Positive Results from POZEN Phase 1 Study (?Co-Rx?) Presented At AHA
Study Showed a Spacing Strategy of PA32540 Apart from Clopidogrel Produces Superior Platelet Inhibition Compared to Standard of Care Dual Antiplatelet Therapy (DAPT) with Delayed Release Omeprazole (Prilosec®)
ORLANDO, Fla.--(BUSINESS WIRE)--Nov 14, 2011 - POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented positive results today from a Phase 1 study comparing a dose-timing strategy of PA32540 and clopidogrel spaced 10 hours apart as compared to synchronous administration of enteric-coated (EC) omeprazole (40 mg), enteric-coated aspirin (81 mg) and clopidogrel (300 mg loading/75 mg daily). In the Co-Rx study, PA32540, a novel combination of 325 mg of aspirin and 40 mg immediate-release (IR) omeprazole, when dosed 10 hours apart from clopidogrel, was associated with greater platelet inhibition than synchronous administration of aspirin, clopidogrel and delayed-release omeprazole (46.5% versus 39.3%, respectively, at day 7 (95% CI [2.57, 11.91]; p = 0.004). These findings are directly relevant to the treatment of patients with gastrointestinal (GI) risk who require dual antiplatelet therapy (DAPT) and gastroprotection. The data was presented at the American Heart Association's 2011 Scientific Sessions in Orlando, Florida.
"The results of the Co-Rx study provide important insights into the interaction between omeprazole and clopidogrel," said Paul Gurbel, M.D., Director of the Sinai Center for Thrombosis Research at Sinai Hospital of Baltimore, who is a lead investigator for the study and an international authority on the pharmacodynamic effects of clopidogrel stated that, "Although the clinical significance of these results is presently unknown, treatment with PA32540 may be a promising option for the secondary prevention of heart attacks and strokes in cardiovascular patients who require prolonged aspirin and clopidogrel therapy but are at risk for gastric ulcers and bleeding."
PA32540, an investigational coordinated-delivery tablet of immediate-release omeprazole, a proton pump inhibitor (PPI), layered around pH-sensitive aspirin, is being investigated for the secondary prevention of cardiovascular disease in patients at risk for developing aspirin-associated gastric ulcers. This investigational product is part of POZEN's pipeline of integrated aspirin therapies, called the PA portfolio, all of which are designed to deliver the benefits of aspirin therapy with a reduced incidence of gastrointestinal damage.
About the Co-Rx Study
The Co-Rx study was a Phase 1, randomized, open-label, two-arm crossover study in which 30 healthy subjects were treated with one of the following: A) PA32540 in the morning plus Plavix®* (clopidogrel) (300 mg) over 10 hours later on day 1 and PA32540 in the morning plus clopidogrel (75 mg) 10 hours later on days two through seven; B) EC aspirin (81 mg) plus clopidogrel (300 mg) plus Prilosec®* (EC omeprazole) (40 mg) all in the morning on day 1 followed by EC aspirin (81 mg) plus clopidogrel (75 mg) plus EC omeprazole (40 mg) all in the morning on days two through seven. Subjects were randomly assigned to treatment A or treatment B and then crossed over to the alternate treatment. Each treatment was separated by a 14-day washout period.
The primary objective of the study was to assess the effects of PA32540 and EC omeprazole (40 mg) on clopidogrel activity as measured by ex-vivo platelet aggregation using 20 Î¼M adenosine diphosphate, a commonly used platelet assay of clopidogrel effect.
The primary endpoint was the percent inhibition of platelet aggregation (IPA) 2 hours after last dose on day seven of each period. In the study, PA32540 in the morning, plus clopidogrel 10 hours later, resulted in a significantly greater IPA than EC aspirin (81 mg) plus EC omeprazole (40 mg) plus clopidogrel administered synchronously.
* Plavix® is a registered trademark of Sanofi Aventis Corporation; Prilosec® is a registered trademark of the AstraZeneca AB group of companies.
About Antiplatelet Therapy
Aspirin is the standard of care for the reduction of an individual's risk of a second heart attack. Clinical studies have found that a daily aspirin regimen for people who have experienced a previous heart attack reduces the risk of a second heart attack by about one third. Clopidogrel and aspirin are currently co-prescribed in some cardiovascular patients. However, the use of clopidogrel plus aspirin increases the risk of GI bleeding in certain patients. These at-risk patients may benefit from the use of gastroprotective agents such as PPIs, including omeprazole. Recently, the U.S. Food and Drug Administration (FDA) modified the clopidogrel and omeprazole labels to include warnings against co-prescribing omeprazole and clopidogrel, based on ex-vivo platelet aggregation studies.
POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years – something almost no other small pharmaceutical company has done. Funded by these two milestone/royalty streams, POZEN is now creating a portfolio of cost-effective, evidence based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
The Company's common stock is traded on The NASDAQ Global Market under the symbol “POZN”. For more detailed company information, including copies of this and other press releases, please visit www.pozen.com.
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on current market data and research (including third party and POZEN sponsored market studies and reports), management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on GlaxoSmithKline for the sales and marketing of Treximet® and our dependence on AstraZeneca for the sales and marketing of VIMOVO™; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended September 30, 2011. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Contact: POZEN Inc.
Bill Hodges, Chief Financial Officer
Manager, Investor Relations & Public Relations
Posted: November 2011