Pharmacopeia completes recruitment in Ph IIa study

US small-molecule drugmaker Pharmacopeia has completed recruitment in a multicenter Phase IIa clinical study of PS433540 (DARA), its lead internal product candidate. The objective of the randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of 200mg and 500mg doses of PS433540 in subjects with Stage I and Stage II hypertension.

"We have made good progress advancing DARA's clinical development. Not only did we initiate this Phase IIa study approximately six months ahead of our original clinical development timeline, but we have now completed enrollment with the expectation of reporting results in the second quarter of 2008," said Les Browne, Pharmacopeia's chief executive. "As this is the first PS433540 study to include hypertensive patients, we are pleased to have the opportunity to demonstrate that DARA can effectively lower blood pressure in this patient population," he added.

Results from Phase I studies of the agent in normal subjects have indicated that it was well tolerated at all doses up to and including 1,000mg a day for 14 days, noted the firm, adding that several studies, including the multiple-ascending dose and angiotensin II challenge trials have shown that PS433540 appears to have a pharmacokinetic profile consistent with once-daily oral administration.