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"Patient safety is and always has been a primary focus for Arena in oureffort to fully explore and understand lorcaserin's profile and its potentialto safely help a significant number of patients that are obese or overweightimprove their health by better managing their weight," said Jack Lief, Arena'sPresident and Chief Executive Officer. "The continuation of the trial is animportant milestone in that effort as we proceed with our extensive Phase 3development program, including two additional pivotal studies evaluatinglorcaserin's potential as a safe and effective treatment option for weightloss. We are also looking forward to additional support of lorcaserin'semerging safety profile through the upcoming month 12 EDSMB review in thefirst quarter of 2008."
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BLOOM is a double-blind, randomized, placebo-controlled trial involvingnearly 3,200 patients in approximately 100 centers in the United States. Thetrial is evaluating a 20 mg daily dose (10 mg dosed twice daily) of lorcaserinversus placebo over a two-year treatment period in obese patients (BMI 30 to45) with or without co-morbid conditions and overweight patients (BMI 27 to30) with at least one co-morbid condition. The primary efficacy endpoint isthe proportion of patients with a 5% or greater weight reduction from baselineat week 52 as compared to placebo. In an effort to perform a thorough safetyanalysis of the study, patients received echocardiograms at screening and 6months after initiating dosing in the trial, and will receive follow-upechocardiograms at 12, 18 and 24 months. As with the month 6 echocardiogramanalysis, the EDSMB will review the month 12 echocardiographic data and, basedupon predetermined criteria, will make a judgment as to whether it isappropriate to continue or stop the trial.
The complete lorcaserin program includes two Phase 3 pivotal trials inaddition to BLOOM that are scheduled to start later this year. Under theprotocols being finalized with the FDA, the two additional pivotal trials areexpected to evaluate daily doses of 20 mg and 10 mg versus placebo over aone-year treatment period, with one of the trials evaluating patients withtype 2 diabetes. Diet and exercise will be part of each of the pivotal trialsin accordance with FDA guidance. Also, Arena has proposed to the FDA tocontinue conducting patient echocardiograms in these additional pivotalstudies. Expanding the echocardiogram program beyond the BLOOM trial isprudent as part of the effort to establish a robust database to thoroughlyevaluate and understand lorcaserin's safety profile.
"There is a clear need for novel, safe and effective treatment options toaddress the grow
