Detailed results from a second pivotal trial of an experimental obesity drug, lorcaserin, show that it improves cardiovascular risk factors, according to Arena Pharmaceuticals.
The company reported in August that the 4,000-patient trial found that 47.2% of subjects taking lorcaserin, an oral drug, lost 5% or more of their weight after a year, compared with 25% of placebo patients.
At a meeting of the Obesity Society in Washington, Arena reported over the weekend similar secondary findings from its first pivotal trial of the drug.
Appetite signals blocked
Arena, along with rivals Vivus Inc and Orexigen Therapeutics Inc, is working to develop the first new prescription weight-loss drug in a decade.
Lorcaserin works in a way similar to fenfluramine, which was part of the fen-phen diet cocktail before it was withdrawn in 1997 after being linked to heart-valve damage.
Arena's drug is designed to block appetite signals in the brain, but by being much more selective than fenfluramine in the receptors it affects. Fenfluramine also binds to a separate cell receptor in the heart.
The company said lorcaserin was not associated with heart-valve problems.
Improved heart risk factors
Arena also said its trial found that lorcaserin helped improve patients' cardiovascular risk factors, including cholesterol and triglycerides, without increasing blood pressure or heart rate.
Measurements of quality of life, including physical function, self esteem, sexual life, public distress and work, improved in a dose-dependent fashion, the company said.
Looking only at patients who complied with treatment, about two-thirds met the 5% weight-loss threshold.
The results "are consistent with making this a first-line therapy for us," said Arena Chief Executive Jack Lief. He said the company is on schedule to file late this year for regulatory approval.
He also said there are "a lot of activity" surrounding discussions with potential partners for lorcaserin but declined to give any details.
"Lorcaserin is the only single agent (weight-loss drug) and this is what physicians want," Lief said.
The CEO said Arena has no plans to study lorcaserin in combination with other weight-loss drugs.
(Reuters Health, October 2009)
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