- Etrasimod 2 mg treatment group achieved
statistical significance in the percentage change in weekly peak
pruritis (PP-NRS), in the change in Dermatology Life Quality Index
(DLQI), and in the change in Patient-Oriented Eczema Measure
(POEM)
- Etrasimod 2 mg was generally well tolerated,
consistent with data in previous trials
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced
additional data at a late-breaking session at the American Academy
of Dermatology VMX Experience. Etrasimod, a novel investigational
drug candidate to treat moderate-to-severe atopic dermatitis (AD),
demonstrated statistical significance in both clinician and patient
reported outcomes in the etrasimod 2 mg treatment group of Arena’s
ADVISE Phase 2b clinical trial. Etrasimod is a highly selective,
once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator.
Topline results from the ADVISE Phase 2b clinical trial were
announced in November 2020. Today’s results were presented by Emma
Guttman-Yassky, MD, PhD, Waldman Professor and Chairwoman, The
Kimberly and Eric J. Waldman Department of Dermatology, Icahn
School of Medicine at Mount Sinai.
“Etrasimod demonstrated clinically meaningful improvements in
both clinical signs of atopic dermatitis and patient reported
outcomes in the etrasimod 2 mg treatment group,” Dr. Guttman said.
“Additionally, patient reported outcomes in this treatment group
were improved as early as 2 weeks after etrasimod treatment was
initiated. These results, combined with the fact that etrasimod was
generally well-tolerated, are promising for this new mechanism of
action for the treatment of atopic dermatitis.”
In the ADVISE trial, Arena Pharmaceuticals evaluated the safety
and efficacy of etrasimod in participants with moderate to severe
eczema as well as to gain insight into design parameters for a
potential pivotal Phase 3 program. Additionally, Arena quantified
participants’ assessments of etrasimod’s efficacy using the peak
pruritis numeric rating scale (PP-NRS), Dermatology Life Quality
Index (DLQI) and Patient-Oriented Eczema Measure (POEM). Given the
statistically significant and clinically meaningful improvements in
PROs in the etrasimod 2 mg treatment group, coupled with the
statistically significant improvements shown on the
clinician-observed vIGA scale in the same treatment group, Arena
Pharmaceuticals continues to expect to advance etrasimod into a
pivotal registrational Phase 3 program for atopic dermatitis.
“The results reported today by Dr. Guttman-Yassky from the
ADVISE trial have demonstrated impressive clinical benefit for
patients living with moderate to severe atopic dermatitis,” said
Paul D. Streck, MD, Senior Vice President, Clinical Development,
and Chief Medical Officer. “Together with a safety profile that was
consistent with previous trials of etrasimod, we believe both the
clinician-based assessments and the patient reported outcomes in
the etrasimod 2 mg treatment group provide a strong basis to
advance etrasimod to a global Phase 3 program as a potential
treatment for atopic dermatitis. If approved, etrasimod has the
potential to bring a novel, easily dosed oral therapy to patients
who currently face limited treatment options for this chronic and
debilitating disease.”
Discussion of Trial
In the trial, 140 participants with chronic, moderate to severe
eczema for at least a year were randomized into three equal cohorts
for etrasimod 1 mg, etrasimod 2 mg, and placebo, treated once daily
for 12 weeks. At the start of the trial, participants showed an
Eczema Area and Severity Index (EASI) equal to or greater than 16,
a vIGA score equal to 3 or more, and were affected by AD over 10%
or more of their body surface. Of the etrasimod 2 mg participants,
29.8% successfully reduced their clinician-reported vIGA at 12
weeks to 0 or 1 (representing “clear” or “almost clear” skin) and
improved by at least 2 points, compared to 13% for placebo
(p=0.0450).
ADVISE also included three dermatology-specific patient reported
outcomes. Participants gave regular evaluations of their peak
pruritis numeric rating scale (PP-NRS), Dermatology Life Quality
Index (DLQI) and Patient-Oriented Eczema Measure (POEM).
- For the PP-NRS, individuals in the etrasimod 2 mg cohort showed
a statistically significant improvement as early as Week 2,
compared to placebo, in their PP-NRS percentage score from baseline
at the start of the trial; the etrasimod 2 mg cohort reported peak
pruritis dropped 15.3% compared to a drop for placebo of only 1.0%
(p=0.0380) at Week 4. This early dramatic drop suggests a rapid
onset of action for etrasimod. The PP-NRS also dropped numerically
a greater amount at Week 12 for the etrasimod 2 mg cohort (34.1%)
than for the placebo cohort (23.9%) (p=0.1549).
- The DLQI measures overall impairment due to a dermatologic
condition on a scale of 0 to 30, with 30 representing an extremely
large effect on a patient’s life. In assessing their overall DLQI,
participants in the etrasimod 2 mg cohort saw statistically
significant declines in their degree of impairment, dropping 7.6
points at Week 12 versus a drop of 4.2 points for placebo
(p=0.0122).
- Arena believes the POEM patient-reported measure of etrasimod’s
efficacy also validated the investigational drug as a potential
treatment for AD. The indexing of POEM indicates that as disease
severity is reduced, the patient’s life improves. In ADVISE, the
etrasimod 2 mg cohort experienced an 8.4 point reduction versus 4
points for placebo (p=0.0045), results that are both clinically and
statistically significant.
Etrasimod was generally well-tolerated in ADVISE, and showed a
safety profile that was consistent with previous trials of
etrasimod. During the trial there were no serious adverse events or
opportunistic or serious infections observed. The most common
adverse events for participants of >5% and greater than placebo
were nausea, constipation, back pain and dizziness.
Arena plans to submit data from the ADVISE trial for publication
in a peer-reviewed journal.
Dr. Guttman-Yassky is a paid consultant and researcher for Arena
Pharmaceuticals.
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 included 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. Etrasimod did not meet the primary endpoint of EASI
change from baseline at week 12 as compared to placebo. A 52-week
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 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 medicines to
patients, and relentlessly execute until it's done.
We are developing a richly diversified portfolio of therapeutic
candidates targeting gastroenterology, dermatology, and cardiology.
Our pipeline includes four investigational medicines in eight
indications and eleven ongoing or planned clinical trials. To fuel
our growth, we are unlocking the value of our historical GPCR
research with a sustainable discovery engine for broad portfolio
expansion.
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
"promising," "potential," "expects," "plan," "ongoing," "may," and
"intended to," and include, without limitation, statements about
the following: etrasimod's potential, including to advance into a
Phase 3 program for atopic dermatitis, to be approved, to be a
novel easily dosed oral therapy option for atopic dermatitis
patients with limited treatment options, to provide systemic and
local effects on specific immune cell types, and to treat multiple
immune-mediated inflammatory diseases; Arena's plans to submit data
from ADVISE for publication in a peer-reviewed journal; and Arena's
purpose, work, understanding, ideas, execution, portfolio,
pipeline, trials, and discovery engine. 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; the duration
and severity of the COVID-19 pandemic, including but not limited to
its impact on Arena's clinical trials and operations, the
operations of Arena's suppliers, partners, collaborators,
licensees, and the 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;
risks and uncertainties relating to cash and revenues that may be
generated from product sales or other sources, including the impact
of competition; 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 Annual Report on Form 10-K for the year
ended December 31, 2020, which was filed with the SEC on February
23, 2021. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210423005379/en/
Corporate Contact: Patrick Malloy Arena Pharmaceuticals,
Inc. Vice President, Investor Relations & Corporate
Communications pmalloy@arenapharm.com 847.987.4878
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