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Pharmacopeia's First-in-Class Investigational Therapy PS433540 Achieves Statistically Significant Reductions in Blood Pressure in Hypertensive Patients
Date:5/16/2008

1) receptor blockade -- in one molecule to treat high blood pressure.

"We are very pleased with the results of this important Phase 2a trial and look forward to future studies which will further assess the potential of PS433540, perhaps even beyond blood pressure lowering," said Joseph A. Mollica, Ph.D., Chairman of the Board and Interim President and Chief Executive Officer of Pharmacopeia. "We believe PS433540's dual mechanism of action may have a positive effect on diabetic kidney disease."

Patients with diabetes are at an increased risk for many complications, including high blood pressure and diabetic kidney disease. Up to 73 percent of patients with diabetes have been or are being treated for high blood pressure,(5) and an estimated 20-30 percent of diabetic patients will progress to diabetic kidney disease,(6) a devastating disease that may require patients to undergo dialysis or a kidney transplant.(7)

Pharmacopeia recently initiated a 12-week, Phase 2b clinical trial with PS433540 to evaluate the compound's safety and efficacy at three different doses versus placebo in 375 subjects with Stage I and Stage II hypertension. The study will also compare blood pressure reductions for each dose with irbesartan. Pharmacopeia anticipates completion of the Phase 2b trial at the end of 2008.

About the Phase 2a study

In this prospective study, 234 men and women with Stage I and Stage II hypertension entered into a single blind placebo run-in period for 3-4 weeks, after which 114 were randomized to receive double blind study medication for four weeks. At the time of the database lock, 108 subjects were available for evaluation, 93 of whom had both baseline and follow-up ambulatory blood pressure measurements (placebo: 25; PS433540 200mg: 35; PS433540 500mg: 33). The primary endpoint was the subjects' change from baseline in mean 24-hour systolic ambulatory blood pressure after 4 weeks of treatment. Additionally, investigators evaluated
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SOURCE Pharmacopeia
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