Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiographic Data Safety Monitoring Board Review

This is heartening.

"Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that an independent Echocardiographic Data Safety Monitoring Board (the Board or EDSMB) found no reason to stop the ongoing pivotal Phase 3 trial, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management). The BLOOM trial is evaluating the efficacy and safety of lorcaserin hydrochloride for the treatment of obesity. The findings of the Board were based on a planned detailed review of unblinded echocardiograms performed after patients completed six months of dosing in the trial. The review was conducted by the Board and confirms that differences, if any, in the rates of U.S. Food and Drug Administration (FDA)-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet predetermined stopping criteria. The review also confirmed that the rate of FDA-defined valvulopathy in the placebo group is consistent with the company's statistical powering assumptions used in the design of the pivotal trial program to monitor patients for any increased risk of developing valvulopathy. Arena is currently in discussions with the FDA to finalize protocols for two additional Phase 3 pivotal trials scheduled to begin later this year."

Whew. That's a mouthful.

In other words, this drug is worrisome enough that the hearts of those involved in the trial required evaluation and that the evaluation for valve disease did not show enough problems to stop the trial, i.e., not enough people died or got sick to stop it.

"'There is a clear need for novel, safe and effective treatment options to address the growing problem of obesity, which poses a serious long-term threat to the health and welfare of tens of millions of people in the United States alone, including the majority of people with type 2 diabetes,' said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer."

Hey, Dr. Shanahan, the safest and most effective treatment for obesity is called fewer Calories in than out. That will fulfill the need.

Have you ever heard of that approach?

Oh, I see, you cannot make a buck that way.

"'This safety review of the lorcaserin echocardiographic data allows for continued development of this promising compound, which seeks to address weight loss by selectively stimulating a specific area of the brain associated with the control of satiety and metabolism. I am hopeful that future data will prove this approach to be the type of additional tool we need in the fight against obesity.'"

So you are mucking around in the brain, eh?

Remember folks, these are the same people who cannot cure toenail fungus.