SAN DIEGO, May 26, 2020 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that it has
completed full enrollment of the Phase 2b ADVISE trial evaluating etrasimod, an
investigational next-generation, once-daily, oral, highly selective
sphingosine 1-phosphate (S1P) receptor modulator, for the potential
treatment of moderate-to-severe atopic dermatitis. The trial
enrolled 140 patients at study sites across the United States, Canada and Australia, with a primary efficacy endpoint of
percent change in Eczema Area and Severity Index (EASI) from
baseline to week 12.
"Completing enrollment of the ADVISE trial is a significant
milestone for Arena, and we are extremely proud that the team was
able to meet the high end of our targeted enrollment range,
particularly during these challenging times that our industry and
society are facing," said Preston
Klassen, M.D., M.H.S, Executive Vice President, Head of
Research and Development of Arena. "Based on the potential
best-in-class intrinsic properties of etrasimod, and clinical and
non-clinical evidence seen to date, we are committed to driving its
development in dermatologic conditions. We believe we have the
potential to address the need for a safe and effective oral option
for patients living with atopic dermatitis. We look forward to
continuing with the execution of this Phase 2b trial and the expected availability of topline
data by year end."
"We are very pleased that we have completed enrollment of our
ADVISE trial and that to date we have kept timelines on track for
our global Phase 3 program, ELEVATE UC. On other programs, we
continue to see levels of disruption due to the COVID-19 pandemic;
therefore, we are withdrawing our prior guidance on newly initiated
trials and certain trials in the planning phase, including the
evaluation of etrasimod in Crohn's disease, eosinophilic
esophagitis, or EoE, and alopecia areata, or AA. We are
hopeful that we can initiate both the EoE and AA studies this year
and we are considering options for the Crohn's disease program to
obtain Phase 2 dose-ranging data in 2021. Since the start of
COVID-19, Arena has been vigilant and proactive in dealing with
operational complexities due to the impact of this global
pandemic," stated Amit D. Munshi,
President and Chief Executive Officer of Arena. "Above all else, we
will prioritize patient and employee safety. We intend to
provide periodic updates as we gain additional
clarity."
Program Updates:
- Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial enrollment completed; topline data
expected Q4 2020
- Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis
(UC) ongoing and on track; ELEVATE UC 12 Phase 3 trial expected to
initiate in H2 2020; topline data for both trials expected by year
end 2021
- Etrasimod CULTIVATE Phase 2b
dose-ranging trial in Crohn's disease (CD) initiated and ongoing;
considering options to help facilitate availability of topline data
in 2021; withdrawing previously announced overall program guidance
based on expected COVID-19 impact on trial execution including site
activation and enrollment
- Etrasimod eosinophilic esophagitis (EoE) Phase 2b and alopecia areata (AA) Phase 2 planning
ongoing; initiation in 2020 dependent on COVID-19 situation in
Q3/4
- Olorinab CAPTIVATE Phase 2b trial
in abdominal pain associated with irritable bowel syndrome (IBS-C,
IBS-D) ongoing; experiencing some COVID-19 related impact on trial
enrollment; topline data expected between Q4 2020 and Q1 2021
- APD418 in acute heart failure (AHF) with Fast Track
designation; Phase 1 trial experiencing COVID-19 related impact
with trial temporarily paused; topline data expected Q4 2020
Etrasimod, olorinab, and APD418 are investigational compounds,
not approved for any use in any country.
About Arena Pharmaceuticals
ARENA
Pharmaceuticals is a team with a singular focus – deliver our
important medicines to patients.
In a rapidly changing global market, we work with a sense of
urgency every day to understand the needs of all our stakeholders,
identify bold, sometimes disruptive, ideas to get our medicines to
patients, and relentlessly execute until it's done.
ARENA - Care more, Act differently
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 "expected," "will," "intend,"
"potential," "guidance," and include, without limitation,
statements about the following: Arena's clinical programs,
including clinical study site activations, enrollment of study
subjects, patient safety, study momentum, drug supply, timing of
data readouts, and potential future updates on Arena's clinical
programs; Arena's ability to provide a safe and effective oral
option for patients living with atopic dermatitis; and the
potential of Arena's drug candidates, including potential
best-in-class intrinsic properties. 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, but
are not limited to, the following: clinical trials and other
studies may not proceed at the time or in the manner expected or at
all; the timing and outcome of research, development and regulatory
review is uncertain, and Arena's drug candidates may not advance in
development or be approved for marketing; enrolling patients in
Arena's ongoing and intended clinical trials is competitive and
challenging; the duration and severity of the recent coronavirus
disease (COVID-19) pandemic, including but not limited to the
impact on Arena's clinical operations, the operations of Arena's
suppliers, partners, collaborators, licensees, and capital markets,
which in each case remains uncertain; risks related to developing
and commercializing drugs; Arena may need additional funds to
advance all of its programs, and you and others may not agree with
the manner Arena allocates its resources; risks and uncertainties
relating to cash and revenues that may be generated from product
sales or other sources, including the impact of competition;
Arena's revenues are based in part on estimates, judgment and
accounting policies, and incorrect estimates or disagreement
regarding estimates or accounting policies may result in changes to
Arena's guidance or previously reported results; risks related to
unexpected or unfavorable new data; nonclinical and clinical data
is 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; results of clinical trials
and other studies are subject to different interpretations and may
not be predictive of future results; topline data may not
accurately reflect the complete results of a particular study or
trial; satisfactory resolution of litigation or other disagreements
with others; government and third-party payor actions, including
relating to reimbursement and pricing; risks related to relying on
licenses or collaborative arrangements, including lack of control
and potential disputes; the entry into or modification or
termination of licenses or collaborative arrangements; and Arena's
and third parties' intellectual property rights. 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 Quarterly
Report on Form 10-Q for the quarter ended March 31, 2020, which was filed with the SEC on
May 7, 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
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SOURCE Arena Pharmaceuticals, Inc.