Phase 2b Trial to Examine Safety and Efficacy of DARA versus Active Control
PRINCETON, N.J., March 3 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq: PCOP), 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.
Pharmacopeia is a clinical development stage biopharmaceutical company dedicated to discovering and developing novel small molecule therapeutics to address significant medical needs. The company has a broad portfolio of clinical and preclinical candidates under development internally or by partners including seven clinical compounds in Phase 2 or Phase 1 development addressing multiple indications including hypertension, diabetic nephropathy, muscle wasting, inflammation and respiratory disease. The company is leveraging its fully integrated drug discovery platform to sustain the growth of its development pipeline. Pharmacopeia has established strategic agreements with major pharmaceutical and biotechnology companies, including Bristol-Myers Squibb, Celgene, Cephalon, GlaxoSmithKline, Organon, Schering-Plough, and Wyeth Pharmaceuticals. For more information please visit the company's website at http://www.pharmacopeia.com.
This press release, and oral statements made with respect to information contained in this press release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, goal, contingency or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward- looking statements include, but are not limited to, statements about the successful implementation of Pharmacopeia's strategic plans, Pharmacopeia's plans to develop PS433540, a product candidate from its DARA program, Pharmacopeia's Phase 2 and Phase 1 clinical studies with respect to PS433540, including timing and expected outcomes of such studies, Pharmacopeia's plans to develop PS178990, a product candidate from its SARM program, Pharmacopeia's Phase 1 clinical studies with respect to PS178990, including timing and expected outcomes of such studies, Pharmacopeia's plans to develop PS031291, a product candidate from its chemokine receptor CCR1 program, Pharmacopeia's estimates of the market opportunities for its product candidates, including PS433540, PS178990 and PS031291, Pharmacopeia's ability to successfully perform under its collaborations with Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Schering-Plough and Wyeth, Pharmacopeia's ability to build its pipeline of novel drug candidates through its own internally-funded drug discovery programs, third party collaborations and in-licensing, Pharmacopeia's ability to raise additional capital, Pharmacopeia's expectations concerning the development priorities of its collaborators, their ability to successfully develop compounds and its receipt of milestones and royalties from the collaborations, Pharmacopeia's anticipated operating results, financial condition, liquidity and capital resources, Pharmacopeia's expectations concerning the legal protections afforded by U.S. and international patent law, Pharmacopeia's ability to pursue the development of new compounds and other business matters without infringing the patent rights of others, additional competition, and changes in economic conditions.
Further information about these and other relevant risks and
uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and
10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia
urges you to carefully review and consider the disclosures found in its
filings which are available in the SEC EDGAR database at http://www.sec.gov
and from Pharmacopeia at http://www.pharmacopeia.com. All forward-looking
statements in this press release and oral statements made with respect to
information contained in this press release are qualified entirely by the
cautionary statements included in this press release and such filings.
These risks and uncertainties could cause actual results to differ
materially from results expressed or implied by such forward-looking
statements. These forward-looking statements speak only as of the date of
this press release. Pharmacopeia undertakes no obligation to (and expressly
disclaims any such obligation to) publicly update or revise the statements
made herein or the risk factors that may relate thereto whether as a result
of new information, future events, or otherwise.
Amy P. Sharpless
Corporate Communications Coordinator
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