Arena Pharmaceuticals Completes Enrollment with 3,182 Patients in Lorcaserin Phase 3 Trial for Obesity
SAN DIEGO, February 5, 2007 -- Arena Pharmaceuticals, Inc. today announced that it completed patient enrollment in the first of three planned Phase 3 pivotal trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for the treatment of obesity. Known as BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), this double-blinded, randomized, and placebo-controlled trial enrolled 3,182 patients at approximately 100 centers in the United States. Arena continues to expect BLOOM's independent Data Safety Monitoring Board (DSMB) to perform its month-six review of echocardiograms in the third quarter of 2007 and make a judgment as to whether it is appropriate to continue the trial.
"Completing the enrollment of more than 3,100 patients in the BLOOM trial in a little over four months reflects the significant need for additional options in the treatment of obesity," commented William Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "We are looking forward to the DSMB's review of the month-six echocardiographic data in the third quarter and the initiation of two additional one-year pivotal Phase 3 studies later this year."
The BLOOM trial is evaluating a 20 mg daily dose (10 mg dosed twice daily) of lorcaserin versus placebo over a two-year treatment period in obese patients (BMI 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to 30) with at least one co-morbid condition. The proportion of patients with a 5% or greater weight reduction from baseline at week 52 is the primary efficacy endpoint. All patients received echocardiograms at screening and will receive follow-up echocardiograms at 6, 12, 18 and 24 months after starting the trial. Echocardiograms will be reviewed by an independent DSMB at 6 and 12 months. The DSMB will review echocardiographic data, and based upon predetermined criteria will make a judgment as to whether it is appropriate to continue the trial at the time of each review.
The complete lorcaserin Phase 3 program is designed to enroll a total of approximately 6,000 overweight and obese patients in three pivotal trials. In addition to the BLOOM trial, two additional Phase 3 pivotal trials enrolling a total of approximately 3,000 patients will be initiated. In these additional pivotal trials Arena plans to evaluate the 20 mg and 10 mg daily doses versus placebo over a one-year treatment period, with one of the trials likely evaluating patients who also have type 2 diabetes. Diet and exercise will be part of each of the pivotal trials in accordance with the FDA guideline. In addition to the above planned pivotal trial program, several other small studies, such as drug interaction and abuse potential studies, will be conducted.
"Keeping the BLOOM trial on track is a top priority, and we are pleased to have completed enrollment of Arena's first Phase 3 clinical trial on schedule," commented Jack Lief, Arena's President and Chief Executive Officer.
Lorcaserin, Arena's orally administered, internally discovered drug candidate for the treatment of obesity, is in an ongoing Phase 3 program. The compound stimulates the 5-HT2C serotonin receptor, located in the hypothalamus, an area of the brain which helps regulate satiety and influences metabolic rate. Results from a Phase 2 study demonstrated that treatment with lorcaserin produced highly 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 realized a mean weight loss of 7.9 pounds, while patients on placebo lost less than one pound. Lorcaserin was generally well tolerated at all doses and had no apparent effects on heart valves or pulmonary artery pressure.
Obesity affects tens of millions of adults and children 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 were more than $117 billion in 2000. Being obese or overweight is associated with a number of conditions, including heart disease, stroke, diabetes, cancer and osteoarthritis. Medical treatment options for obese and overweight people are currently limited.
Source: Arena Pharmaceuticals, Inc.
Posted: February 2007
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