EDSMB supports continuation of Arena's BLOOM study

US biopharmaceutical company Arena Pharmaceuticals says that an independent echocardiographic data safety monitoring board has recommended that a Phase III study of lorcaserin HCl in obesity should continue as planned. The board's findings were based on a review of unblinded echocardiograms performed after patients had completed six months of dosing.

The BLOOM study is a double-blind, randomized placebo-controlled assessment of a 20mg daily dose of lorcaserin HCl in the treatment of obese and overweight patients. Its primary efficacy goal is defined as a 5% or greater reduction in weight after 52 weeks, in comparison with placebo.

The EDSMB found that the rate of Food and Drug Administration-defined valvulopathy, in both the drug-treated and placebo groups, did not meet the predetermined stopping criteria. A similar review of 12-month data is scheduled for early next year. Arena welcomed the news and said that it is currently in talks with the FDA to finalize the protocols for two further Phase III studies that it intends to initiate in the next few months.