Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial

13-Sep-2007

Arena Pharmaceuticals, Inc. 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.

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 associated with the control of satiety and metabolism. 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. Lorcaserin was generally well tolerated at all doses and had no apparent effects on heart valves or pulmonary artery pressure.

https://www.bionity.com/en/news/69680/arena-pharmaceuticals-continues-phase-3-bloom-obesity-trial.html