Oct. 27, 2009 (PR Newswire) --

WASHINGTON, Oct. 27, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported today data from the pivotal BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) Phase 3 trial that demonstrate improvements in patients' body composition, cardiovascular risk factors and quality of life. These findings add to the previously announced top-line BLOSSOM data that showed highly significant weight loss with lorcaserin over one year of treatment in 4,008 patients.

The late-breaking data were presented by Lee Kaplan, M.D., Ph.D., Associate Professor of Medicine at Harvard Medical School and Director of the Massachusetts General Hospital Weight Center, at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society.

"Safety is of paramount importance in treating patients who are overweight or have obesity," said Dr. Kaplan. "We need new therapies that help patients reduce their weight and improve cardiovascular factors such as high blood pressure and cholesterol, while avoiding cardiac toxicity and symptoms of depression. Lorcaserin works by selectively affecting a unique and important pathway, which allows for significant weight loss and improvements in these important risk factors, along with an excellent safety and tolerability profile."

William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer, stated, "Treatment with lorcaserin offers patients the opportunity to achieve sustainable weight loss in a well-tolerated manner, resulting in improved cardiometabolic health and quality of life. In order to improve overall health, it's important to see these measurements moving in the right direction as patients reduce their weight. Based on lorcaserin's safety and efficacy profile, we expect primary care physicians to find lorcaserin an attractive first-line therapy for weight management."

Specifically, the new data demonstrate that treatment with lorcaserin over one year was associated with highly significant improvements or favorable trends compared to placebo in multiple secondary endpoints evaluated in the trial:

Body Composition

Using Intent-to-Treat Last Observation Carried Forward (ITT-LOCF) analysis, lorcaserin patients achieved highly significant improvements in Body Mass Index (BMI), waist circumference and hip circumference. Changes from baseline for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: BMI (kg/m squared), (-2.1, -1.7, -1.0); waist circumference (cm), (-6.2, -5.6, -4.2); and hip circumference (cm), (-5.3, -5.0, -3.3), (p<0.0001) compared to placebo for all measurements. In addition, lorcaserin patients lost significantly more body fat than the placebo patients.

Cardiovascular Risk Factors

Using ITT-LOCF analysis, lorcaserin helped improve patients' cardiovascular risk factors. Patients dosed with 10 mg of lorcaserin once or twice daily achieved statistical significance (p<0.05) versus placebo at Week 52 for percent change in HDL cholesterol and triglycerides and achieved favorable trends in total cholesterol and LDL cholesterol. Lorcaserin did not increase blood pressure or heart rate at any time point. Changes from baseline for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: diastolic blood pressure (mmHg), (-1.9, -1.0, -1.9); systolic blood pressure (mmHg), (-2.0, -1.1, -1.2); and heart rate (bpm), (-2.3, -1.1, -1.6).

Quality of Life

Lorcaserin did not increase depression or suicidal ideation compared to placebo. Adverse events related to depression and their rates for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: depression (1.9%, 1.1%, 1.8%); depressed mood (0.6%, 0.9%, 0.9%); and depressive symptoms (<0.1%, 0%, 0%).

Quality of Life, as assessed by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, improved to a significantly greater extent in the lorcaserin twice daily (p<0.0001) and lorcaserin once daily (p<0.01) groups as compared to placebo at Week 52. All measurements, including physical function, self esteem, sexual life, public distress and work, improved in a dose-dependent fashion.

"Our team at Arena has worked diligently to discover and develop a novel treatment for weight management that delivers the combination of efficacy, safety and tolerability. Lorcaserin patients in the pivotal program achieved meaningful weight loss and improvements in important secondary endpoints," said Jack Lief, Arena's President and Chief Executive Officer. "The Obesity Society meeting provides us with an outstanding opportunity to discuss lorcaserin's profile with the enthusiastic physicians who are in need of promising, new treatment options."

Safety and Tolerability Profile

Lorcaserin was very well tolerated.