Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial

BLOOM Obesity Trial

Arena Pharmaceuticals announced that an independent Echocardiographic Data Safety Monitoring Board (the Board or EDSMB) found no reason to stop the ongoing pivotal Phase 3 trial, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management).

The BLOOM trial is evaluating the efficacy and safety of lorcaserin hydrochloride for the treatment of obesity. The findings of the Board were based on a planned detailed review of unblinded echocardiograms performed after patients completed six months of dosing in the trial. The review was conducted by the Board and confirms that differences, if any, in the rates of U.S. Food and Drug Administration (FDA)-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet predetermined stopping criteria.

The review also confirmed that the rate of FDA-defined valvulopathy in the placebo group is consistent with the company's statistical powering assumptions used in the design of the pivotal trial program to monitor patients for any increased risk of developing valvulopathy. Arena is currently in discussions with the FDA to finalize protocols for two additional Phase 3 pivotal trials scheduled to begin later this year.

"Patient safety is and always has been a primary focus for Arena in our effort to fully explore and understand lorcaserin's profile and its potential to safely help a significant number of patients that are obese or overweight improve their health by better managing their weight," said Jack Lief, Arena's President and Chief Executive Officer. "The continuation of the trial is an important milestone in that effort as we proceed with our extensive Phase 3 development program, including two additional pivotal studies evaluating lorcaserin's potential as a safe and effective treatment option for weight loss. We are also looking forward to additional support of lorcaserin's emerging safety profile through the upcoming month 12 EDSMB review in the first quarter of 2008."

BLOOM is a double-blind, randomized, placebo-controlled trial involving nearly 3,200 patients in approximately 100 centers in the United States. The 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 primary efficacy endpoint is the proportion of patients with a 5% or greater weight reduction from baseline at week 52 as compared to placebo. In an effort to perform a thorough safety analysis of the study, patients received echocardiograms at screening and 6 months after initiating dosing in the trial, and will receive follow-up echocardiograms at 12, 18 and 24 months. As with the month 6 echocardiogram analysis, the EDSMB will review the month 12 echocardiographic data and, based upon predetermined criteria, will make a judgment as to whether it is appropriate to continue or stop the trial.

The complete lorcaserin program includes two Phase 3 pivotal trials in addition to BLOOM that are scheduled to start later this year. Under the protocols being finalized with the FDA, the two additional pivotal trials are expected to evaluate daily doses of 20 mg and 10 mg versus placebo over a one-year treatment period, with one of the trials evaluating patients with type 2 diabetes. Diet and exercise will be part of each of the pivotal trials in accordance with FDA guidance. Also, Arena has proposed to the FDA to continue conducting patient echocardiograms in these additional pivotal studies. Expanding the echocardiogram program beyond the BLOOM trial is prudent as part of the effort to establish a robust database to thoroughly evaluate and understand lorcaserin's safety profile.

"There is a clear need for novel, safe and effective treatment options to address the growing problem of obesity, which poses a serious long-term threat to the health and welfare of tens of millions of people in the United States alone, including the majority of people with type 2 diabetes," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "This safety review of the lorcaserin echocardiographic data allows for continued development of this promising compound, which seeks to address weight loss by selectively stimulating a specific area of the brain associated with the control of satiety and metabolism. I am hopeful that future data will prove this approach to be the type of additional tool we need in the fight against obesity."