SAN DIEGO, Nov. 9, 2020 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced topline
results from the Phase 2b ADVISE
clinical trial evaluating etrasimod, a highly selective,
once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator,
for the treatment of moderate-to-severe atopic dermatitis (AD).
"Today is an important day for Arena as we achieved our key
objectives for the ADVISE trial which were to evaluate safety and
efficacy of etrasimod in a dermatologic population, and to inform
dose and design decisions for a pivotal Phase 3 program. We believe
the clinical benefits of etrasimod in this trial were impressive,
especially given the challenges of conducting a Phase 2 trial with
a novel MOA in atopic dermatitis," stated Chris Cabell, MD, MHS, FACC, Executive Vice
President, Head of Research and Development, and Chief Medical
Officer at Arena. "We look forward to advancing etrasimod into a
Phase 3 program in atopic dermatitis. We would like to thank the
patients, trial coordinators and investigators who participated in
this important trial."
In the ADVISE trial, the participants were representative of a
moderate patient population (82.9% baseline vIGA 3) which
constitutes upward of 40% of the AD market1. In the
primary analysis, nearly one-third of participants in the 2 mg
etrasimod group achieved clear or almost clear skin, as defined by
the validated Investigator Global Assessment (vIGA) – the FDA
endpoint for Phase 3 registration. Importantly, the vIGA
improvement was statistically significant vs. placebo at 12 weeks.
Across the Eczema Area and Severity Index (EASI), EASI-75 and peak
change in pruritis, etrasimod 2 mg demonstrated early and
statistically significant effect at week 4. Etrasimod did not meet
the Ph 2b primary endpoint of EASI
change from baseline at week 12 as compared to placebo.
Overall, the 12-week study showed no plateau of effect, and the
safety profile was consistent with previous trials of etrasimod
including low first dose heart rate effect with no titration, and
no serious adverse events (SAEs) across the groups. In the
etrasimod groups, there were no cases of venous thromboembolic
events, opportunistic or serious infections, macular edema,
conjunctivitis, acne or herpes zoster. Additionally, none of the
other adverse events commonly associated with first-generation S1P
receptor modulators were seen in this trial.
Between weeks 4-8, the trial was impacted by unwarranted dose
interruption (not related to drug safety) in 19% (n=9) of the
etrasimod 2 mg group. Adjusting for this dose interruption – a
post-hoc Completer Analysis with participants receiving full
therapeutic exposure – etrasimod 2 mg showed statistically
significant effect on the EASI score compared to placebo (weeks 4
and 12), EASI-75 at week 4, vIGA at week 12 and pruritis through
week 8.
Importantly, the analysis of the participant cohort with dose
interruption showed diminished clinical effect upon withdrawal
and a recapture of effect upon reinstatement of study drug
consistent with the pharmacodynamics (PD) of etrasimod.
Based on the compelling profile in this moderate AD population,
etrasimod will be proceeding into a Phase 3 registrational
program.
"I was encouraged by etrasimod's ability to
demonstrate early differentiation from placebo and
continued improvement to week 12 and a favorable safety
profile. These data support moving forward to the next stage of
clinical development," stated Emma
Guttman, MD, PhD, Sol and
Clara Kest Professor and the Incoming Chair at the
Department of Dermatology, Director of the Center for Excellence in
Eczema, and Director of the Laboratory of Inflammatory Skin
Diseases at the Icahn School of Medicine at Mount Sinai Medical
Center, New York.
"The results of the ADVISE trial are promising. In particular
the efficacy as measured by improvement in vIGA will be important
in determining the dose and design of the Phase 3 registrational
program," said Jonathan I.
Silverberg, MD, PhD, MPH, Associate Professor of
Dermatology, Director of Clinical Research, and Director of Patch
Testing, at the George Washington University
School of Medicine and Health Sciences.
Arena plans to submit additional data from the ADVISE trial to
future medical meetings and for publication in a peer-reviewed
journal.
1 DRG AD Disease Landscape & Forecast 2019;
Barbarot S, 2018/ Ronmark E, 2012; Spherix Q2 2020 Report
(physician survey)
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 the topline data
When: Monday, November 9, 2020, at 4:30 PM ET
Dial-in: (877) 643-7155 (United States) or (914) 495-8552
(International)
Conference ID: 6166976
Please join the conference call at least 20 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 ADVISE
ADVISE was a Phase 2b multicenter, randomized, double-blinded,
placebo-controlled trial to assess the safety and efficacy of
once-daily etrasimod in subjects with moderate-to-severe atopic
dermatitis. The primary endpoint measured was percent change in
Eczema Area and Severity Index (EASI) from baseline to week 12,
followed by a 4-week follow-up observation period. Secondary
endpoints include the proportion of participants achieving EASI-75,
proportion of participants with a validated Investigator Global
Assessment (vIGA) 0 to 1, and percent change in peak pruritis. The
ADVISE trial enrolled approximately 140 subjects and was conducted
in study sites across the United
States, Canada and
Australia. An open-label extension
of the ADVISE trial is ongoing.
About Atopic Dermatitis
Atopic dermatitis (AD) is a
serious, chronic immune-mediated disease in which symptoms vary,
but often include severe dry skin, itching, patches, swollen skin
and raised bumps which may leak fluid.
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 is intended to provide 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 is an investigational compound that is not approved
for any use in any country.
About Arena Pharmaceuticals
ARENA
Pharmaceuticals is a team with a singular purpose – 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.
Drs. Guttman and Silverberg are paid consultants of Arena.
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 "believe," "look forward," "promising,"
"will," "plans," "may," "designed for," and "potential," and
include, without limitation, statements about the following:
Arena's plans to advance etrasimod into a Phase 3 registrational
program in atopic dermatitis, the potential clinical benefits of
etrasimod, Arena's plans to submit additional data from the ADVISE
study for publication in a peer-reviewed journal, and Arena's
purpose, work, understanding, ideas, and execution. 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: topline
data may not accurately reflect the complete results of a
particular study or trial; results of clinical trials and other
studies are subject to different interpretations and may not be
predictive of future results; 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 participants in
Arena's ongoing and intended clinical trials is competitive and
challenging; the duration and severity of the 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 will need additional funds to advance
all of its programs, and you and others may not agree with the
manner Arena allocates its resources; the impact of competition;
risks related to unexpected or unfavorable new data; the risk that
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;
satisfactory resolution of litigation or other disagreements with
others; and risks related to the enforcement of 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 Annual Report on Form 10-K for
the year ended December 31, 2019,
which was filed with the SEC on February 27,
2020, and Arena's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020, which
was filed with the SEC on August 5,
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 Contacts:
Patrick Malloy
Arena Pharmaceuticals, Inc.
Vice President, Investor Relations & Corporate
Communications
pmalloy@arenapharm.com
847.987.4878
Megan E. Knight
Arena Pharmaceuticals, Inc.
Director, Investor Relations
mknight@arenapharm.com
858.210.3635
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SOURCE Arena Pharmaceuticals, Inc.