San Diego-based Arena Pharmaceuticals disappointed a lot of investors a couple months ago when its obesity drug didn’t help people shed as many pounds as hoped. But after combing through the data in greater detail, the company says it has evidence that its drug can help many patients lose weight, and that it leads to all sorts of other health benefits, like potentially lowering the risk of cardiovascular disease.
Arena (NASDAQ: ARNA) is presenting detailed results today from a clinical trial of 3,200 patients, known as Bloom, which compared its lorcaserin treatment to a placebo. The data being released today show that patients on the Arena drug for a year generally had lower blood pressure, lower cholesterol scores, improved blood sugar levels, and 30 percent lower levels of C-reactive protein in the blood—a marker for inflammation associated with higher risk of heart attacks.
The findings, which are being presented today at the American Diabetes Association annual meeting in New Orleans, could cause some investors to take another look at the prospects for lorcaserin, which was branded as a failure by many when the first hints of data were made public in March. The major finding of the study is that patients lost an average of 5.8 percent of their body weight on the drug, compared with 2.2 percent body weight loss in the placebo group. The FDA generally considers that a weight loss drug should be five percentage points better than a placebo—so on that score, Arena came up short.
Arena acknowledges that, but it’s trying to draw attention to a second FDA definition that gives the company reason for optimism that it will win approval for lorcaserin. If a drug helps twice as many patients lose 5 percent or 10 percent of their body weight compared to a placebo, that’s another valid definition for success, the FDA has said. On that count, Arena was a winner. About two-thirds of patients who stayed on the trial a full year lost 5 percent of their body weight, compared with one-third who did as well on a placebo. More than one-third of the patients on the drug lost 10 percent of their body weight, which was almost triple the rate among those on a placebo.
“This has an opportunity to be the drug of first choice,” says Arena CEO Jack Lief. “Our ability to tie all of these outcome measures together, with a well-tolerated drug, is something no one else has.”
Any drug that can help people lose significant amounts of weight with no serious side effects has a chance to be a big seller. Obesity rates in the U.S. have been skyrocketing for years, with about two-thirds of U.S. adults now considered overweight or obese, putting them at risk for a litany of other conditions like heart disease, diabetes, high blood pressure, and arthritis. The cost to society of all this unhealthy weight gain is hard to measure because it’s intertwined with so many diseases, but a U.S. Surgeon General’s report in 2000 indicates that obesity may be responsible for about 9 percent of national healthcare spending.
Arena has two primary competitors in the race to develop an effective new drug for this epidemic. One is San Diego-based … Next Page »
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