Pharmacopeia drug boosts plasma-renin in Ph I trial

US drugmaker Pharmacopeia says that results from its Phase I multiple ascending-dose study of its lead internal product candidate, PS433540 (DARA) demonstrated statistically-significant, dose-dependent increases in plasma-renin activity levels, as well as reductions in systolic and diastolic blood pressure. These findings are in addition to previously reported initial results from the MAD trial that showed all doses of PS433540 to be safe and well-tolerated. This MAD study was designed to evaluate the 14-day safety and tolerability of 50mg, 100mg, 250mg, 500mg and 1,000mg doses of PS433540 in healthy volunteers.

The trial's positive plasma-renin activity and blood pressure findings provide preliminary insight into the potential of PS433540 to treat hypertension, the US drugmaker noted. Study investigators observed a dose-dependent increase in plasma-renin activity levels, which was more pronounced at day 15 than at day one. This observed increase in plasma-renin activity is indicative of PS433540's ability to block the angiotensin receptor, a key target in efforts to lower and control blood pressure in hypertensive patients, the firm stated. Furthermore, associated with the increase in plasma-renin activity levels was a decrease in both diastolic and systolic blood pressure of up to 15mmHg.