SAN DIEGO, April 12, 2018 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that data from
a post-hoc analysis of the 22-week Phase 2 clinical study for its
investigative drug candidate ralinepag, a next-generation, oral,
selective and potent prostacyclin receptor agonist in development
for the treatment of pulmonary arterial hypertension (PAH), will be
presented at the International Society for Heart and Lung
Transplantation (ISHLT) 2018 Annual Meeting on April 14. The meeting is taking place
April 11-14 in Nice, France.
Dr. Raymond Benza, Cardiovascular
Institute, Allegheny General Hospital, Pittsburgh, will present the results of an
analysis assessing the impact of ralinepag treatment on mortality
risk, as measured by three risk scoring methodologies (REVEAL,
FPHN and COMPERA), in patients on PAH specific background therapy.
Registry risk scores are used to identify patients at the highest
risk for mortality and assess the impact of treatments on moving
patients into a low-risk category.
"Patients receiving ralinepag experienced improvements in their
mortality risk category using three risk scoring methodologies
developed and utilized globally," said Dr. Benza. "These positive
data further highlight the potential of ralinepag as an effective
treatment of PAH, and I look forward to determining the impact of
ralinepag on clinical outcomes in the Phase 3 clinical
program."
Arena previously announced topline Phase 2 results for ralinepag
in PAH in which the primary efficacy analysis demonstrated a
statistically significant absolute change from baseline in
pulmonary vascular resistance compared to placebo. Ralinepag
also demonstrated numerical improvement in 6-minute walk distance
relative to placebo. Adverse events observed in the study were
consistent with other prostacyclin treatments for the management of
PAH.
Presentation Details
Title: Ralinepag, An
Oral, Selective, Prostacyclin (IP) Receptor Agonist Consistently
Improved Mortality Risk Scores Derived From PAH Registries Across
Three Regions: Phase 2 Study Analysis
When: Saturday, April 14,
1:30 PM - 1:45 PM
About Ralinepag
Ralinepag (APD811) is an oral,
next-generation, selective IP receptor agonist targeting the
prostacyclin pathway and intended for the treatment of pulmonary
arterial hypertension (PAH). Arena discovered and developed this
drug candidate internally. Ralinepag's potency on vasodilation,
inhibition of proliferation of vascular smooth muscle cells, and
inhibition of platelet aggregation, combined with an extended
half-life support its application as a potentially best-in-class
agent for the treatment of PAH. Ralinepag is an investigational
compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is
focused on developing novel, small molecule drugs with optimized
receptor pharmacology and pharmacokinetics designed to deliver
broad clinical utility across several therapeutic areas. Arena's
proprietary pipeline includes potentially first- or best-in-class
programs. The most advanced investigational clinical programs are
ralinepag (APD811), which will be commencing a Phase 3 program for
pulmonary arterial hypertension (PAH), and etrasimod (APD334),
which will be commencing a Phase 3 program for ulcerative colitis
(UC) and which has potential utility for a broad range of immune
and inflammatory conditions. Arena is also evaluating APD371 in
Phase 2 for the treatment of pain associated with Crohn's disease.
In addition, Arena has collaborations with the following
pharmaceutical companies: Everest Medicines Limited (ralinepag and
etrasimod in Greater China and
select Asian countries), Axovant Sciences GmbH (nelotanserin -
Phase 2), Boehringer Ingelheim International GmbH (undisclosed
target - preclinical), and Eisai Co., Ltd. and Eisai Inc.
(BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this
press release are forward-looking statements that involve a number
of risks and uncertainties. These forward-looking statements may be
accompanied by words such as "will," "potential," "look forward
to," "intended for," "potentially," "focused on," "designed to," or
words of similar meaning, or by the fact that they do not relate
strictly to historical or current facts. Such forward-looking
statements include, without limitation, statements about Arena's
upcoming presentation at the ISHLT Annual Meeting; ralinepag,
including relating to its potential to be an effective PAH
treatment or best-in-class, the Phase 3 clinical program in
patients with PAH that is currently in development and potential
findings from that study; and Arena's programs (including their
first- or best-in-class potential), focus and collaborations. 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 that clinical programs may not proceed at the
time or in the manner expected or at all; enrolling patients in our
ongoing and intended clinical trials is competitive and
challenging; results of clinical trials and other studies are
subject to different interpretations and may not be predictive of
future results; the timing and outcome of research, development and
regulatory review is uncertain; topline data may not accurately
reflect the complete results of a particular study or trial;
nonclinical and clinical data are 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;
risks related to unexpected or unfavorable new data; and risks
related to developing and commercializing drugs. 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 (SEC), including but not limited to our Annual Report on
Form 10-K for the year ended December 31,
2017, which was filed with the SEC on March 14, 2018. 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.
Corporate Contact:
Kevin R.
Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.