ORLANDO, Fla., June 26, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today reported pooled Week 52 data from more than 6,000 patients in lorcaserin's pivotal Phase 3 clinical trial program that demonstrate lorcaserin 10 mg dosed twice daily reduced body weight in all patient subgroups evaluated, as defined by gender, age, ethnicity and starting body weight and Body Mass Index (BMI). Greater improvements in cardiovascular risk factors were also achieved with lorcaserin treatment compared to placebo overall and in most subgroups.
The pooled data show that more than twice as many lorcaserin patients (47.1%) achieved at least 5% body weight loss compared to placebo (22.6%) using Intent-to-Treat with Last Observation Carried Forward analysis. Patients in both the lorcaserin and placebo groups who decreased their body weight by at least 5% achieved more favorable changes in lipid parameters, glycemic parameters, blood pressure and high sensitivity C-reactive protein as compared to those who had less than 5% weight loss. Greater improvements in these cardiovascular risk factors were also achieved by patients who entered the studies with values indicative of elevated risk.
William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer, stated, "In our pivotal program, patients who achieved at least 5% weight loss benefited from greater improvements in cardiovascular risk factors, and the proportion of lorcaserin patients that achieved this amount of weight loss was double the placebo rate."
The data show that patients who took lorcaserin achieved greater reductions in body weight than the placebo group in all subgroups evaluated. Lorcaserin patients achieved greater improvements in total cholesterol, triglycerides, HDL cholesterol and insulin resistance compared to placebo across all subgroups. Greater improvements were also seen in fasting insulin, fasting glucose and blood pressure for lorcaserin patients compared to placebo overall and in most subgroups. Blood pressure did not increase in any evaluated subgroup.
Christen M. Anderson, M.D., Ph.D., Arena's Vice President of Clinical Development, stated, "The pooled Phase 3 data show that lorcaserin successfully treated a diverse population of adult women and men who needed to lose weight. Lorcaserin's effect on weight loss also led to improvements in cardiovascular risk factors in all subgroups evaluated."
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.
Phase 3 Program Overview
The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin was well tolerated and produced statistically significant weight loss. These double-blind, randomized, placebo-controlled trials evaluated obese patients, 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, such as hypertension, cardiovascular diseases or glucose intolerance.
In addition to the pivotal program, Arena is evaluating lorcaserin for weight management in obese and overweight patients with type 2 diabetes in its BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. Results of BLOOM-DM are expected late this year, and Arena plans to file the results as a supplement to the New Drug Application (NDA).
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss, and has completed a pivotal Phase 3 clinical trial program. Arena has filed an NDA for lorcaserin with the FDA, and the FDA has assigned a PDUFA date of October 22, 2010, for the review of the application.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.
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 advancement, therapeutic indication and use, safety, efficacy, tolerability, regulatory review and potential of lorcaserin; the BLOOM-DM trial, including the results of such trial; lorcaserin's patent coverage; and Arena's focus, goals, strategy, research and development 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, regulatory authorities or advisors may not find data from Arena's clinical trials and other studies sufficient for regulatory approval; the timing and ability of Arena to receive regulatory approval for its drug candidates; the timing, success and cost of Arena's lorcaserin program and other of its research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner Arena or others expect or at all; Arena's ability to enter into agreements to develop or commercialize its compounds or programs; Arena's ability to commercialize lorcaserin with a pharmaceutical company or independently; Arena's ability to obtain adequate funds; 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.
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SOURCE Arena Pharmaceuticals, Inc.