SAN DIEGO, April 1, 2020 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive
topline data from a Phase 1 clinical study evaluating
controlled-release delivery profiles (CR) for its investigational
agent, etrasimod, a highly selective, once-daily, oral sphingosine
1-phosphate (S1P) receptor modulator.
Results from the study demonstrated that CR delivery enabled a
greater than 75% reduction in the average heart rate effect of
etrasimod during its 4-hour monitoring period, with heart rate
slowing by only low single digits from baseline with no titration.
At additional measurements over 24 hours, the etrasimod CR heart
rate effect was reduced or similar compared to etrasimod. Of note,
the rate of change in heart rate was reduced greater than 50% with
etrasimod CR delivery.
On the basis of these results, Arena will embark on a product
development program to rapidly develop etrasimod CR and integrate
it into multiple, ongoing clinical development
programs. Additionally, a recently filed provisional patent
application for etrasimod CR has the potential to extend patent
coverage beyond that for the composition of matter plus patent term
extension.
"Etrasimod currently has a potential best-in-class profile as a
rapid-acting, non-titrated oral therapy with limited first-dose
heart rate effect. It is exciting that Arena's etrasimod CR program
has the potential to further differentiate this profile," stated
Preston Klassen, MD, MHS, Executive
Vice President, Research and Development at Arena. "This work
builds on Arena's more than twenty-year scientific expertise in
G-protein coupled receptor (GPCR) drug development and has the
potential to improve etrasimod's broad clinical utility. We intend
to launch in ulcerative colitis with etrasimod and expect to move
to etrasimod CR with other ongoing and future development programs
across a broad range of immune-mediated inflammatory diseases."
Conference Call & Webcast Information
Arena will
host a conference call and live webcast with the investment
community today at 4:30 PM ET, to
discuss our data release.
When: Wednesday, April 1, 2020, at
4:30 PM ET
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 2338348
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.
Shortly after the call, a replay of the conference call will be
archived under the events and presentations section of Arena's
website and available for 30 days thereafter.
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, eosinophilic esophagitis, atopic dermatitis, and alopecia
areata.
Etrasimod, in any form, is an investigational compound that is
not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is
uniquely positioned to develop best-in-disease medicines with
optimized efficacy and safety for patients globally. Our drive to
deliver a robust pipeline of novel, transformational medicines is
grounded in two decades of world class G-protein-coupled receptor
(GPCR) discovery research.
It is the breadth and depth of our portfolio, prioritization of
drug development to meet unmet patient needs, strong financial
health and growing, bold-thinking world-class team that gives Arena
the ingredients and passion to build a sustainable, vibrant
next-generation pharmaceutical company.
Forward-Looking Statements
Certain statements in this
press release are forward-looking statements that involve a number
of risks and uncertainties. Such forward-looking statements may be
identified by words such as "designed to," "potentially," "will,"
"potential," "intend to," "expect to," "future," "designed for,"
"may," and "uniquely positioned to" and include statements about:
etrasimod's potential, including to have broad utility in
immune-mediated inflammatory diseases or be best-in-class;
etrasimod CR and its expected clinical benefit and clinical
utility; plans for development of etrasimod and etrasimod CR; the
anticipated benefits of the etrasimod CR program and the
recently-filed provisional patent application for etrasimod CR;
the planned conference call and live webcast with the
investment community; and Arena's position, drive, portfolio,
prioritization, financial position, team, and building of the
company. 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 risk that topline data is
based on preliminary analysis of key data, and such data or
analysis may change following a more comprehensive review of the
data, and such topline data may not accurately reflect the complete
results of a particular study or trial; the risk that the results
of clinical trials and other studies are subject to different
interpretations and may not be predictive of future results; the
risk that regulatory agencies may interpret or weigh the importance
of data differently and reach different conclusions than Arena or
others, or request additional information, or 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; the risk that etrasimod, etrasimod
CR or Arena's other drug candidates may not advance in development
or be approved for marketing; the risk that clinical trials and
other studies may not proceed at the time or in the manner expected
or at all; and the risk that the provisional patent application for
etrasimod CR may not result in an issued patent and, if issued, may
not have a patent term extending beyond Arena's existing etrasimod
patent portfolio. 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 (SEC), including but
not limited to Arena's Annual Report on Form 10-K for the year
ended December 31, 2019, which was
filed with the SEC on February 27,
2020. 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:
Megan E.
Knight
Arena Pharmaceuticals, Inc.
Director, Investor Relations
mknight@arenapharm.com
858.210.3635
Arena Media Contact:
IR@arenapharm.com
858-453-7200
View original content to download
multimedia:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-announces-positive-topline-data-for-new-development-program---etrasimod-controlled-release-cr-301033578.html
SOURCE Arena Pharmaceuticals, Inc.