12:00 AM
Apr 20, 2009
 |  BioCentury  |  Product Development

Weight and See

There are now three obesity compounds in late-stage development with positive Phase III data, which means the number of drugs available for the indication could double over the next few years. But at least some doctors believe that unless reimbursement practices change, it is unlikely that new drugs will be widely used.

Arena Pharmaceuticals Inc. recently released data from the Phase III BLOOM trial of lorcaserin, in which the serotonin (5-HT2C) receptor agonist met all three co-primary endpoints. Patients treated with lorcaserin achieved a mean weight loss at 1 year of 5.8% vs. 2.2% for placebo (p<0.001). The compound also showed a significant weight loss of ³5% in 48% of patients vs. 20% for placebo (p<0.001), and the proportion of patients in the lorcaserin arm who lost 10% or more of their body weight from baseline was significantly different from placebo (23% vs. 8%).

BLOOM was a two-year trial that measured the primary efficacy endpoints after the first year.

Lorcaserin met the benchmark laid out in FDA's draft guidance for obesity treatments published in 2007. The draft, which has not yet been made final, calls for one-year weight loss data showing either a 5% difference between the treatment and placebo groups, or for the treatment group to have twice the proportion of patients who lost at least 5% of body weight from baseline vs. placebo.

Lorcaserin also met BLOOM's secondary endpoints of significantly improving total cholesterol, LDL cholesterol, triglycerides and blood pressure vs. placebo.

According to President and CEO Jack Lief, if Phase III BLOSSOM data, expected in September, show weight loss similar to that in BLOOM, the company plans to submit an NDA by year end.

Lief believes doctors will prescribe lorcaserin based on its ability to reduce weight loss by at least 5% in 48% of patients, along with data that show lorcaserin is effective at maintaining weight loss for two years in patients who stay on the drug.

"In the real world, doctors will ask three questions: can I use the drug in a majority of my patients; will they remain on the drug to lose weight; and will they lose a clinically meaningful amount of weight? We can answer yes to all of these questions," Lief told BioCentury.

In BLOOM patients, he noted, "the vast majority lost some weight in a short period of...

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