Arena Pharmaceuticals' Lorcaserin for Obesity Passes Major Safety Milestone
SAN DIEGO, March 17 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc.
(Nasdaq: ARNA) announced today that following a planned review by an
independent Echocardiographic Data Safety Monitoring Board (EDSMB) it is
continuing BLOOM (Behavioral modification and Lorcaserin for Overweight and
Obesity Management), a pivotal trial evaluating the efficacy and safety of
lorcaserin hydrochloride for the treatment of obesity. The EDSMB's review of
unblinded echocardiographic data performed after patients completed 12 months
of dosing in the trial confirmed that differences, if any, in the rates of
Food and Drug Administration (FDA)-defined valvulopathy in patients treated
with lorcaserin and in the control group did not meet the EDSMB's
predetermined stopping criteria. Based on the EDSMB's review of the rate of
FDA-defined valvulopathy, Arena has been able to confirm that the statistical
power calculations used in the design of the Phase 3 trial program to monitor
patients for increased risk of developing valvulopathy are justified. The
findings from the month-12 review build on the EDSMB's September 2007 review
that evaluated echocardiograms after 6 months of dosing.
"This critical milestone assessing month-12 echocardiographic data
strongly supports lorcaserin's cardiovascular safety profile. We believe that
this exposure duration, even under a conservative interpretation of the
literature, would have been sufficient to observe a fenfluramine like effect
on heart valves if present. BLOOM's primary echo endpoint is based on the
month-12 data," said Jack Lief, Arena's President and Chief Executive Officer.
"We are committed to continued efforts to develop a robust database for
submission to the FDA in our efforts to provide patients a novel, safe and
effective obesity treatment."
BLOOM, the first of three lorcaserin Phase 3 trials, is a double-blind,
randomized, placebo-controlled trial involving nearly 3,200 patients in
approximately 100 centers throughout the United States. The trial is
evaluating a 20 mg daily dose (10 mg dosed twice daily) of lorcaserin versus
placebo over a two-year treatment period in obese patients (Body Mass Index,
or BMI, 30 to 45) with or without co-morbid conditions and overweight patients
(BMI 27 to less than 30) with at least one co-morbid condition. The proportion
of patients with a 5% or greater weight reduction from baseline at week 52 is
the primary efficacy endpoint. Patients received echocardiograms at screening,
6 months and 12 months after initiating dosing in the trial, and will receive
follow-up echocardiograms at 18 and 24 months. There are no further planned
The BLOSSOM (Behavioral modification and LOrcaserin Second Study for
Obesity Management) trial is evaluating 10 mg and 20 mg daily doses (10 mg
dosed once or twice daily) of lorcaserin versus placebo over a one-year
treatment period in obese patients with or without co-morbid conditions and
overweight patients with at least one co-morbid condition at about 100 sites
in the United States.
The BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and
Obesity Management in Diabetes Mellitus) trial is evaluating 10 mg and 20 mg
daily doses (10 mg dosed once or twice daily) of lorcaserin versus placebo
over a one-year treatment period in obese and overweight patients with type 2
diabetes at about 45 sites in the United States.
As in the BLOOM trial, diet and exercise are also included in the BLOSSOM
and BLOOM-DM trials, and the primary efficacy endpoint is the proportion of
patients with a 5% or greater weight reduction from baseline at week 52. Arena
is also studying several key secondary endpoints, including changes in serum
lipids and HbA1c and, in the BLOOM-DM trial, other indicators of glycemic
In both of these additional trials, all patients will receive
echocardiograms at baseline, at month 6, and at the end of the study to assess
heart valve function over time. In contrast to the BLOOM trial, however, there
are no echocardiographic exclusion criteria and there is no monitoring by an
independent monitoring board. The lorcaserin Phase 3 pivotal program is
planned to enroll a total of approximately 7,000 patients.
