
our optimism about Arena's value drivers."
About Pulmonary Arterial Hypertension
PAH is a progressive, life-threatening disorder characterized by
increased pressure in the arteries that carry blood from the heart
to the lungs. The increased pressure strains the heart, which can
limit physical activity, result in heart failure and reduce life
expectancy. Based on data from the Registry to EValuate Early And
Long-term PAH disease management (REVEAL) of patients in
the United States, there is an
estimated five-year survival rate of 57% from diagnosis.
About Ralinepag
Ralinepag, an orally available agonist of the IP receptor, is an
investigational drug candidate internally discovered and developed
by Arena and intended for the treatment of vascular diseases,
including PAH. In Phase 1 trials, ralinepag showed an approximate
25-hour half-life, indicating that the compound could be dosed once
or twice daily. Arena believes that an orally available,
non-prostanoid IP receptor agonist that provides clinical benefits
similar to currently available IP receptor agonists has the
potential to improve treatment for patients with PAH. The FDA has
granted ralinepag orphan drug status for the treatment of PAH.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. Arena's internally discovered drug, BELVIQ®
(lorcaserin HCl), is approved in the
United States, and Arena is focused on discovering,
developing and commercializing additional drugs to address unmet
medical needs. Arena's US operations are located in
San Diego, California, and its
operations outside of the United
States, including its commercial manufacturing facility, are
located in Zofingen, Switzerland.
For more information, visit Arena's website at
www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademark of Arena
Pharmaceuticals GmbH.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. Such
forward-looking statements include statements about the
advancement, evaluation, therapeutic indication, use, safety,
efficacy, dosing, mechanism of action, significance and potential
of ralinepag, including relative to other therapies; the protocol,
design, scope, enrollment, expectations and other aspects of the
Phase 2 clinical trial of ralinepag, including with respect to
ralinepag's properties and efficacy and safety profile; value
drivers; potential of an orally available, non-prostanoid IP
receptor agonist that provides clinical benefits similar to
available IP receptor agonists; embracing the challenge of
improving health; seeking to bring innovative medicines to
patients; and Arena's focus, plans, goals, strategy, optimism,
expectations, research and development programs, and ability to
discover and develop compounds and commercialize drugs. For such
statements, Arena claims the protection of the Private Securities
Litigation Reform Act of 1995. Actual events or results may differ
materially from Arena's expectations. Factors that could cause
actual results to differ materially from the forward-looking
statements include, but are not limited to, the following:
ralinepag may not be developed, approved for marketing or
commercialized for any disease or condition; risks related to
commercializing drugs, including regulatory, manufacturing, supply
and marketing issues and the availability and use of BELVIQ; cash
and revenues generated from BELVIQ, including the impact of
competition; Arena's revenues will be based in part on estimates,
judgment and accounting policies, and incorrect estimates or
disagreement regarding estimates or accounting policies may result
in changes to Arena's guidance or previously reported results; the
timing and outcome of regulatory review is uncertain, and BELVIQ
may not be approved for marketing when expected or ever in
combination with another drug, for another indication or using a
different formulation or in any other territory for any indication;
regulatory decisions in one territory may impact other regulatory
decisions and Arena's business prospects; government and commercial
reimbursement and pricing decisions; risks related to relying on
collaborative arrangements; the timing and receipt of payments and
fees, if any, from collaborators; the entry into or modification or
termination of collaborative arrangements; unexpected or
unfavorable new data; nonclinical and clinical data is voluminous
and detailed, and regulatory agencies may interpret or weigh the
importance of data differently and reach different conclusions than
Arena or others, request additional information, have additional
recommendations or change their guidance or requirements before or
after approval; data and other information related to any of
Arena's research and development may not meet regulatory
requirements or otherwise be sufficient for (or Arena or a
collaborator may not pursue) further research and development,
regulatory review or approval or continued marketing; Arena's and
third parties' intellectual property rights; the timing, success
and cost of Arena's research and development; results of clinical
trials and other studies are subject to different interpretations
and may not be predictive of future results; clinical trials and
other studies may not proceed at the time or in the manner expected
or at all; having adequate funds; and satisfactory resolution of
litigation or other disagreements with others. Additional factors
that could cause actual results to differ materially from those
stated or implied by Arena's forward-looking statements are
disclosed in Arena's filings with the Securities and Exchange
Commission. These forward-looking statements represent Arena's
judgment as of the time of this release. Arena disclaims any intent
or obligation to update these forward-looking statements, other
than as may be required under applicable law.
Contact: Arena
Pharmaceuticals, Inc.
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Media Contact: Russo
Partners
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Craig M. Audet,
Ph.D., Senior Vice President,
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David Schull,
President
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Operations & Head
of Global Regulatory Affairs
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david.schull@russopartnersllc.com
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caudet@arenapharm.com
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858.717.2310
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858.453.7200, ext.
1612
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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.