Pharmacopeia initiates Ph I PS433540 trial

Pharmacopeia, a specialist in the discovery and development of novel small-molecule therapeutics, has initiated a Phase IIa study of PS433540, its lead internal product candidate. The dual-acting angiotensin and endothelin receptor antagonist is being developed as a potential treatment for hypertension and diabetic nephropathy.

The objective of the Phase IIa randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the compound's safety and efficacy in subjects with Stage I and Stage II hypertension. This multicenter trial is expected to enroll 170 subjects. After a lead-in period, patients will be randomized into three study arms - one placebo and two active cohorts of 200mg and 500mg. Following the four-week treatment period, investigators will evaluate the patients' change from baseline in mean 24-hour ambulatory systolic blood pressure; mean 24-hour ambulatory diastolic blood pressure; and mean seated systolic and diastolic blood pressure.