Meta-Analyses of Phase 3 Trials Show Obese and Overweight Patients Taking Arena Pharmaceuticals' Lorcaserin Achieved Statistically Significant Weight Loss
- Meta-Analyses of BLOOM, BLOSSOM and BLOOM-DM Trials Presented at ECO 2011, the 18th European Congress on Obesity -
ISTANBUL, May 26, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today presented meta-analyses of the three trials in the lorcaserin Phase 3 clinical trial program at ECO 2011, the 18th European Congress on Obesity. The analyses show that lorcaserin caused statistically significant weight loss compared to placebo at one year among 7,500 obese and overweight, diabetic and non-diabetic adults. The lorcaserin-mediated weight loss was associated with favorable changes in biomarkers that may be predictive of cardiovascular and metabolic risk and in quality of life.
Christen M. Anderson, M.D., Ph.D., Arena's Vice President, Lorcaserin Development, stated, "We are pleased to have the opportunity to share and discuss the results from the lorcaserin Phase 3 program with the European medical community at ECO, and we look forward to submitting a Marketing Authorization Application for regulatory approval of lorcaserin in Europe next year."
At one year, using Modified Intent-to-Treat with Last Observation Carried Forward analysis (MITT-LOCF) of the integrated results, 46.3% of lorcaserin 10 mg twice daily (BID) patients and 40.6% of lorcaserin 10 mg once daily (QD) patients achieved at least 5% weight loss, compared to 22.1% of patients on placebo, and 22.0% of lorcaserin 10 mg BID patients and 17.3% of lorcaserin 10 mg QD patients achieved at least 10% weight loss, compared to 8.3% of patients on placebo. Of the patients completing year one of the trials, 62.3% of lorcaserin 10 mg BID patients and 52.8% of lorcaserin 10 mg QD patients achieved at least 5% weight loss, compared to 32.0% of patients on placebo, and 33.5% of lorcaserin 10 mg BID patients and 25.5% of lorcaserin 10 mg QD patients achieved at least 10% weight loss, compared to 13.8% of patients on placebo. Notably, this meta-analysis included approximately 600 patients enrolled with type 2 diabetes, a disease that typically makes weight loss more difficult to achieve.
Changes in secondary endpoints of cardiovascular and metabolic risk were assessed in the Phase 3 program. Body Mass Index (BMI), waist circumference, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, systolic blood pressure, diastolic blood pressure, heart rate and quality of life were measured in all three trials in the Phase 3 program, and the integrated Year 1 results showed favorable statistically significant effects with lorcaserin 10 mg BID treatment compared to placebo. Lorcaserin did not increase heart rate or blood pressure; changes from baseline for patients who took lorcaserin 10 mg BID, lorcaserin 10 mg QD or placebo, respectively, were as follows: systolic blood pressure (mmHg), (-0.9, -0.2, -0.2); diastolic blood pressure (mmHg), (-1.4, -0.5, -0.8); and heart rate (bpm), (-1.0, -0.5, -0.2).
The most frequent lorcaserin-associated adverse events included headache, nausea, dizziness, fatigue and dry mouth. Headache was the only adverse event with an incidence that exceeded the placebo group by greater than 5%. In each trial, echocardiograms were performed at baseline and every six months to measure heart valve regurgitation. In the meta-analysis of the three trials, the proportion of patients who developed FDA-defined valvulopathy (moderate or greater mitral insufficiency and/or mild or greater aortic insufficiency) at Week 52 were as follows: lorcaserin 10 mg BID (2.37%), lorcaserin 10 mg QD (1.57%) and placebo (2.04%).
"There is a significant unmet need for effective treatment options that can help patients reduce their weight and improve their health in a well-tolerated manner," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "A diverse group of patients received lorcaserin in our Phase 3 program and achieved clinically meaningful weight loss and improvements in important cardiovascular and metabolic parameters."
The three lorcaserin Phase 3 trials randomized a total of 7,794 patients, and 7,500 patients were included in the primary efficacy analyses (MITT-LOCF), which required a patient to have taken at least one dose of study medication and have had at least one weight measurement subsequent to baseline. The MITT-LOCF analyses included 3,349 lorcaserin 10 mg BID patients, 865 lorcaserin 10 mg QD patients and 3,286 placebo patients. Patients had an average BMI, baseline weight and age of approximately 36 kg/m2, 100 kg and 45 years, respectively; approximately 80% of patients were female.
Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Arena submitted a New Drug Application (NDA) for lorcaserin to the US Food and Drug Administration (FDA) in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena is engaged in activities to address the issues raised by the FDA as part of its plan to submit a response to the CRL.
Lorcaserin Phase 3 Clinical Trial Program Overview
The lorcaserin Phase 3 clinical trial program consists of three double-blind, randomized, placebo-controlled trials, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), 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), and enrolled approximately 7,800 patients. BLOOM and BLOSSOM evaluated lorcaserin versus placebo in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition. BLOOM evaluated 3,182 patients over a two-year treatment period, and BLOSSOM evaluated 4,008 patients over a one-year treatment period. BLOOM-DM evaluated 604 obese and overweight patients with type 2 diabetes over a one-year treatment period. The trials included a standardized program of moderate diet and exercise guidance.
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. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the NDA for lorcaserin.
Arena Pharmaceuticals® and Arena® 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, mechanism of action and potential of lorcaserin; the significance of biomarkers; the submission of a Marketing Authorization Application for regulatory approval of lorcaserin; the response to the CRL for the lorcaserin NDA, including related plans and activities; the Eisai collaboration and potential activities thereunder; 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, the following: the timing of regulatory review and approval is uncertain; the risk that data and other information related to Arena's research and development programs, including for lorcaserin, may not meet safety or efficacy requirements or otherwise be sufficient for regulatory approval; Arena's response to the CRL for the lorcaserin NDA or submission of a Marketing Authorization Application for regulatory approval of lorcaserin may not be submitted when anticipated, if at all; the FDA may request other information prior to or after Arena submits such response or approval of the lorcaserin NDA; unexpected or unfavorable new data; risks related to commercializing new products; Arena's ability to obtain and defend its patents; the timing, success and cost of Arena's 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 expected or at all; Arena's ability to obtain adequate funds; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; and satisfactory resolution of pending and any future litigation or other disagreements with others. 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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Posted: May 2011