SAN DIEGO, March 1, 2018 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA), will present Phase 1 and
preclinical data for the investigative drug candidate APD371 at the
American Pain Society (APS) Annual Scientific Meeting on
March 6.
These data support the unique profile of APD371, a peripherally
restricted, highly–selective, full agonist of the cannabinoid 2
(CB2) receptor. APD371 was evaluated in Phase 1 studies to assess
the safety, tolerability and pharmacokinetics of a single ascending
dose (SAD) or multiple ascending doses (MAD) in healthy volunteers.
In these studies, APD371 was safe and well-tolerated. All adverse
events were classified as mild, the most common of which were
headache and nausea; one subject discontinued treatment due to
adverse events and there were no serious adverse events. APD371 did
not exhibit psychotropic effects that are commonly seen with
cannabinoids. APD371 showed stable pharmacokinetics with no
accumulation in blood plasma following repeated doses. In parallel
preclinical studies, APD371 demonstrated full efficacy at human and
rodent CB2 receptors in recombinant receptor cAMP, β-arrestin, and
internalization pathways, and has an over thousand-fold selectivity
over the cannabinoid 1 (CB1) receptor.
APD371 is currently being evaluated in a Phase 2
proof-of-concept trial for visceral pain associated with Crohn's
disease.
"We are excited to present these initial APD371 preclinical and
Phase 1 study data at the American Pain Society Summit," said Arena
Pharmaceuticals Chief Medical Officer, Dr. Preston Klassen. "These studies establish that
APD371 has the potential to be a transformative, non-opioid pain
medication and we look forward to a readout from our Phase 2 study
evaluating the efficacy of APD371 in treating pain associated with
Crohn's disease."
The Scientific Summit will take place in Anaheim, Calif. on March 4-6, 2018.
Presentation Details
Title: APD371: A Potent,
Highly Selective, Full Agonist of the Human CB2 Receptor with
Sustained Analgesic Effects in Rodents
Poster Number: 100
Date/Time: Tuesday, March 6, 11:30 a.m. – 12:30 p.m.
PST
Location: Disneyland Hotel, Experience Exchange room
Title: Safety, Tolerability, and Pharmacokinetics of
APD371, a Highly Selective CB2 Agonist, in Healthy Adults
Poster Number: 286
Date/Time: Tuesday, March 6,
11:30 a.m. – 12:30 p.m. PST
Location: Disneyland Hotel, Experience Exchange room
About APD371
APD371 is an orally available,
peripherally restricted, highly-selective, full agonist of the
cannabinoid 2 (CB2) receptor. APD371 is an internally discovered
investigational drug candidate that Arena is exploring for
development in several indications, including visceral pain. This
compound, through its selectivity for CB2, is designed to provide
pain relief without psychotropic effects and without the potential
for dependence or abuse. APD371 is currently in a Phase 2
evaluation for treatment of pain associated with Crohn's
disease.
APD371 is an investigational compound 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 is in Phase 2 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," "exploring," "designed to," "focused on," "potentially,"
"may," 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 APS Summit; APD371,
including relating to its potential to be a transformative
non-opioid pain medication and its ongoing Phase 2 clinical trial
for pain associated with Crohn's disease; and Arena's position for
the future, opportunities for catalysts, 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, including but not limited to our Annual Report on Form
10-K which was filed on March 15,
2017 and our Quarterly Report on Form 10-Q which was filed
on November 8, 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.