Pharmacopeia Initiates Second Phase 2 Hypertension Study with PS433540 (DARA)
Monday March 3, 7:30 am ET
Phase 2b Trial to Examine Safety and Efficacy of DARA versus Active Control
PRINCETON, N.J., March 3 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP - News), an innovator in the discovery and development of novel small molecule therapeutics, today announced the initiation of a Phase 2b clinical study of PS433540, the company's lead internal product candidate. This randomized, double-blind, placebo and active-controlled, parallel-group study is designed to evaluate the compound's safety and efficacy at three different doses in subjects with Stage 1 and Stage 2 hypertension.
After a lead-in period, the multi-center trial is expected to randomize approximately 375 subjects into five study arms receiving PS433540 (200 mg, 400 mg or 800 mg); irbesartan (300 mg), an angiotensin II receptor antagonist; or placebo. All doses will be administered once daily for 12 weeks. The trial's primary objective is to compare the change from baseline in mean seated systolic blood pressure for each dose of PS433540 with placebo. Additional study objectives include comparisons of changes in blood pressure for each dose of PS433540 with irbesartan.
"We are pleased with the DARA program's rapid progress. This is our second Phase 2 study of PS433540 in hypertensive patients to provide key indications of the compound's therapeutic potential," said Les Browne, Ph.D., President and Chief Executive Officer of Pharmacopeia. "We look forward to the completion of this study by the end of 2008 as well as the reporting of results from our on-going Phase 2a trial in the second quarter of 2008."
Pharmacopeia recently completed enrollment in its ongoing Phase 2a trial of PS433540 in patients with Stage 1 and Stage 2 hypertension. Results from that study are expected during the second quarter of 2008. In Phase 1, PS433540 has been shown to be safe and well tolerated at a range of doses. The Phase 1 data also demonstrated that PS433540 produced statistically significant dose dependent increases versus placebo in plasma-renin activity levels as well as reductions in systolic and diastolic blood pressure in non- hypertensive healthy subjects.
PS433540 is a dual-acting angiotensin (AII) and endothelin (ET1) receptor antagonist that is being developed as a potential treatment for hypertension and diabetic nephropathy. PS433540, the first and only DARA compound in development, possesses two clinically validated mechanisms of action in a single compound. There is considerable preclinical and initial clinical data suggesting that compared to either agent alone, simultaneously blocking the actions of both AII and ET1 may provide significantly improved treatment options for several cardiovascular diseases.
surf's up......crikey
