SAN DIEGO, July 25, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the first
subject has been dosed in the Phase 2 CAPTIVATE trial evaluating
olorinab, an investigational, oral, highly-selective, full agonist
of the cannabinoid type 2 receptor (CB2) in development
for the treatment of visceral pain associated with gastrointestinal
(GI) disorders. The trial will evaluate the efficacy and
safety of three dose levels of olorinab for 12-weeks in
approximately 240 subjects experiencing abdominal pain associated
with IBS, including IBS with constipation (IBS-C) or IBS with
diarrhea (IBS-D).
"I am thrilled that the first subject has enrolled in Arena's
CAPTIVATE trial, supporting the advancement of novel pain
management options within the digestive disease field," said
Lin Chang, MD, Professor of Medicine
at the Vatche and Tamar Manoukian Division of Digestive Diseases at
the University of California, Los
Angeles. "The majority of IBS patients describe their most
problematic symptom as frequent abdominal pain, which often
significantly impacts their quality of life. With limited
pain management options available for GI disorders, there is a
clear unmet medical need and an opportunity to improve the lives of
patients."
"The initiation of the CAPTIVATE clinical trial is a significant
milestone for Arena as we strategically expand our pipeline
portfolio, with the goal of validating the broad potential impact
of olorinab and ultimately delivering a novel option for chronic
pain relief to patients worldwide," stated Preston Klassen, MD, MHS, Executive Vice
President, Research and Development and Chief Medical Officer of
Arena. "We believe that olorinab has the potential to be a
first-in-class therapy to address the strong clinical need to
manage pain in patients with GI disorders, and we are committed to
advancing the program expeditiously."
About CAPTIVATE
CAPTIVATE is a Phase 2, multi-center,
randomized, double-blind, placebo-controlled, 12-week study of
olorinab in patients with irritable bowel syndrome (IBS),
experiencing abdominal pain. The study will evaluate change in
abdominal pain in patients with the clinical diagnosis of IBS with
predominant constipation (IBS-C) or diarrhea (IBS-D). The
primary objective of this trial is to assess the safety and
efficacy of olorinab administered three times daily (TID).
The primary endpoint is improvement in the weekly Average Abdominal
Pain Scale (AAPS) from baseline. The CAPTIVATE trial will
enroll approximately 240 patients and will be conducted in study
sites across the United
States.
About Olorinab
Olorinab (APD371) is an oral,
peripherally acting, highly-selective, full agonist of the
cannabinoid type 2 receptor (CB2). Olorinab is an
internally discovered investigational drug candidate that Arena is
exploring for development in several indications, with an initial
focus on visceral pain associated with gastrointestinal disorders.
This compound, through its selectivity for CB2, versus
cannabinoid type 1 receptor (CB1), is designed to
provide pain relief without psychoactive adverse effects.
Olorinab is an investigational compound that is not approved for
any use in any country.
About IBS
Irritable bowel syndrome (IBS) is a common
disorder of the gastrointestinal (GI) tract. Signs and symptoms
include cramping, abdominal pain, bloating, gas, and predominant
constipation (IBS-C) or diarrhea (IBS-D), or mixed (IBS-M). IBS is
a chronic condition that needs to be managed long term. There
are approximately 25 million patients in the United States with IBS, with approximately
80% reporting frequently recurring or continuous abdominal
pain.
About Arena Pharmaceuticals
Arena Pharmaceuticals is
driven to deliver novel, transformational medicines with optimized
pharmacology and pharmacokinetics to patients globally. Arena's
proprietary pipeline includes multiple potentially first- or
best-in-class assets with broad clinical utility.
Etrasimod (APD334), with potential utility in a broad range of
immune and inflammatory conditions, is being evaluated in
later-stage clinical programs in ulcerative colitis (UC) and
Crohn's disease (CD), as well as in programs for other indications
such as atopic dermatitis. Arena is also evaluating olorinab
(APD371) in a Phase 2 program for gastrointestinal pain. Arena
continues to assess other earlier research and development stage
drug candidates, including APD418 for decompensated heart
failure.
Arena has additional license agreements and partnerships,
including with United Therapeutics (ralinepag in a Phase 3 program
for pulmonary arterial hypertension), Everest Medicines Limited
(etrasimod in Greater China and
select Asian countries), Boehringer Ingelheim International GmbH
(undisclosed target – preclinical), Outpost Medicine, LLC
(undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai
Inc. (BELVIQ® – marketed product).
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
accompanied by words such as "potential," "believe," "will,"
"goal," "objective," "designed to," "driven to," "potentially,"
"being evaluated for," "evaluating", "assess," or words of similar
meaning, or they may be identified by the fact that they do not
relate strictly to historical or current facts. Such
forward-looking statements include, without limitation, statements
about the following: the opportunity, development and potential of
olorinab, including regarding its design, broad potential
impact, and ability to deliver pain relief, improve lives, and
satisfy an unmet medical or clinical need; the CAPTIVATE trial,
including trial enrollment and design; the significance of a
milestone; the expansion of our pipeline; Arena's drive, the
ability to expand of our pipeline, and commitment to advance
programs; and the potential of Arena's assets, programs, licenses,
and collaborations, including to be first- or best-in-class or have
broad clinical utility. 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 timing
and outcome of research, development and regulatory review is
uncertain; results of clinical trials and other studies are subject
to different interpretations and may not be predictive of future
results; 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; clinical trials and other studies may not proceed
at the time or in the manner expected or at all; enrolling patients
in our ongoing and intended clinical trials is competitive and
challenging; 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; risks related to
unexpected or unfavorable new data; risks related to developing and
commercializing drugs; risks related to relying on partners and
other third parties; 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 (SEC), including but
not limited to its most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q. 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, MD
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.