PCOP), an innovator in the discovery and development of novel small
molecule therapeutics, announced that PS433540, its first-in-class
Dual Acting Receptor Antagonist (DARA), showed statistically significant
blood pressure reductions in a Phase 2a study in patients with mild to
moderate hypertension. PS433540 is being developed as a potential treatment
for both hypertension and diabetic nephropathy and is a novel blood
pressure product candidate that possesses two validated mechanisms of
action in a single molecule. The data will be presented today at the Recent
and Late Breaking Clinical Trials Session at the American Society of
Hypertension (ASH) Twenty-Third Annual Scientific Meeting and Exposition in
New Orleans.
The Phase 2a study met its primary endpoint by showing a statistically
significant reduction in mean 24-hour systolic ambulatory blood pressure
over placebo. The study also showed statistically significant improvements
over placebo in mean 24-hour diastolic ambulatory blood pressure as well as
seated blood pressure. In this double-blind, placebo-controlled study,
patients treated with 200 mg of PS433540 once daily experienced a 12/9mmHg
drop in mean 24-hour systolic and diastolic blood pressure and those
treated with 500 mg experienced a 15/10mmHg drop in mean 24-hour systolic
and diastolic blood pressure. These reductions were highly statistically
significant vs. placebo (P
"These positive results indicate that PS433540 may be a unique new
treatment option for physicians and patients," said Joel Neutel, M.D.,
Associate Professor of Medicine in the Department of Medicine at the
University of California in Irvine, and Medical Director of Clinical
Pharmacology at the Orange County Research Center in Tustin, CA, who was
the lead investigator of the Phase 2a study. "The magnitude of the blood
pressure reductions we saw in this study were very impressive, and we look
forward to further evaluating the benefits of this novel compound."
An estimated 73 million Americans suffer from high blood pressure, a
major risk factor for cardiovascular events and heart disease.(3) More than
half of people diagnosed and treated with high blood pressure never reach
suggested treatment goals and those who do often require two or more
medications.(4) PS433540 is the first and only compound specifically
designed to incorporate two proven mechanisms -- endothelin (ETA) and
angiotensin (AT1) receptor blockade -- in one molecule to treat high blood
pressure.
"We are very pleased with the results of this important Phase 2a trial
and look forward to future studies which will further assess the potential
of PS433540, perhaps even beyond blood pressure lowering," said Joseph A.
Mollica, Ph.D., Chairman of the Board and Interim President and Chief
Executive Officer of Pharmacopeia. "We believe PS433540's dual mechanism of
action may have a positive effect on diabetic kidney disease."
Patients with diabetes are at an increased risk for many complications,
including high blood pressure and diabetic kidney disease. Up to 73 percent
of patients with diabetes have been or are being treated for high blood
pressure,(5) and an estimated 20-30 percent of diabetic patients will
progress to diabetic kidney disease,(6) a devastating disease that may
require patients to undergo dialysis or a kidney transplant.(7)
Pharmacopeia recently initiated a 12-week, Phase 2b clinical trial with
PS433540 to evaluate the compound's safety and efficacy at three different
doses versus placebo in 375 subjects with Stage I and Stage II
hypertension. The study will also compare blood pressure reductions for
each dose with irbesartan. Pharmacopeia anticipates completion of the Phase
2b trial at the end of 2008.
About the Phase 2a study
In this prospective study, 234 men and women with Stage I and Stage II
hypertension entered into a single blind placebo run-in period for 3-4
weeks, after which 114 were randomized to receive double blind study
medication for four weeks. At the time of the database lock, 108 subjects
were available for evaluation, 93 of whom had both baseline and follow-up
ambulatory blood pressure measurements (placebo: 25; PS433540 200mg: 35;
PS433540 500mg: 33). The primary endpoint was the subjects' change from
baseline in mean 24-hour systolic ambulatory blood pressure after 4 weeks
of treatment. Additionally, investigators evaluated 24-hour diastolic
ambulatory blood pressure and mean seated office systolic and diastolic
blood pressure as well as a number of other endpoints.
About PS433540
PS433540 is the first and only blood pressure product candidate in a
new class of antihypertensives known as Dual Acting Receptor Antagonists
(DARAs). PS433540 is being developed as a potential treatment for
hypertension and diabetic nephropathy. PS433540 possesses two clinically
validated mechanisms of action in a single molecule. There is preclinical
and initial clinical data suggesting that compared to either mechanism
alone, simultaneously blocking angiotensin II and endothelin 1 at their
respective receptors, AT1 and ETA, may provide an improved treatment option
for several cardiovascular diseases. Because PS433540 is highly selective
for the AT1 and ETA receptors it is able to block the blood
pressure-raising actions of angiotensin and endothelin when they bind to
these receptors.
About Pharmacopeia
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 eight 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 alliances with major pharmaceutical and biotechnology
companies, including Bristol-Myers Squibb, Celgene, Cephalon,
GlaxoSmithKline, Schering-Plough, and Wyeth Pharmaceuticals. For more
information please visit the company's website at
pharmacopeia.
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 results of Pharmacopeia's Phase 2a clinical study
of PS433540, a product candidate from its DARA program, Pharmacopeia's
plans to develop PS433540, Pharmacopeia's other Phase 2 and Phase 1
clinical studies with respect to PS433540, including timing and expected
outcomes of such studies, Pharmacopeia's estimates of the market
opportunities for PS433540, the implementation of Pharmacopeia's strategic
plans, 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 other product candidates, including PS178990 and
PS031291, Pharmacopeia's ability to raise additional capital,
Pharmacopeia's anticipated operating results, financial condition,
liquidity and capital resources, 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 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
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 sec
and from Pharmacopeia at pharmacopeia. 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.
References
(1) Prescribing Information for Coreg CR(R), Lotensin(R), Avapro(R),
Benicar(R) and Norvasc(R)
(2) American Heart Association news release.
americanheart.mediaroom/index.php?s=43&item=59. Accessed
April 7, 2008.
(3) AHA 2007 Heart Disease and Stroke Statistics, p. 3.
(4) Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the
Joint National Committee on Prevention, Detection, valuation, and
Treatment of High Blood Pressure. Journal of the American Medical
Association. 2003;289:p.2560-2572.
(5) American Diabetes Association:
diabetes/utils/printthispage.jsp?PageID=STATISTICS_233192.
Accessed April 4, 2008.
(6) Diabetes Care, Volume 27, Supplement 1, January 2004.
(7) National Institute of Diabetes and Digestive and Kidney Diseases.
Pharmacopeia
pharmacopeia
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