"The month-12 review of the echocardiographic data significantly adds to
our confidence in lorcaserin's cardiovascular safety profile," said William R.
Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "BLOOM is
scheduled to complete about one year from now, and I'm looking forward to
additional data demonstrating the potential of this novel compound to address
weight loss in a highly targeted manner."
Lorcaserin, Arena's internally discovered oral drug candidate for the
treatment of obesity, is in an ongoing Phase 3 program. The compound is the
first in a new class of obesity drug candidates targeting the 5-HT2C serotonin
receptor, which is located in the hypothalamus, a key area of the brain
associated with regulation of food intake and metabolism. Results from Phase 2
studies demonstrated that treatment with lorcaserin produced highly
statistically significant, progressive and dose-dependent weight loss over a
12-week period. Lorcaserin was generally well tolerated at all doses in the
Phase 2 clinical trials and had no apparent effects on heart valves or
pulmonary artery pressure.
Obesity affects tens of millions of people in the United States and poses
a serious long-term threat to their health and welfare. The number of
overweight and obese people has substantially increased over the past several
decades. Approximately two-thirds of all adults in the United States are obese
or overweight, and medical and related costs of obesity are $123 billion per
year according to a 2005 report by the International Diabetes Federation.
Being obese or overweight is associated with increased risk of a number of
conditions, including heart disease, stroke, diabetes, cancer and
osteoarthritis. Medical treatment options for obese and overweight people
currently are limited.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on
discovering, developing and commercializing oral drugs in four major
therapeutic areas: cardiovascular, central nervous system, inflammatory and
metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being
investigated in a Phase 3 clinical trial program for the treatment of obesity.
Arena's broad pipeline of novel compounds targeting G protein-coupled
receptors, an important class of validated drug targets, includes compounds
being evaluated independently and with its partners, Merck & Co., Inc. and
Ortho-McNeil Pharmaceutical, Inc.
Arena Pharmaceuticals® and Arena® are registered service marks of the
company. "APD" is an abbreviation for Arena Pharmaceuticals Development.
Certain statements in this press release are forward-looking statements
that involve a number of risks and uncertainties. Such forward-looking
statements include statements about the significance of the review of
echocardiographic data; the continuation of the Phase 3 program and
development of lorcaserin; the sufficiency of the lorcaserin exposure duration
to observe a fenfluramine like effect on heart valves; Arena's development of
a lorcaserin database and the content and use of such database; Arena's
efforts to provide patients a novel, safe and effective obesity treatment; the
protocol, design, scope, enrollment, number, timing and other aspects of
clinical trials and other studies of lorcaserin and other of Arena's drug
candidates; the tolerability, side effects, safety profile, efficacy and the
commercial and other potential of lorcaserin and other of Arena's drug
candidates; the growth and impact of obesity; the advancement and content of
Arena's pipeline; and other statements about Arena's vision, outlook,
strategy, preclinical and internal and partnered clinical programs, and
ability to develop compounds and commercialize drugs. 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, clinical
trials and studies may not proceed at the time or in the manner Arena expects
or at all, the results of clinical trials or preclinical studies may not be
predictive of future results, Arena's ability to partner lorcaserin, APD125,
APD791 or other of its compounds or programs, the timing, success and cost of
Arena's research, out-licensing endeavors and clinical trials, Arena's ability
to obtain additional financing, Arena's ability to obtain and defend its
patents, the timing and receipt of payments and fees, if any, from Arena's
collaborators, and Arena's ability to redeem with common stock any outstanding
shares of its series B convertible preferred stock. 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. 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.
SOURCE Arena Pharmaceuticals, Inc.
CONTACT: Jack Lief, President and CEO or David Walsey, Director,
Corporate Communications, both of Arena Pharmaceuticals, Inc.,
+1-858-453-7200, ext. 1682; or Mary Claire Duch, Media Relations of WeissComm
Partners, +1-212-301-7228, for Arena Pharmaceuticals, Inc.