Arena Pharmaceuticals Initiates Lorcaserin Phase 3 Obesity Clinical Trial
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced the dose of the early accommodating within the first of three intentional Phase 3 clinical experimentation evaluate the efficacy and refuge of its organize remedy opponent, lorcaserin hydrochloride, in go to of the remedy of chubbiness. Known by means of BLOOM (Behavioral fastness and Lorcaserin for Overweight and Obesity Management), this double-blind, randomized, and placebo-controlled trial will consist of something like 100 centers in the United States and be anticipated to enroll curved about 3,000 overweight and obese patients. The percentage of patients beside a 5% or greater compensate slackening from baseline at week 52 is the former endpoint.
“Based subsequent to the until that circumstance announced Phase 2b facts demonstrating that treatment with lorcaserin resulted in statistically imperative, tolerant and dose-dependent weight death with a collectively favorable tolerability profile, we deem lorcaserin have the potential to be an stylish unsullied psychiatric relief for obesity,” aside William Shanahan, M.D., Arena’s Vice President and Chief Medical Officer. “As we enter a new phase the Phase 3 program, we be outward net flush out readdress to the DSMB’s appraisal of the six-month echocardiographic data sometime on all sides next summer as a significant safety milestone that will trigger the debut of new Phase 3 opinion poll.” The BLOOM trial will authority a 20 mg dose (10 mg dose twice over daily) of lorcaserin versus placebo over and done with a two-year treatment size in obese patients (BMI 30 to 45) with or lacking co-morbid provisions and overweight patients (BMI 27 to 30) with at lowest one co-morbid situation. All patients will receive echocardiograms at baseline and follow-on echocardiograms at 6, 12, 18 and 24 months after starting the trial. Echocardiograms will be review via an self-directed Data Safety Monitoring Board (DSMB) at 6 and 12 months. The DSMB will review echocardiographic data, and will make a drink as to whether or not it is grab to proceed with the trial at the time of all review.
The widespread lorcaserin Phase 3 program is designed to enroll a disbursement of approximately 6,000 patients in three pivotal trials. Assuming a jovial six-month safety balancing from the DSMB for the BLOOM trial, two additional Phase 3 trials enrol a total of approximately 3,000 patients will be initiate. In these additional pivotal trials Arena policy to evaluate the 20 mg and 10 mg day after day dose versus placebo over a one-year treatment period, with one of the trials evaluating patients with body of people 2 diabetes. Diet and exert will be division of each of the pivotal trials in accordance with the FDA guideline. In enhancement to the above planned pivotal trial program, several other mini studies, such as drug interchange and voiced abuse potential studies, will be conduct.
“The initiation of Arena’s first Phase 3 clinical program is a essence deed for the firm,” commented Jack Lief, Arena’s President and Chief Executive Officer. “Working with our committed group of clinical investigators, we are cheerful that we will know how to deal in a new and glum medical alternative for overweight and obese patients, who presently hold fixed treatment option.” About Lorcaserin Lorcaserin, Arena’s in words administered, internally discovered drug candidate for the treatment of obesity, is in an ongoing Phase 3 program. The multiple is selective in cool the 5-HT2C serotonin receptor, to be found in the hypothalamus, which help tweak satiety and wiles metabolic rate. Results from a Phase 2 study illustrate that treatment with lorcaserin produced distinctively statistically significant, progressive and dose-dependent weight loss over a 12-week period. In the study, which excluded diet and exercise, patients taking a daily 20 mg dose of lorcaserin accepted a denote weight loss of 7.9 squash, while patients on placebo mislaid smaller numeral than 1 pound. Lorcaserin be generally ably tolerate in any means of access doses and have no supposed effects on heart valve or pulmonary artery vasculature.
About Obesity Obesity affect tens of millions of adults and brood in the United States and pose a grave long-term peril to their robustness and welfare. The digit of overweight and obese society has substantially increased over the departed several decades. Approximately two-thirds of all adults in the United States are obese or overweight and medical and linked costs of obesity be over and done $117 billion in 2000. Being obese or overweight is associated with a quantity of conditions, plus heart virus, feel, diabetes, cancer and osteoarthritis. Medical treatment options for obese and overweight people are currently limited.
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Arena has four internally discovered, clinical-stage drug candidate for major diseases and mess. The supreme advanced, lorcaserin, is one do research in a Phase 3 clinical trial program for the treatment of obesity. Arena’s lead drug candidate for the treatment of jumpiness, APD125, a compound with a novel machinery of way of life to enhance nip a sleep concern, is expected to enter a Phase 2 clinical trial. Arena-discovered drug candidates are also being evaluate in two clinical-stage assistance with major pharmaceutical company: Merck & Co., Inc. and Ortho-McNeil, Inc., a Johnson & Johnson company.
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Forward-Looking Statements Certain confirmation here grasp relief are forward-looking statements that catch a number of risk and uncertainties. Such forward-looking statements include statements about the time, protocol, ornamentation, fringe and other aspect of the planned Phase 3 clinical trials and other studies of lorcaserin, the potential efficacy and tolerability of lorcaserin, the expected role and conduct yourself of the DSMB, the timing of DSMB review, and the expected step 2 clinical trial of APD125 and other statements that are not historical facts including statements precede by the libretto “may,” “will,” “plan,” “expect,” “hope” or correspondent words. For such statements, Arena claim the stuffing of the Private Securities Litigation Reform Act of 1995. Actual measures or grades may contrast materially from Arena’s expectations. Factors that could rationale actual results to differ materially from the forward-looking statements include, but are not limited to, Arena’s planned clinical trials and studies may not proceed at the time or in the attitude Arena foresee or at all; the results of preclinical studies or clinical trials may not be predictive of planned results; the timing, glory and assertion of Arena’s research and elevation; Arena’s capacity to partner lorcaserin, APD125 or other of its compounds or programs; Arena’s ability to pick responsive additional invest in; Arena’s ability to obtain and uphold its patent; and the timing and delivery of payments and fees, if any, from Arena’s collaborator. Additional factor that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are speak in confidence in Arena’s filings with the Securities and Exchange Commission. These forward-looking statements imply Arena’s judgment starting the time of this release. Arena disclaim any focussed or necessity to update these forward-looking statements, slab as may be sought after underneath applicable canon.
Arena Pharmaceuticals, Inc.
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