Pharmacopeia’s Phase IIa hypertension study meets end point

The Phase IIa study met its primary endpoint by showing a statistically significant reduction in mean 24-hour systolic ambulatory blood pressure over placebo. The study also showed statistically significant improvements over placebo in mean 24-hour diastolic ambulatory blood pressure as well as seated blood pressure.

In this double-blind, placebo-controlled study, patients treated with 200mg of PS433540 once daily experienced a 12/9mmHg drop in mean 24-hour systolic and diastolic blood pressure and those treated with 500mg experienced a 15/10mmHg drop in mean 24-hour systolic and diastolic blood pressure. These reductions were highly statistically significant compared to placebo (P<0.001). Mean seated office systolic and diastolic blood pressure, the typical blood pressure measure, was also evaluated, with observed blood pressure drops of 17/11mmHg with the 200mg dose and 17/10mmHg with the 500mg dose (P<0.001 versus placebo). Once-daily treatment with 200 or 500mg of PS433540 was well tolerated. PS433540 is being developed as a potential treatment for both hypertension and diabetic nephropathy and is a novel blood pressure product candidate that possesses two validated mechanisms of action in a single molecule.