Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of Novel Anti-Obesity Compound
Arena Pharmaceuticals, Inc. announced positive top-line results from its Phase 2 clinical trial of APD356, Arena's orally administered, internally discovered drug candidate for the treatment of obesity. Over the 28 day treatment period, there was a highly statistically significant (p=.0002) average weight loss of 2.9 pounds in patients taking the 15 mg dose of APD356 versus 0.7 pounds for the placebo group. APD356 was generally well tolerated at all doses investigated in the trial. APD356 is a selective agonist of 5-HT2C serotonin receptors, which are located in the hypothalamus, an area of the brain known to play an important role in regulating food intake and metabolism.
"The prevalence of obesity has increased substantially in recent years and has reached alarming rates. Obesity is a serious health risk and is associated with several conditions, including diabetes, stroke and heart disease. Patients and their physicians need novel methods to treat obesity," stated Steven Smith, M.D., Principal Investigator and Associate Professor of the Pennington Biomedical Research Center. "The results of this trial are very supportive of further study and provide hope that obese individuals could have a new therapeutic option in the future to help control their weight in an effective, safe and controlled manner."
This Phase 2 clinical trial of APD356 was a randomized, double-blinded, multiple-dose study examining 352 obese volunteers at 24 clinical sites in the United States. The trial was to enroll otherwise healthy male and female patients with a body mass index (BMI) of between 30 and 45. Patients were randomized into four groups to compare doses of 1, 5 and 15 mg of APD356 versus placebo. The trial evaluated safety and weight loss after oral administration of APD356 once daily for 28 days. The trial protocol provided that patients should maintain their normal diet and level of activity, but required that patients abstain from consuming alcohol. In addition to standard safety evaluations, patients were assessed by echocardiogram upon enrollment, and were scheduled for follow-up echocardiograms at 29 and 90 days after receiving their first dose.
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