• Arena Pharmaceuticals Inc., of San Diego, said preliminary results from a Phase II trial of APD125 demonstrated statistically significant improvements in measurements of sleep maintenance vs. placebo in patients with chronic insomnia. Improvements were achieved without any limiting next-day cognitive effects. The 173-patient, randomized, double-blind, placebo-controlled study showed improvement on several endpoints related to sleep maintenance, including wake after sleep onset, wake time during sleep, number of awakenings, number of arousals, total sleep time and latency to persistent sleep. Arena plans to initiate a Phase III program for the inverse agonist of the 5-HT2A serotonin receptor in 2008, and also is considering an additional Phase II study to evaluate the effects of APD125 on patients' subjective assessment of sleep.

• DOV Pharmaceutical Inc., of Somerset, N.J., reported additional Phase Ib results for DOV 21,947, its lead triple reuptake inhibitor for depression and obesity. A preliminary analysis demonstrated the product was safe and well tolerated, and produced a statistically significant reduction in plasma triglyceride levels. Further analyses, it said, demonstrated DOV 21,947 significantly reduced body weight and body mass index vs. placebo. DOV intends to initiate a Phase II study of DOV 21,947 for treating depression in the first quarter of 2008.

• Gilead Sciences Inc., of Foster City, Calif., said data from a Phase IIb study (DAR-201) of darusentan, an investigational treatment for resistant hypertension, were published in the October 2007 edition of the Journal of Clinical Hypertension. In the study, darusentan was evaluated as an add-on antihypertensive treatment in patients who had not achieved goal blood pressure while being treated with full doses of three or more antihypertensive medications. Darusentan significantly reduced placebo-corrected mean trough sitting systolic blood pressure from baseline by 11.5 mmHg (p=0.015) after 10 weeks of treatment. Gilead currently is conducting two follow-on, pivotal Phase III clinical trials in resistant hypertension.

• Labopharm Inc., of Laval, Quebec, said it completed patient enrollment in the North American Phase III trial of its once-daily formulation of the antidepressant trazodone (study 04ACL3-001). More than 400 patients with unipolar depressive disorder have been enrolled in the study. The product uses Labopharm's Contramid controlled-release technology. Results are expected early in the second quarter of 2008. Separately, Labopharm requested a meeting with the FDA regarding the new drug application for its once-daily formulation of tramadol, which was the subject of an approvable letter from the agency. Based on additional analysis, Labopharm said it believes that it has demonstrated appropriate efficacy and safety.

• Metabolex Inc., of Hayward, Calif., began a 180-patient Phase II trial of MBX-8025 in overweight or obese patients with high cholesterol and triglycerides to assess the drug's effect on dyslipidemia, insulin resistance and obesity. The randomized, double-blind trial will assess the potential of the drug alone and in combination with Lipitor. The primary endpoint is the reduction in Apo B-100 compared with placebo. Secondary endpoints include effects on LDL, HDL, triglycerides and body weight and composition. Metabolic parameters, including glucose and insulin levels, also will be assessed. MBX-8025 is believed to regulate fatty acid degradation, lipid storage/transport and insulin sensitivity.

• Orexigen Therapeutics Inc., of San Diego, reported positive results in two Phase I trials of its sustained-release formulation of naltrexone, a key component of the company's lead product candidate for obesity, Contrave, which is being studied in Phase III trials. Encouraging pharmacokinetic data were seen when the product was tested alone and in combination with bupropion SR.

• VaxInnate Corp., of Cranbury, N.J., began the first Phase I trial of its M2e universal influenza vaccine. The vaccine is designed to target the M2 ectodomain portion of the flu virus, which is inherent regardless of virus strain. The study is expected to provide information on safety and immunogenicity, as well as on VaxInnate's Toll-like receptor technology using flagellin, which is designed to help strengthen the body's immune response. The trial is scheduled to enroll 60 volunteers in a double-blind, dose-escalating study of two doses injected 28 days apart. Data from the study are expected in spring 2008.