SAN DIEGO, June 29, 2017 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA), today announced the
completion of a Phase 1 comparative bioavailability study
evaluating the pharmacokinetic (PK) profile of extended release
(XR) ralinepag compared to the immediate release (IR)
formulation in healthy adults.
While the IR formulation currently in clinical investigation is
believed to provide continuous exposure, the XR formulation, when
administered once-daily, may further ralinepag's ability to achieve
a PK profile similar to intravenous prostacyclin therapy.
The Phase 1 trial evaluated the safety, tolerability and PK of
ralinepag XR tablets, given as single daily doses, at three dose
levels, to 12 healthy adult subjects. Subjects also received single
doses of ralinepag IR capsules. PK results showed the once-daily XR
tablet to reduce the maximum plasma concentration (Cmax) of
ralinepag compared to the IR capsule, while maintaining similar
total plasma concentrations.
The most common treatment-emergent adverse events with ralinepag
XR were similar to those seen in previous studies of ralinepag IR
in healthy volunteers.
Dr. Preston Klassen, Arena's
Executive Vice President, Research and Development and Chief
Medical Officer commented, "We believe the results from this trial
support the delivery of ralinepag as a single daily oral dose for
patients with pulmonary arterial hypertension. We will evaluate
these data further in the context of the Phase 2 data with
ralinepag IR that are expected in July."
About Ralinepag
Ralinepag (APD811), is an oral,
next-generation, selective IP receptor agonist targeting the
prostacyclin pathway for the treatment of pulmonary arterial
hypertension (PAH). Arena discovered and developed this
investigational 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.
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.
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) in 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," "believed,"
"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 ralinepag's exposure and
ability to achieve a profile similar to IV prostacyclin therapy;
the trial results and the efficacy, dosing and delivery of
ralinepag; future evaluation and development of ralinepag; timing
of expected Phase 2 data of ralinepag; 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 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 regulator approval and commercializing drugs;
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; Arena's and third parties'
intellectual property rights; 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; 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.