WASHINGTON, Oct. 25, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. reported that data from the pivotal BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) Phase 3 trial demonstrate lorcaserin significantly increased excess weight loss, improved markers of cardiovascular risk and glycemic parameters, and was not associated with depression or suicidal ideation. Additional subgroup analyses showed that lorcaserin caused the greatest improvements in lipid profiles, glycemic parameters and other markers of cardiovascular risk in patients in the highest risk categories. The new data were presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society.
Specifically, the new data show that lorcaserin increased excess weight loss during Year 1 of the BLOOM trial. Lorcaserin patients who completed the trial according to protocol lost 31.0% of their excess weight compared to 12.0% for the placebo group. This measurement is based on a normal Body Mass Index, or BMI, of 25. In addition to the previously announced improvements in glycemic parameters, including fasting glucose, fasting insulin and HOMA-IR, lorcaserin patients also achieved highly significant improvements in HbA1C over one year of treatment (p<0.0001). The greatest improvements were observed in patients with abnormal baseline values.
In addition to the previously announced tolerability data, today’s presentation also reported that lorcaserin demonstrated no increase in depression or suicidal ideation compared to placebo. Depression and suicidal ideation were monitored prospectively using the Beck Depression Inventory-II (BDI-II) and by adverse event reporting. At Week 52, 18.0% of lorcaserin patients and 16.1% of placebo patients reported at least a five-point improvement from baseline in BDI-II. A smaller number of lorcaserin patients had increases in the BDI-II total score as compared to placebo. Adverse events related to depression and their total rates at Year 1 for patients who took lorcaserin or placebo, respectively, were 3.1% and 3.0%. In addition, cumulative incidence of suicidal ideation was prospectively evaluated by administration of the BDI-II Questionnaire and did not differ between the lorcaserin and placebo groups at each measurement through two years of treatment.
Previously announced BLOOM data demonstrate that lorcaserin helped patients achieve clinically meaningful weight loss and maintenance of weight loss over two years of treatment. In the per protocol population, nearly two-thirds (66.4%) of lorcaserin patients lost at least 5% of their weight, compared to 32.1% of patients on placebo, and over one-third (36.2%) of lorcaserin patients lost at least 10% of their weight, compared to 13.6% for placebo. The average weight loss in this population was 17.9 pounds in the lorcaserin group, compared to 7.4 pounds in the placebo group. Using ITT-LOCF analysis, 67.9% of Year 1 lorcaserin responders maintained at least 5% weight loss during Year 2, compared to 50.3% for those patients re-randomized from lorcaserin treatment in Year 1 to placebo in Year 2.
Patient Disposition
BLOOM Trial Design
Phase 3 Program Overview
A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program’s hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Arena is also studying several key secondary endpoints, including changes in serum lipids, markers of inflammation and insulin resistance, and in the BLOOM-DM trial, other indicators of glycemic control.
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
The National Institutes of Health reported in 2007 that about 65% of US adults are overweight or obese. A 2009 publication in Health Affairs estimated the annual medical burden of obesity in the US to be $147 billion in 2008. Studies have shown that weight loss of 5% to 10% is medically significant and results in meaningful improvements in cardiovascular risk factors and a significant reduction in the incidence of type 2 diabetes in patients with glucose intolerance.
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 weight management. Arena has a broad pipeline of novel compounds targeting G protein-coupled receptors, an important class of validated drug targets, which includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Forward-Looking Statements
Arena Pharmaceuticals, Inc.
