Arena: six-month analysis of phase 3 lorcaserin trial will determine feasibility of more studies

By Jennifer Lanning Drey

Eugene, Ore., Sept. 21 - Arena Pharmaceuticals, Inc. said a safety data analysis of its first phase 3 clinical trial of lorcaserin hydrochloride will determine whether the company moves ahead with two additional trials of the drug.

A data safety monitoring board is scheduled to review the data after six months of patient dosing, Dominic Behan, co-founder and chief scientific officer of the company, said Thursday at the Oppenheimer diabetes conference.

Arena announced the first patient dosing in the 3,000-patient, two-year trial on Sept. 12. The trial is studying lorcaserin as a treatment for obesity.

Assuming the safety board finds the data from the first phase 3 clinical trial to be positive, the company will begin two additional one-year phase 3 clinical trials at that time. One of the trials will test the drug in patients with diabetes, Behan said.

In total, the three studies will enroll about 6,000 patients.

Arena expects to file a New Drug Application for lorcaserin with the Food and Drug Administration in 2009 and have the drug on the market in 2010.

Lorcaserin is an orally administered compound that is selective in stimulating the 5-HT2C serotonin receptor, located in the hypothalamus, which helps regulate satiety and influences metabolic rate.

Arena is a San Diego-based clinical-stage biopharmaceutical company focusing on metabolic, central nervous system, cardiovascular and inflammatory diseases.

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