SAN DIEGO, Oct. 19, 2017 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that results
of the Phase 2 clinical study of ralinepag (APD811), the Company's
next-generation, oral, selective prostacyclin receptor (IP)
agonist, intended for the treatment of pulmonary arterial
hypertension (PAH), will be presented at the American College of
Chest Physicians 2017 (CHEST) Annual Meeting, taking place
October 28 – November 1 at the Metro Toronto Convention Centre
in Toronto, Canada.
Presentation Details
Title: Hemodynamic Effects of
the Oral Prostacyclin (IP) Receptor Agonist Ralinepag in Pulmonary
Arterial Hypertension (PAH)
Session: 4060 - Late-breaking
Abstracts 2
Date/Time: Wednesday, November 1st,
3:45 p.m. - 4:00 p.m. EDT
Location: Convention Center - 603
"These Phase 2 results are extremely compelling, particularly
considering the contemporary patient population of our trial in
which 65% patients were already receiving dual background therapies
and all patients were receiving at least one therapy," said
Preston Klassen, M.D., MHS,
Executive Vice President, Research and Development and Chief
Medical Officer of Arena. "We look forward to our upcoming
discussions with the FDA and advancing into a Phase 3 clinical
program."
Prostacyclin deficiency results in increased pulmonary vascular
resistance and is a key factor contributing to disease progression
in PAH ultimately leading to right ventricular failure and death if
untreated. Drugs targeting the prostacyclin receptor should be
considered a cornerstone of optimal PAH therapy as they address a
central pathophysiologic mechanism of the disease. Earlier and
broader use of parenteral and oral prostacyclin analogues have been
limited by inconvenient modes of administration, poor tolerability
and sub-optimal pharmacokinetics. Ralinepag was strategically
designed in an effort to overcome many of these limitations.
The primary efficacy analysis in the Phase 2 study demonstrated
a statistically significant absolute change from baseline in
pulmonary vascular resistance (PVR) with ralinepag compared to
placebo. Ralinepag also demonstrated a numerical improvement in
6-minute walk distance (6MWD). Adverse events observed in the study
were consistent with other prostacyclin receptor agonists used for
the management of PAH.
The ralinepag 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 6MWD, 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 the American College of Chest Physicians
The
American College of Chest Physicians is the global leader in
advancing best patient outcomes through innovative chest medicine
education, clinical research, and team-based care. With more than
19,000 members representing 100+ countries around the world, its
mission is to champion the prevention, diagnosis, and treatment of
chest diseases through education, communication, and research. This
includes connecting health-care professionals to the latest
clinical research and a wide array of evidence-based guidelines
through the CHEST Journal, while also serving as a total education
resource for clinicians through year-round meetings, books, mobile
apps, and live courses in pulmonary, critical care, and sleep
medicine. The first medical association with a clinical simulation
program accredited by the Society for Simulation in Healthcare, the
American College of Chest Physicians also provides hands-on
training through innovative simulation education. The CHEST
Foundation, its philanthropic arm, provides members with grants,
patient education tools, and other resources to help their patients
live and breathe easier.
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 a Phase 2 trial for
pulmonary arterial hypertension (PAH), etrasimod (APD334) in
Phase 2 evaluation for multiple autoimmune indications, 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 "will," "look forward to," "upcoming,"
"intended," "potentially," "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 statements about the upcoming presentation of ralinepag
data, future discussions with the FDA, plans for a Phase 3 trial of
ralinepag, the use of drugs targeting the prostacyclin
receptor, our focus, and the potential of ralinepag and our other
programs and collaborations. For such statements, we claim the
protection of the Private Securities Litigation Reform Act of 1995.
Actual events or results may differ materially from our
expectations. Factors that could cause actual results to differ
materially from the forward-looking statements include: topline
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 trials and other studies may
not proceed at the time or in the manner expected or at all; the
timing and outcome of research, development and regulatory review
is uncertain; enrolling patients in our ongoing and intended
clinical trials is competitive and challenging; 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 and commercializing drugs;
our revenues are based in part on estimates, judgment and
accounting policies, and incorrect estimates or disagreement
regarding estimates or accounting policies may result in changes to
our guidance or previously reported results; government and
third-party payor actions, including relating to reimbursement and
pricing; risks related to relying on collaborative arrangements;
the entry into or modification or termination of collaborative
arrangements; unexpected or unfavorable new data; 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 us or others, request additional
information, have additional recommendations or change their
guidance or requirements before or after approval; our and third
parties' intellectual property rights; satisfactory resolution of
litigation or other disagreements with others; and those factors
disclosed in our filings with the Securities and Exchange
Commission, including our Form 10-Q for the quarter ended
June 30, 2017. These forward-looking
statements represent our judgment as the time of this release. We
disclaim 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.