Arena preparing to begin phase 3 clinical trial of lorcaserin

By Jennifer Lanning Drey

Eugene, Ore., June 15 - Arena Pharmaceuticals, Inc. is working with the Food and Drug Administration to develop the final protocol design of a phase 3 clinical trial of lorcaserin, its obesity treatment candidate, said Jack Lief, president and chief executive officer of Arena, during a presentation made Thursday at the Needham & Co. Biotechnology and Medical Technology Conference.

The company expects to begin a phase 3 clinical trial in the second half of the year, and FDA guidelines require a two-year safety study, Lief said.

Arena announced on Monday that patients in phase 2b clinical trials of lorcaserin for obesity had demonstrated a statistically significant average weight loss.

"Clearly the drug caused weight loss in a very dose-dependent highly predictable fashion," said Lief.

Patients in the phase 3 clinical trials will receive either one 10 mg dose of lorcaserin each morning or two 10 mg doses of the drug per day, with one being administered in the morning and the other in the evening, Lief said.

Patients in the phase 2b study achieved a mean weight loss of 4.0, 5.7 and 7.9 pounds at daily doses of 10 mg, 15 mg and 20 mg, respectively, compared to 0.7 pounds for the placebo group.

"It's a big market. At any give time, there are millions of people that are trying to lose weight in this country as well as in other developed countries," Lief said Thursday.

The most common side effects experienced in the phase 2b clinical trial were headaches and nausea, but both symptoms typically stopped after the first day, Lief said.

Lorcaserin did not appear to have a negative effect on any of the patients' heart valves, he said.

Additional IND before yearend

Arena also plans to announce another Investigational New Drug candidate before the end of the year, Lief said Thursday.

The company is now set up to produce one new Investigational Drug Application annually, he added.

Arena also plans to begin phase 2 clinical trials of AD125, its drug candidate for chronic insomnia, before the end of the year.

The company will present results from the phase 1 clinical trials of AD125 at the Associated Professional Sleep Societies, LLC Sleep 2006 preliminary program on June 21.

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

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