- Evaluating 2 mg and 3 mg etrasimod in study
participants with moderate to severe Crohn's Disease (CD)
- Topline data from CULTIVATE Study A on track
for Q2 2022
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that
it has achieved target enrollment in Study A of the Phase 2/3
CULTIVATE trial evaluating the safety and efficacy of etrasimod, a
highly selective, once-daily, oral sphingosine 1-phosphate (S1P)
receptor modulator, in participants with moderate to severe Crohn's
disease (CD). CULTIVATE Study A reached target enrollment of 70
study participants to assess etrasimod 2 mg and 3 mg in
participants with CD.
"Crohn's disease patients have an intense need for additional
therapeutic options, particularly for a safe and effective oral
option," said Doug Manion, MD, FRCP (C) Executive Vice President,
Research & Development at Arena. "We are already progressing
etrasimod into the next study in the CULTIVATE program and look
forward to seeing the topline data from Study A in Q2 2022."
About CULTIVATE and Study A
CULTIVATE is a Phase 2/3 trial consisting of five studies
designed to evaluate the efficacy, safety, and tolerability of oral
etrasimod as therapy in adult participants with moderate to severe
Crohn's disease (CD) who are refractory or intolerant to at least
one of the current therapies for CD. CULTIVATE is being conducted
in approximately 27 countries globally.
CULTIVATE Study A is a Phase 2 randomized, double-blind trial to
assess the efficacy, safety, and tolerability of etrasimod 2 mg and
3 mg once-daily in participants with moderate to severe CD to
support the selection of an induction and maintenance dose(s) for
Phase 3. Study A consists of a 14-week induction and a 52-week
extension period. The primary outcome measures is number and
severity of adverse events. Key secondary measures include efficacy
as measured by the Simple Endoscopic Score in CD (SES-CD) and the
Crohn's Disease Activity Index (CDAI).
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 receptors 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.
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 "on
track," “designed to,” “expect,” “may,” “lead to,” and
“potentially,” and include, without limitation, statements about
the potential benefits of the CULTIVATE trial, the timing of
topline data from CULTIVATE Study A, the potential benefits of
etrasimod, 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: 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 and the operations of Arena’s
suppliers, partners, collaborators, licensees, which in each case
remains uncertain; risks related to developing and commercializing
drugs; 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; 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 under the heading “Risk Factors” in
Arena’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021, filed with the SEC on November 4, 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/20211119005228/en/
Corporate Contacts: Patrick Malloy Arena Pharmaceuticals,
Inc. Vice President, Investor Relations & Corporate
Communications pmalloy@arenapharm.com 847.987.4878
Sara Doran Arena Pharmaceuticals, Inc. Associate Director,
Investor Relations & Corporate Communications
sdoran@arenapharm.com
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