SAN DIEGO, Jan. 7, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive data
from the open-label extension (OLE) of the Phase 2 OASIS trial of
its investigational drug candidate etrasimod, a next-generation,
oral, selective sphingosine 1 phosphate (S1P) receptor modulator in
development for the treatment of moderate to severely active
ulcerative colitis (UC). Overall, etrasimod demonstrated durable,
long-term clinical remission and was generally safe and well
tolerated in this trial.
Open-Label Extension of Phase 2 OASIS Trial
Design
This was a 34-week open-label extension evaluating
the long-term safety, tolerability and efficacy of etrasimod in
118 subjects (84% of OASIS study completers) who completed the
12-week Phase 2 OASIS randomized, placebo-controlled trial. Of the
118 subjects, 105 received only 2 mg etrasimod during the OLE study
regardless of previous study treatment. Key efficacy measurements
included clinical response, clinical remission, and endoscopic
improvement at end of treatment (46 weeks).
Key Efficacy Measurements
Of the subjects who
completed 2 mg etrasimod treatment during the OLE study (n=84), 79%
achieved clinical response, 39% achieved clinical remission, and
51% had endoscopic improvement at the end of the OLE study.
For OLE study completers who received 2 mg etrasimod in the
original Phase 2 OASIS trial (n=22), 82% experienced clinical
response, 50% were in clinical remission, and 55% had endoscopic
improvement at the end of the OLE study.
Among subjects achieving clinical response or clinical
remission on 2 mg etrasimod at 12 weeks in OASIS, sustained
treatment effect over 46 weeks was observed, with 93% experiencing
sustained clinical response and 75% experiencing sustained clinical
remission at both 12 and 46 weeks.
Key Safety Measurements
Etrasimod demonstrated a
favorable long-term safety profile; adverse events in the OLE study
were generally mild to moderate in severity and no new safety
findings were noted. Impact on heart rate and atrioventricular (AV)
conduction was minimal throughout the study with no
discontinuations from study related to bradycardia or AV block.
The Company plans to present full study results at future
medical congresses.
"We are pleased with the long-term safety and efficacy that
etrasimod has demonstrated in the open-label extension of our Phase
2 OASIS trial," said Preston
Klassen, MD, MHS, Executive Vice President, Research and
Development and Chief Medical Officer of Arena. "These data further
support our belief in etrasimod as an important future therapy in
inflammatory bowel disease and our strong commitment to improve the
lives of patients suffering from these grievous conditions."
"There remains a significant unmet need for new oral therapies
for ulcerative colitis. It is encouraging to see longer-term safety
and tolerability data and durable treatment effects of etrasimod,
which are important for patients suffering from this chronic
condition," said Bruce E. Sands, MD,
Mount Sinai Hospital and the Icahn School of Medicine, Mt. Sinai, New York. "These results further
support the initiation of the Phase 3 clinical development program
to further evaluate etrasimod in ulcerative colitis."
About Etrasimod
Etrasimod (APD334), is a next
generation, oral, selective sphingosine 1 phosphate (S1P) receptor
modulator, discovered by Arena, designed to provide systemic and
local cell modulation by selectively targeting S1P receptor
subtypes 1, 4 and 5. Etrasimod has therapeutic potential in immune
and inflammatory-mediated diseases such as ulcerative colitis,
Crohn's disease, primary biliary cholangitis (PBC) and atopic
dermatitis. S1P receptors have been demonstrated to be involved in
the modulation of several biological responses, including
lymphocyte trafficking from lymph nodes to the peripheral blood. By
isolating subpopulations of lymphocytes in lymph nodes, fewer
immune cells are available in the circulating blood to effect
tissue damage.
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 and pharmacokinetics to patients globally. Arena's
proprietary pipeline includes multiple potentially first- or
best-in-class assets with broad clinical utility.
Etrasimod (APD334), with potential utility in a broad range of
immune and inflammatory conditions, is being evaluated in
later-stage clinical programs in ulcerative colitis (UC) and
Crohn's disease, as well as in programs for primary biliary
cholangitis (PBC) and atopic dermatitis. Ralinepag (APD811) is
being evaluated in a Phase 3 program for pulmonary arterial
hypertension (PAH). 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.
In addition, Arena has several partnerships including with
Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries),
Boehringer Ingelheim International GmbH (undisclosed target -
preclinical), Outpost Medicine, LLC (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
identified by introductory words such as "evaluating," "in
development for," "belief," "future," "commitment to," "designed
to," "potential," "driven to," "potentially," "being evaluated
for," 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
regarding the intention and plan to progress etrasimod's
development; etrasimod's potential, including to be an important
future therapy in inflammatory bowel disease, to satisfy a
significant unmet medical need, to have utility in a broad range of
immune and inflammatory-mediated diseases such as ulcerative
colitis, Crohn's disease, PBC, and atopic dermatitis, and to
modulate several biological responses, including lymphocyte
trafficking from lymph nodes to the peripheral blood; Arena's
drive; and the potential of Arena's assets, programs, 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, without limitation, the
following: the announced data are based on an interim analysis of
certain key measurements, and such interim data or analysis may
change following a more comprehensive review of the data, and such
interim data or analysis may not accurately reflect the final
results of the study; the reported-on trial was not a
placebo-controlled study; results of clinical trials and other
studies 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; 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 (SEC), including but not limited to Arena's most recent
Annual Report on Form 10-K and Quarterly Report on Form 10-Q. 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.