Arena's ADP356 produces weight loss in phase 2a study

By Angela McDaniels

Seattle, Dec. 13 - Arena Pharmaceuticals Inc. said patients who received APD356 as part of a phase 2b clinical trial for the treatment of obesity lost an average of 5.9 pounds over 12 weeks.

There was a highly statistically significant average weight loss of 4.0, 5.7 and 7.9 pounds at daily doses of 10 mg, 15 mg and 20 mg (10 mg dosed twice daily), respectively, in patients taking APD356 compared to 0.7 pounds for the placebo group.

APD356 was generally well tolerated at all doses investigated in the trial and there were no apparent effects on heart valves or pulmonary artery pressures, the company said.

"The results of this trial are extremely encouraging and unambiguously support further study of APD356. This trial demonstrated excellent weight loss, particularly considering there was no diet or exercise component in this trial, and the emerging safety and tolerability profile compares favorably

with other weight loss drugs," lead investigator Steven Smith of the Pennington Biomedical Research Center said in a company news release.

The phase 2b clinical trial was a randomized, double-blinded, dose-ranging study conducted at 40 sites in the United States. The trial enrolled 469 obese patients with a body mass index of between 29 and 46.

Patients were randomized into four groups to evaluate the safety and efficacy of daily 10 mg, 15 mg and 20 mg (10 mg dosed twice daily) doses of APD356 compared to placebo.

In addition to standard safety evaluations, patients were assessed by echocardiogram prior to enrollment and at the end of the treatment period. Patients did not receive any diet or exercise advice, but were required to abstain from consuming alcohol during the study, the company said.

Patient demographic characteristics at baseline were well balanced across the treatment groups, the company said.. Eighty-seven percent of participants were women, 53% were Caucasian, 29% were African-American and 18% were Hispanic. At baseline, the average age was 41.5 years, the average weight was 220 pounds and the average body mass index was 36.4.

Obesity affects tens of millions of adults and children in the Untied States and obesity-related medical costs were more than $117 billion in 2000, the company said.

APD356 is a orally administered, selective agonist of 5-HT2C serotonin receptors, which are located in the hypothalamus, an area of the brain that plays an important role in regulating food intake and metabolism, the company said.

Arena has issued patents in the United States and Europe covering 5-HT2C modulators.

Arena is a clinical-stage biopharmaceutical company based in San Diego that develops small molecule drugs for metabolic, cardiovascular, inflammatory and central nervous system diseases.

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