Patients with FDA-defined Valvulopathy Permitted to Enroll in 2nd and 3rd
Pivotal Trials - Echocardiogram Screening Requirement Eliminated
SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced the initiation of patient screening in the second and third Phase 3 pivotal trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for weight management in overweight and obese patients. Known as BLOSSOM (Behavioral modification and Lorcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), these one-year, double-blind, randomized and placebo-controlled trials are expected to collectively enroll approximately 3,750 overweight and obese patients. Consistent with Arena's proposal, the Food and Drug Administration, or FDA, is allowing patients with FDA-defined valvulopathy to enroll in both BLOSSOM and BLOOM-DM. This is different from the design of the initial lorcaserin pivotal study known as BLOOM, in which echocardiography was used to screen for patients with FDA-defined valvulopathy and exclude those patients from enrolling in the trial. Instead, in BLOSSOM and BLOOM-DM, there are no such echocardiographically defined exclusion criteria, although serial echocardiograms will be obtained to extend the lorcaserin safety database. BLOOM, BLOSSOM and BLOOM-DM comprise the entire planned pivotal trial program for lorcaserin.
"Eliminating the requirement of screening echoes, and receiving permission from the FDA to expand the patient population of the lorcaserin pivotal trial program to include patients with FDA-defined valvulopathy, is a significant and positive variation in the protocol for the second two pivotal trials," commented Steven R. Smith, M.D., principal investigator in the study and Professor at the Pennington Biomedical Research Center. "This change will allow the pivotal trial program to more fully explore, and develop a more complete understanding of, lorcaserin's selective mechanism and its safety profile."
"Given the prevalence and impact of obesity, patients and their physicians need new treatment options," commented Lee M. Kaplan, M.D., Ph.D., an investigator in the BLOOM, BLOOM-DM and BLOSSOM pivotal trials, Director of the Massachusetts General Hospital Weight Center and Associate Professor of Medicine at Harvard Medical School. "Including a broader representation of overweight patients and patients with obesity as part of the pivotal trial program for lorcaserin, including individuals with more significant valvulopathy and type 2 diabetes, is important for providing a more complete assessment of the safety and efficacy of this agent," concluded Dr. Kaplan.
The BLOSSOM trial will evaluate 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 (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to 29.9) with at least one co-morbid condition at about 100 sites in the United States. The BLOOM-DM trial will evaluate 10 mg and 20 mg daily doses of lorcaserin versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes mellitus at about 45 sites in the United States.
Consistent with the BLOOM trial, diet and exercise will also be included in the BLOSSOM and BLOOM-DM trials in accordance with current FDA guidelines, and the proportion of patients with a 5% or greater weight reduction from baseline at week 52 will be the primary efficacy endpoint. Secondary endpoints include changes in serum lipids and HbA1c and, in the BLOOM-DM trial, other indicators of glycemic control will also be evaluated. In both of these additional studies, 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 ongoing BLOOM trial, however, there will be no independent monitoring by an Echocardiographic Safety Monitoring Board. The complete lorcaserin Phase 3 pivotal program is planned to enroll a total of approximately 7,000 patients in these three trials. In addition to the planned pivotal trial program, several additional small studies, such as drug interaction and abuse potential studies, will be conducted.
"As we continue advancing our lorcaserin clinical program, we are looking forward to March 2008 when we expect the BLOOM Echocardiographic Safety Monitoring Board's review of echocardiograms for patients completing 12 months of treatment. We will continue to work with the FDA as we implement the final non-pivotal trial elements of the complete Phase 3 program," stated William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer.
An earlier estimate of the total external clinical costs of the Phase 3 trial program was updated from approximately $125 million to approximately $160 million. The increased estimate is primarily due to the increased number of patients Arena plans to enroll, and to Arena's initiative to expand the echocardiographic monitoring program by including patients with FDA-defined valvulopathy in the BLOSSOM and BLOOM-DM trials.
Lorcaserin, Arena's internally discovered oral drug candidate for the treatment of obesity, is in an ongoing Phase 3 program. The compound stimulates the 5-HT2C serotonin receptor, located in the hypothalamus, an area of the brain associated with the control of satiety 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 and had no apparent effects on heart valves or pulmonary artery pressure. A scheduled review by an independent Echocardiographic Safety Monitoring Board of unblinded echocardiograms performed after patients completed six months of dosing in the BLOOM trial confirmed that differences, if any, in the rates of FDA-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet the board's predetermined stopping criteria.
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 were more than $123 billion 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(R) and Arena(R) 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 continuation of the Phase 3 program
and development of lorcaserin, the significance of the inclusion in the
BLOSSOM and BLOOM-DM trials of patients with FDA-defined valvulopathy and,
in the case of the BLOOM-DM trial, with type 2 diabetes, the significance
of the review of echocardiographic data, the timing of the
Echocardiographic Safety Monitoring Board's month 12 review of
echocardiographic data, the rate of valvulopathy in the BLOOM trial, the
number of patients in the Phase 3 lorcaserin clinical trials, the timing,
number, protocol, design, scope, cost and other aspects of the lorcaserin
trials and studies, the completeness and usefulness of the expected
database of lorcaserin data in exploring, evaluating and understanding
lorcaserin, the growth and impact of obesity, the need for new treatment
options to address obesity, the ability of lorcaserin to fulfill such need,
the ability of data to support the use of lorcaserin, the tolerability,
side effects, efficacy and the commercial and other potential of
lorcaserin, the breadth of Arena's pipeline, Arena's strategy, preclinical
and internal and partnered clinical programs, and about Arena's ability to
develop compounds and commercialize drugs and other statements that are not
historical facts. 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, Arena's planned clinical trials and
studies may not proceed at the time or in the manner Arena expects or at
all, the results of preclinical studies or clinical trials 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, and the timing and receipt of payments and fees, if
any, from Arena's collaborators. 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.
Contacts: Jack Lief Mary Claire Duch
President and CEO WeissComm Partners
David Walsey 212.301.7228
Director, Corporate Communications
Arena Pharmaceuticals, Inc.
858.453.7200, ext. 1682
|SOURCE Arena Pharmaceuticals, Inc.|
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