SAN DIEGO, July 10, 2017 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA), today announced positive
Phase 2 results for ralinepag, an investigational, long-acting,
orally administered prostacyclin receptor agonist under development
for the treatment of pulmonary arterial hypertension (PAH).
In this 61-patient study, the primary efficacy analysis
demonstrated a statistically significant absolute change from
baseline in pulmonary vascular resistance (PVR) compared to
placebo. Ralinepag also demonstrated numerical improvement in
6-minute walk distance (6MWD).
Ralinepag improved median PVR by 163.9 dyn.s.cm-5
from baseline compared to a 0.7 dyn.s.cm-5 worsening
from baseline in the placebo arm (P=0.02). Patients treated
with ralinepag had a 29.8% improvement in PVR compared to the
placebo arm (P=0.03) and a 20.1% improvement in PVR compared to
baseline. Additionally, adverse events observed in the study were
consistent with other prostacyclin treatments for the management of
PAH, with headache, nausea, diarrhea, jaw pain and flushing being
the most commonly reported adverse events. The company plans to
present full study results at future medical congresses.
"The positive outcome of this Phase 2 trial in a contemporary
PAH patient population is an important milestone in the development
of ralinepag for the treatment of patients suffering from this
grievous illness," stated Preston
Klassen, M.D., MHS, Executive Vice President, Research and
Development and Chief Medical Officer of Arena. "It is
exciting to see the positive nonclinical pharmacological profile
translating into potentially the first oral prostacyclin therapy
that may approach consistent therapeutic levels without the
complexity of parenteral (IV) therapy. These data give us
confidence to move expeditiously toward a Phase 3 clinical
program."
Vallerie McLaughlin, M.D.,
Kim A. Eagle MD Endowed Professor of
Cardiovascular Medicine at the University of
Michigan and Director of the Pulmonary Hypertension Program,
added, "PAH is a complex and serious disease, often with a poor
prognosis despite the use of currently available treatments. New
therapeutic options to manage patients with PAH are needed. The
results of this Phase 2 study of ralinepag, in patients already
receiving, in most cases, multiple background therapies, showed a
clinically meaningful improvement in PVR, a well-established
indicator of treatment benefit, believed to be correlated with
long-term clinical outcomes in patients with PAH."
Conference Call & Webcast Information
The Arena management team will host a conference call and live
webcast with slides with the investment community
today, Monday, July 10, 2017, at 4:30 p.m. EDT to
discuss the information in this press release.
When: July 10, 2017, 4:30 p.m. EDT
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 52490461
Please join the conference call at least 10 minutes early to
register.
You can access the live webcast under the investor relations
section of Arena's website at: www.arenapharm.com. A
replay of the conference call will be archived under
the investor relations section of Arena's website for 30
days shortly after the call.
About the Trial
The Phase 2 study was a randomized, double-blind,
placebo-controlled, dose-ranging study in 61 adult patients with
PAH, WHO/NYHA functional class II-IV. Study medication was
titrated over 9 weeks, followed by a 13-week treatment period. The
primary efficacy analysis was absolute change from baseline in
pulmonary vascular resistance (PVR) at week 22. Additional
endpoints included change from baseline in 6-minute walk test,
proportion of subjects who exhibit clinical worsening and safety
and tolerability. Patients who completed week 22 could transition
to an open-label ralinepag extension study.
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 Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) is a rare, chronic,
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. Current treatment of PAH falls within four distinct
therapeutic classes: endothelin receptor antagonists (ERAs),
phosphodiesterase-5 (PDE-5) inhibitors, prostacyclin analogues and
soluble guanylate cyclase (SGc) stimulators. The available
therapies have positive effects in PAH, but they do not provide a
cure, and in many patients the disease will progress despite
treatment.
About Arena Pharmaceuticals
Arena Pharmaceuticals is a biopharmaceutical company focused on
developing novel, small molecule drugs with optimized receptor
pharmacology designed to deliver broad clinical utility across
multiple therapeutic areas. Our proprietary pipeline includes
potentially first- or best-in-class programs for which we own
global commercial rights. Our three most advanced
investigational clinical programs are ralinepag (APD811) which has
completed Phase 2 evaluation for pulmonary arterial hypertension
(PAH), etrasimod (APD334) in Phase 2 evaluation for multiple
autoimmune indications including ulcerative colitis (UC), and
APD371 in Phase 2 evaluation for the treatment of pain associated
with Crohn's disease. In addition, Arena has collaborations with
the following pharmaceutical companies: Eisai Co., Ltd. and Eisai
Inc. (commercial stage), Axovant Sciences (Phase 2 candidate), and
Boehringer Ingelheim International GmbH (preclinical
candidate).
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. These
statements may be identified by introductory words such as "may,"
"expects," "plan," "believe," "will," "achieve," "anticipate,"
"would," "should," "subject 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 statements
regarding the importance of ralinepag's Phase 2 data, ralinepag's
potential and plans for ralinepag's Phase 3 development; and
Arena's focus, goals, strategy and clinical programs. 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: top-line data may not accurately reflect the
complete results of a particular study or trial; results of
clinical trials and other studies are subject to different
interpretations and may not be predictive of future results;
clinical and nonclinical 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; the timing and outcome of
research, development and regulatory review is uncertain; we expect
to need additional funds to advance all of our programs, and you
and others may not agree with the manner we allocate our resources;
our drug candidates may not advance in development or be approved
for marketing; risks related to developing, seeking regulatory
approval and commercializing drugs; unexpected or unfavorable new
data; Arena's and third parties' intellectual property rights;
clinical trials and other studies may not proceed at the time or in
the manner expected or at all; data and information related to our
programs may not meet regulatory requirements or otherwise be
sufficient for further development, regulatory review, partnering
or approval; competition; risks related to commercializing drugs,
including regulatory, manufacturing, supply and marketing issues
and their availability and use; reimbursement and pricing
decisions; risks related to relying on partners and other third
parties; and satisfactory resolution of litigation or other
disagreements; and those factors disclosed in Arena's filings with
the Securities and Exchange Commission, including our Form 10-Q for
the quarter ended March 31, 2017.
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.