Arena Pharmaceuticals Reports Positive Long-Term Data from the Open-Label Extension of the Phase 2 OASIS Trial Evaluating Etrasimod for Treatment of Ulcerative Colitis
- Etrasimod demonstrated clinical response and durable, long-term clinical remission
- Etrasimod demonstrated favorable long-term safety and tolerability
SAN DIEGO, Jan. 7, 2019 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (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
[email protected]
858.210.3636
Media Contact:
Matt Middleman,
MD
LifeSci Public Relations
[email protected]
646.627.8384
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