SAN DIEGO, Dec. 8 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. announced today publication of the Phase 2b clinical trial results of lorcaserin, its novel drug candidate for the treatment of obesity, in the December 4, 2008 issue of Obesity, the official peer reviewed journal of The Obesity Society. In this randomized, double-blind, placebo-controlled trial, patients treated with lorcaserin, as compared to placebo, experienced statistically significant greater weight loss, with a significantly greater proportion of patients losing at least 5% of their weight over a 12-week period. Weight changes of this magnitude have been shown to improve cardiovascular risk factors such as blood pressure and dyslipidemia, and to significantly reduce the risk of developing diabetes in patients with glucose intolerance. Improvements in other endpoints were also achieved, including decreases in cholesterol and waist circumference. Lorcaserin was well tolerated in all dose groups.
“The weight loss results demonstrated by lorcaserin in the Phase 2b clinical trial, coupled with the compound’s highly selective mechanism and good tolerability, provide reason for optimism for the millions of Americans struggling with the obesity epidemic,” commented Steven R. Smith, M.D., principal investigator in the study and Assistant Director for Clinical Research at the Pennington Biomedical Research Center. “As a clinician faced with the challenge of helping a growing number of patients safely lose weight, I am acutely aware of the need for novel treatment options and I am hopeful that lorcaserin will prove successful at addressing that need.”
“The data highlighted in this publication demonstrate lorcaserin’s potential to become the first in a new class of weight management agents, thereby addressing an urgent need for new approaches to the obesity epidemic,” said Jack Lief, Arena’s President and Chief Executive Officer. “We are confident the three ongoing lorcaserin Phase 3 trials will build on the clinical data published today, and we eagerly anticipate the announcement of our first Phase 3 data from the BLOOM trial around the end of March 2009. We expect the top-line BLOOM data will be followed by a peer reviewed presentation of the data at a conference later in the year, the announcement of BLOSSOM data in the Fall, and the submission of our New Drug Application to the FDA by the end of 2009.”
A summary of results from this study were presented previously at the 2006 American Diabetes Association Scientific Sessions.
Study Design
The Phase 2b clinical trial evaluated the efficacy and safety of three doses of lorcaserin over a 12-week period in non-diabetic, obese patients. The trial was a randomized, double-blind, placebo-controlled study conducted at approximately 40 sites in the United States. The trial enrolled 469 men and women with a Body Mass Index (BMI) ranging from 30 to 45. Patients were randomized into four groups, receiving 10 mg once daily, 15 mg once daily, or 10 mg twice daily of lorcaserin, or placebo. The primary efficacy endpoint was a reduction in weight from baseline at the end of 12 weeks. There was no run-in period, and patients were counseled to maintain their usual diet and physical activity. Patients received echocardiograms at screening and the completion of the study (day 85).
Study Results
Patients completing 12 weeks of treatment with lorcaserin achieved progressive, dose-dependent and highly statistically significant weight loss of 4 pounds (1.8 kg), 5.7 pounds (2.6 kg) and 7.9 pounds (3.6 kg) at daily doses of 10 mg, 15 mg and 20 mg (10 mg twice daily), respectively, compared to weight loss of 0.7 pounds (0.3 kg) for placebo (p<0.001 for each group). Similar results were observed by intent to treat, last observation carried forward (ITT-LOCF) analysis. A statistically significant percentage of lorcaserin patients completing the study lost greater than or equal to 5% of their weight from baseline: 12.8%, 19.5% and 31.2% in the 10 mg, 15 mg and 20 mg groups, respectively, compared to 2.3% of patients on placebo. The response rate to lorcaserin was high, with more than 90% of patients achieving some degree of weight loss at the 20 mg dose.
Total cholesterol and waist circumference, both correlates of cardiovascular risk, were significantly decreased by the two highest lorcaserin doses in this relatively short trial. Improvements in other secondary endpoints were also achieved, including fasting blood sugar at the 20 mg dose.
Lorcaserin was generally well tolerated at all doses in the study. The most common side effects were mild to moderate and transient headache, nausea and dizziness. Importantly, lorcaserin did not increase blood pressure or heart rate at any dose. Echocardiograms conducted at screening and completion of the study demonstrated no apparent drug-related effects on heart valves or pulmonary arterial pressure.
About Lorcaserin
Lorcaserin, Arena’s internally discovered oral drug candidate for the treatment of obesity, is in an ongoing Phase 3 program. The compound is the first in a new class of obesity drug candidates stimulating the 5-HT2C serotonin receptor, which is located in the hypothalamus, an area of the brain associated with regulation of food intake and metabolism.
About Obesity
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 are $123 billion per year 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 target G protein-coupled receptors, an important class of validated drug targets, and includes compounds being evaluated independently and with partners, including 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.
Forward-Looking Statements
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 therapeutic indication, tolerability, side effects, efficacy and potential of lorcaserin; future results of clinical trials; future activities and announcements relating to lorcaserin, including the BLOOM results and the submission of an NDA for lorcaserin; and about Arena’s strategy, internal and partnered 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, clinical trials and studies may not proceed at the time or in the manner Arena expects or at all, the results of clinical trials or preclinical studies may not be predictive of future results, Arena’s ability to receive regulatory approval for its drug candidates, 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.
CONTACT: Jack Lief, President and CEO, or David Walsey, Director,
Corporate Communications, both of Arena Pharmaceuticals, Inc.,
+1-858-453-7200, ext. 1682; or Mary Claire Duch, Media Relations of
WeissComm Partners, +1-212-301-7228, for Arena Pharmaceuticals, Inc.
Web site: http://www.arenapharm.com/
