SAN DIEGO, Nov. 10, 2017 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA), today announced that it
has completed full enrollment in the etrasimod Phase 2 study in
ulcerative colitis (UC). Etrasimod is an
investigational-stage, oral, next-generation,
sphingosine-1-phosphate (S1P) receptor modulator with improved
pharmacology and pharmacokinetics intended for the treatment of
autoimmune diseases. The study enrolled 157 patients at sites
globally.
"A significant unmet need exists across a range of autoimmune
conditions including UC, and we are excited to have fully enrolled
this study for etrasimod, meeting the high-end of our targeted
range," said Preston Klassen, M.D.,
MHS, Executive Vice President, Research and Development and Chief
Medical Officer of Arena. "We look forward to the
availability of data from this Phase 2 trial in the first quarter
of 2018. Given etrasimod's oral route of administration and
optimized profile, we believe it has the potential to deliver broad
clinical utility."
The study is a 12-week, randomized, double-blind,
placebo-controlled, parallel-group, dose-ranging trial evaluating
safety and tolerability. Efficacy endpoints include improvement in
the Mayo clinical score (3-component, total), response, remission
and mucosal healing versus placebo, and dose response. The study
enrolled patients with moderate to severe UC (3-component Mayo
score of 4-9 that includes endoscopic sub score >2, rectal
bleeding score >1).
About Etrasimod
Etrasimod (APD334), is an oral, next generation, 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, while
avoiding subtypes 2, 3. Etrasimod exhibits potentially best in
class pharmacokinetics and pharmacodynamics with rapid onset of
action and rapid recovery of t-lymphocytes. Selective binding with
S1PR1 is believed to inhibit a specific subset of activated
lymphocytes from migrating to sites of inflammation. The result is
a reduction of circulating T and B lymphocytes that leads to
anti-inflammatory activity. Importantly, immune surveillance is
maintained. The receptor subtypes 4, 5 exhibit similar
activity on additional proliferating immune cell types. Optimized
pharmacology and pharmacokinetics may allow superior clinical
utility across a broad range of autoimmune conditions.
Etrasimod is an investigational compound not approved for any
use in any country.
About Autoimmune Diseases
Autoimmune diseases are
characterized by an inappropriate immune response against
substances and tissues that are normally present in the body. In an
autoimmune reaction, a person's antibodies and immune cells target
healthy tissues, triggering an inflammatory response. Reducing the
immune and/or inflammatory response is an important goal in the
treatment of autoimmune disease.
About Ulcerative Colitis
Ulcerative colitis is a
chronic disease that affects the large intestine. The innermost
lining of the large intestine becomes inflamed and ulcers may form
on the surface, which can cause symptoms such as frequent bowel
movements, diarrhea and bloody stools. The inflammation is usually
found in the rectum and can include all or a portion of the colon.
Currently available treatment options have limitations in terms of
side effects, patient response, efficacy and administration. We
believe that an effective, oral, selective S1P receptor modulator
that provides clinical benefits without current limitations has the
potential to improve treatment for patients with ulcerative
colitis.
About Arena Pharmaceuticals
Arena Pharmaceuticals is a
biopharmaceutical company focused on developing novel, small
molecule drugs with optimized receptor pharmacology designed to
deliver broad clinical utility across multiple therapeutic areas.
Our proprietary pipeline includes potentially first- or
best-in-class programs for which we own global commercial rights.
Our three most advanced investigational clinical programs are
ralinepag (APD811) which has completed a Phase 2 trial for
pulmonary arterial hypertension (PAH), etrasimod (APD334) in Phase
2 evaluation for multiple autoimmune indications, and APD371 in
Phase 2 evaluation for the treatment of pain associated with
Crohn's disease. In addition, Arena has collaborations with the
following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc.
(commercial stage), Axovant Sciences (Phase 2 candidate), and
Boehringer Ingelheim International GmbH (preclinical
candidate).
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 "expected," "intended,"
"look forward to," "believe," "potential," "become," "believed to,"
"may," "can," "focused on," "designed to," 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 about the ongoing Phase 2
program for etrasimod; the ability to complete planned trials of
etrasimod; the expected timing of clinical data; the potential of
etrasimod, including to improve treatment of UC patients, to
deliver clinical utility across a range of autoimmune conditions
and to become a disease modifying therapy; the potential of Arena's
drugs and drug candidates; and Arena's focus, 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 the following: enrolling
patients in our ongoing and intended clinical trials is competitive
and challenging; clinical trials and other studies may not proceed
at the time or in the manner expected or at all; results of
clinical trials and other studies are subject to different
interpretations and may not be predictive of future results; the
timing and outcome of research, development and regulatory review
is uncertain; topline data may not accurately reflect the complete
results of a particular study or trial; 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; unexpected or
unfavorable new data; risks related to developing and
commercializing drugs; 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; the risk that
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; government and
third-party payor actions, including relating to reimbursement and
pricing; risks related to relying on collaborative arrangements;
the entry into or modification or termination of collaborative
arrangements; 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, including but not
limited to our Annual Report on Form 10-K which was filed on
March 15, 2017 and our Quarterly
Report on Form 10-Q which was filed on November 8, 2017. 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
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.