HAYWARD, Calif., May 3 Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced detailed results from a new biomarker analysis of the FRANCIS study. FRANCIS examined the effects of once-daily varespladib vs. placebo as an adjunct treatment to high-dose atorvastatin and standard of care on inflammatory biomarkers known to be predictive of secondary cardiovascular events in patients with a recent acute coronary syndrome (ACS). This new analysis examines the anti-inflammatory effects of varespladib, an inhibitor of secretory phospholipase A2 (sPLA2), in diabetic patients with a recent ACS.
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This pre-specified analysis of diabetic patients demonstrated treatment with varespladib was associated with early and statistically significant improvements in inflammatory markers, including C-reactive protein (CRP), low-density lipoprotein-cholesterol (LDL-C) and varespladib's target enzyme, sPLA2. Varespladib's treatment effect was incremental as compared with 80mg of Lipitor (atorvastatin calcium) and standard of care. These improvements were seen at all measured time points, up to and including week 8, the primary endpoint of the FRANCIS trial. In addition, interleukin-6 (IL-6), a short half-life pro-inflammatory cytokine, which also is associated with increased cardiovascular risk, demonstrated a statistically significant reduction through week 4. The data have been submitted to an upcoming medical conference.
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"ACS patients with underlying diabetes are at an elevated risk of cardiovascular events due to higher levels of inflammation. The medical community has expressed interest in understanding the level of impact varespladib could have on this difficult-to-treat patient population," stated Colin Hislop, M.D., Anthera's Senior Vice President of Cardiovascular Products. "These new data, combined with data from the broader FRANCIS study population, further support our hypothesis for the VISTA-16 Phase 3 study in high-risk ACS patients with elevated levels of inflammation."
About Varespladib and sPLA2
Anthera Pharmaceuticals' varespladib is a potent and highly selective inhibitor of secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS and acute chest syndrome, as well as chronic diseases, such as stable coronary artery disease (CAD). In Anthera's FRANCIS clinical study in ACS patients, varespladib (A-002) demonstrated marked improvements in independent markers of cardiovascular risk including C-reactive protein, IL-6, LDL-C and our target enzyme sPLA2. In February, the Company received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the VISTA-16 Phase 3 study for the use of varespladib in high-risk ACS patients.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 ready clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as secretory phospholipase A2, or sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease, or CAD. Anthera's Phase 2 ready product candidate, A-623, targets elevated levels of B-lymphocyte stimulator, or BLyS, which has been associated with a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus, or lupus. For more information, please visit www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera's clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera's products through future stages of clinical development. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company's public filings with the Securities and Exchange Commission, including Anthera's final prospectus relating to its initial public offering filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, on March 2, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events, or otherwise, except as required by applicable law.
CONTACT: Juliane Snowden of Burns McClellan, Inc., [email protected] or 212.213.0006.
SOURCE Anthera Pharmaceuticals, Inc.
