Pharmacopeia's First-in-Class Investigational Therapy PS433540 Achieves Statistically Significant Reductions in Blood Pressure in Hypertensiv...(r moderate in severity andincluded heada...),Health

Date:5/16/2008

r moderate in severity and included headaches and minor musculoskeletal and respiratory complaints. All of these events occurred with similar frequency in the three treatment groups. There was one case of peripheral edema in the placebo arm and one case of peripheral edema in one of the treated arms. There were no increases in liver enzymes above 2 times the upper limit of normal. On average, liver enzyme levels tended to decrease from baseline in the treated arms. There were no serious adverse events on PS433540 treatment. Three subjects discontinued therapy for adverse events, all of which were in the placebo group.

The leading, single-therapy antihypertensives across a broad range of classes, according to their labels, have the ability to lower seated office blood pressure up to 12/8mmHg.(1) Data show that a 2mmHg reduction in blood pressure decreases the average death rate from coronary heart disease by an estimated 4 percent and stroke by 6 percent.(2)

"These positive results indicate that PS433540 may be a unique new treatment option for physicians and patients," said Joel Neutel, M.D., Associate Professor of Medicine in the Department of Medicine at the University of California in Irvine, and Medical Director of Clinical Pharmacology at the Orange County Research Center in Tustin, CA, who was the lead investigator of the Phase 2a study. "The magnitude of the blood pressure reductions we saw in this study were very impressive, and we look forward to further evaluating the benefits of this novel compound."

An estimated 73 million Americans suffer from high blood pressure, a major risk factor for cardiovascular events and heart disease.(3) More than half of people diagnosed and treated with high blood pressure never reach suggested treatment goals and those who do often require two or more medications.(4) PS433540 is the first and only compound specifically designed to incorporate two proven mechanisms -- endothelin (ETA) and angiotensin (AT
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