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"The weight loss results demonstrated by lorcaserin in the Phase 2bclinical trial, coupled with the compound's highly selective mechanism andgood tolerability, provide reason for optimism for the millions of Americansstruggling with the obesity epidemic," commented Steven R. Smith, M.D.,principal investigator in the study and Assistant Director for ClinicalResearch at the Pennington Biomedical Research Center. "As a clinician facedwith 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 hopefulthat lorcaserin will prove successful at addressing that need."
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"The data highlighted in this publication demonstrate lorcaserin'spotential 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 areconfident the three ongoing lorcaserin Phase 3 trials will build on theclinical data published today, and we eagerly anticipate the announcement ofour first Phase 3 data from the BLOOM trial around the end of March 2009. Weexpect the top-line BLOOM data will be followed by a peer reviewedpresentation of the data at a conference later in the year, the announcementof BLOSSOM data in the Fall, and the submission of our New Drug Application tothe FDA by the end of 2009."
A summary of results from this study were presented previously at the 2006American Diabetes Association Scientific Sessions.
Study Design
The Phase 2b clinical trial evaluated the efficacy and safety of threedoses of lorcaserin over a 12-week period in non-diabetic, obese patients. Thetrial was a randomized, double-blind, placebo-controlled study conducted atapproximately 40 sites in the United States. The trial enrolled 469 men andwomen with a Body Mass Index (BMI) ranging from 30 to 45. Patients wererandomized into four groups, receiving 10 mg once daily, 15 mg once daily, or10 mg twice daily of lorcaserin, or placebo. The primary efficacy endpoint wasa reduction in weight from baseline at the end of 12 weeks. There was norun-in period, and patients were counseled to maintain their usual diet andphysical activity. Patients received echocardiograms at screening and thecompletion of the study (day 85).
Study Results
Patients completing 12 weeks of treatment with lorcaserin achievedprogressive, dose-dependent and highly statistically significant weight lossof 4 pounds (1.8 kg), 5.7 pounds (2.6 kg) and 7.9 pounds (3.6 kg) at dailydoses of 10 mg, 15 mg and 20 mg (10 mg twice daily), respectively, compared toweight 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 carriedforward (ITT-LOCF) analysis. A statistically significant percentage oflorcaserin patients completing the study lost greater than or equal to 5% oftheir weight from baseline: 12.8%, 19.5% and 31.2% in the 10 mg, 15 mg and 20mg groups, respectively, compared to 2.3% of patients on placebo. The responserate to lorcaserin was high, with more than 90% of patients achieving somedegree of weight loss at the 20 mg dose.
Total cholesterol and waist circumference, both correlates ofcardiovascular risk, were significantly decreased by the two highestlorcaserin doses in this relatively short trial. Improvements in othersecondary endpoints were also achieved, including fasting blood sugar at the20 mg dose.
Lorcaserin was generally well tolerated at all doses in the study. Themost common side effects were mild to moderate and transient headache, nauseaand dizziness. Importantly, lorcaserin did not increase blood pressure orheart rate at any dose. Echocardiograms conducted at screening and completionof the study demonstrated no apparent drug-related effects on heart valves orpulmonary arterial pressure.
About Lorcaserin
Lorcaserin, Arena's internally discovered oral drug candidate for thetreatment of obesity, is in an ongoing Phase 3 program. The compound is thefirst in a new class of obesity drug candidates stimulating the 5-HT2Cserotonin receptor, which is located in the hypothalamus, an area of the brainassociated with regulation of food intake and metabolism.
About Obesity
Obesity affects tens of millions of people in the United States and posesa serious long-term threat to their health and welfare. The number ofoverweight and obese people has substantially increased over the past severaldecades. Approximately two-thirds of all adults in the United States are obeseor overweight, and medical and related costs of obesity are $123 billion peryear according to a 2005 report by the International Diabetes Federation.Being obese or overweight is associated with increased risk of a number ofconditions, including heart disease, stroke, diabetes, cancer andosteoarthritis. Medical treatment options for obese and overweight peoplecurrently are limited.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused ondiscovering, developing and commercializing oral drugs in four majortherapeutic areas: cardiovascular, central nervous system, inflammatory andmetabolic diseases. Arena's most advanced drug candidate, lorcaserin, is beinginvestigated 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 beingevaluated independently and with partners, including Merck & Co., Inc. andOrtho-McNeil Pharmaceutical, Inc.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of thecompany. "APD" is an abbreviation for Arena Pharmaceuticals Development.
Forward-Looking Statements
Certain statements in this press release are forward-looking statementsthat involve a number of risks and uncertainties. Such forward-lookingstatements include statements about the therapeutic indication, tolerability,side effects, efficacy and potential of lorcaserin; future results of clinicaltrials; future activities and announcements relating to lorcaserin, includingthe BLOOM results and the submission of an NDA for lorcaserin; and aboutArena's strategy, internal and partnered programs, and ability to developcompounds and commercialize drugs. For such statements, Arena claims theprotection of the Private Securities Litigation Reform Act of 1995. Actualevents or results may differ materially from Arena's expectations. Factorsthat could cause actual results to differ materially from the forward-lookingstatements include, but are not limited to, clinical trials and studies maynot proceed at the time or in the manner Arena expects or at all, the resultsof clinical trials or preclinical studies may not be predictive of futureresults, Arena's ability to receive regulatory approval for its drugcandidates, Arena's ability to partner lorcaserin, APD125, APD791 or other ofits compounds or programs, the timing, success and cost of Arena's research,out-licensing endeavors and clinical trials, Arena's ability to obtainadditional financing, Arena's ability to obtain and defend its patents and thetiming and receipt of payments and fees, if any, from Arena's collaborators.Additional factors that could cause actual results to differ materially fromthose stated or implied by Arena's forward-looking statements are disclosed inArena's filings with the Securities and Exchange Commission. Theseforward-looking statements represent Arena's judgment as of the time of thisrelease. Arena disclaims any intent or obligation to update theseforward-looking statements, other than as may be required under applicablelaw.Contacts: Jack Lief Mary Claire Duch President and CEO WeissComm Partners Media Relations David Walsey 212.301.7228 Director, Corporate Communications Arena Pharmaceuticals, Inc. 858.453.7200, ext. 1682
SOURCE Arena Pharmaceuticals, Inc.
