SAN DIEGO, Nov. 6, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) presented new data evaluating
the human mass balance, metabolic disposition, and pharmacokinetics
(PK) of etrasimod in healthy adult male volunteers. Etrasimod
is an investigational next-generation, once-daily, oral, highly
selective sphingosine 1-phosphate (S1P) receptor
modulator. The results were presented at the American
Association of Pharmaceutical Scientists (AAPS) 2019 PHARMSCI 360
Meeting in San Antonio, Texas.
"Results from this human mass balance study confirm that
etrasimod is slowly and extensively metabolized via multiple
metabolic pathways and demonstrate no exposure from any major
metabolites. Additionally, multiple metabolic pathways for
etrasimod significantly reduces the likelihood of any unwanted
potential drug-drug interactions," said Preston Klassen, MD, MHS, Executive Vice
President, Head of Research & Development at Arena. "These
highly favorable PK properties of etrasimod support the
best-in-disease safety demonstrated in the Phase 2 OASIS study
results. We look forward to the continued development of this
potential new oral treatment option in the ongoing and planned
late-stage programs in IBD, and the ongoing Phase 2 program in
atopic dermatitis."
Etrasimod Presentation Details:
Title: Mass
Balance, Metabolic Disposition, and Pharmacokinetics of
[14C]Etrasimod Following Oral Administration to Healthy
Male Volunteers
Poster ID: T1530-13-83
This poster is among the few selected top presentations to be
featured at an AAPS Special Poster Collections event.
These data will also be included as part of a poster
presentation at the upcoming American Society for Clinical
Pharmacology & Therapeutics (ASCPT) 2020 Annual Meeting.
About Etrasimod
Etrasimod (APD334) is a
next-generation, once-daily, oral, highly selective sphingosine
1-phosphate (S1P) receptor modulator discovered by Arena and
designed for optimized pharmacology and engagement of S1P receptor
1, 4, and 5 which may lead to an improved efficacy and safety
profile.
Etrasimod provides systemic and local effects on specific immune
cell types and has the potential to treat multiple immune-mediated
inflammatory diseases including ulcerative colitis, Crohn's
disease, and atopic dermatitis.
Etrasimod is an investigational compound that is not approved
for any use in any country.
About Arena Pharmaceuticals
Arena
Pharmaceuticals is driven to deliver novel, transformational
medicines with optimized pharmacology to patients globally. Arena's
proprietary pipeline includes multiple potentially first- or
best-in-class assets with broad clinical utility. Arena is
evaluating etrasimod (APD334) in a broad range of
immune-mediated inflammatory diseases, including in later-stage
programs in inflammatory bowel disease (IBD), a Phase 2 program in
atopic dermatitis (AD), and in programs for other indications.
Arena is also evaluating olorinab (APD371) in a Phase 2
program for gastrointestinal pain. Arena continues to assess other
earlier research and development stage drug candidates,
including APD418 for decompensated heart failure.
Arena has additional license agreements and partnerships,
including with United Therapeutics (ralinepag in a Phase
3 program for pulmonary arterial hypertension), Everest
Medicines Limited (etrasimod in Greater China and
select Asian countries), Boehringer Ingelheim International
GmbH (undisclosed target – preclinical), Outpost
Medicine, LLC (undisclosed target – Phase 1), 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
identified by introductory words such as "suggest," "potential,"
"look forward to," "planned," "will," "designed for," "may,"
"driven to," "potentially," "evaluating," 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 etrasimod, including
its potential to have low likelihood of unwanted potential
drug-drug interactions, to have best-in-disease safety, to continue
to be developed in ongoing and planned programs in IBD and atopic
dermatitis, to become a new oral treatment option, to have
optimized pharmacology and receptor engagement, to have an improved
efficacy and safety profile, and to treat multiple immune-mediated
inflammatory diseases including ulcerative colitis, Crohn's
disease, and atopic dermatitis; Arena's drive; and the potential of
Arena's assets, programs, licenses, and partnerships. 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, without limitation, the following: results of
clinical trials and other studies, such as the human mass balance
study discussed in this press release, are subject to different
interpretations and may not be predictive of future results;
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; 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; clinical trials and other
studies 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; risks related to unexpected or
unfavorable new data; risks related to developing and
commercializing drugs; risks related to relying on partners and
other third parties; Arena's and third parties' intellectual
property rights; and satisfactory resolution of litigation or other
disagreements with others. 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. 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, MD
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.