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Anthera's Varespladib Meets Primary Endpoint In Phase 2 FRANCIS Test For The Treatment Of Acute Coronary Syndrome

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Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical business developing anti-inflammatory drugs, announced that FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression), a clinical evaluation designed to look the crunch of 500mg of varespladib when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event, met its relevant endpoint of a reduction in Low Density Lipoprotein Cholesterol (LDL-C). All patients in the FRANCIS trial received once diurnal doses of 80mg of Lipitor (atorvastatin calcium), plus 500mg of varespladib or matching placebo. Varespladib is a potent and highly selective uttered inhibitor of secretory phospholipase A2 (sPLA2), an inflammatory enzyme implicated in ACS, vascular inflammation, atherosclerosis and adverse lipid profiles.
The pre-specified important endpoint conversation was conducted when 500 patients reached at least eight weeks of treatment after an ACS event. In appendix to meeting the essential endpoint, additional efficacy analyses at a variety of time points showed consummate results for all clinically important secondary endpoints. The initial news fresh look demonstrated:
-- A statistically significant reduction in LDL-C at all prospectively defined allotment points and statistically forceful reductions in complete cholesterol and non-HDL cholesterol
-- Varespladib's immediate and selective inhibition of sPLA2 effectively suppressed inflammation following the index celebration and was extremely evidenced by a statistically significant reduction in C-reactive protein.
-- A statistically significant in a superior way proportion of patients treated with varespladib achieved LDL-C levels of 70mg/dL or less (a cause established by the American Treatment Programme III for high-risk patients) and maintained this lower common throughout the primary endpoint. The effect was another pronounced for patients achieving LDL-C below 50 mg/dL.
"Building on brawny results from our aboriginal two clinical studies in stable cardiovascular patients, the FRANCIS interpret has validated the potential assistance of aggressive varespladib treatment to improve outcomes in a high-risk patient population immediately next an ACS event," said Paul F. Truex, Head of the state and Manager Executive Officer of Anthera Pharmaceuticals, Inc. "In addition to meeting the meaningful and many secondary endpoints, clinical information from the FRANCIS scan has met and/or exceeded our expectations and we confidence to in process the entire facts set including biomarkers, safety, and secondary clinical endpoints (MACE) at an upcoming scientific conference."
"We are exceedingly discomposed by these data," said Colin Hislop, M.D., Senior Vice President Clinical Advancing at Anthera. "The favourable treatment effect of varespladib is consistent with our Sheet 3 method plan and provides a robust material set to relieve substantial clinical boon for this novel, first in class therapy."
With encircling 1000 patient exposures to period in three cardiovascular studies, varespladib has been generally flourishing tolerated.
About the FRANCIS trial
The FRANCIS analysis is based upon direct feedback from Nourishment and Drug Control via the Special Protocol Assessment process. FRANCIS was designed to assess the impact of oral varespladib on known biological markers of cardiovascular risk. It enrolled 625 patients who testament be treated for a minimum of six months. The study is being conducted at sites in Europe. FRANCIS is designed to provide observation into the potential prevention of secondary Hefty Adverse Cardiovascular Events (MACE) by varespladib. In this study, MACE was defined as a composite endpoint consisting of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, unstable angina, and a subset of revascularization adjacent the initial event. During the course of the study, patients received therapeutic morals of care in addition to high potion Lipitor (atorvastatin).
In preceding clinical trials, varespladib, a potent and highly selective inhibitor of secretory phospholipase A2 (sPLA2), has demonstrated clear improvements in independent markers of cardiovascular risk including, a near complete suppression of sPLA2 lifetime and mass, clinically meaningful and statistically significant diminution in LDL cholesterol, and a reduction in C-reactive protein.
About Acute Coronary Syndrome
Acute coronary syndrome is a affection condition characterized by chest anxiety occurring at rest or upon minimal exertion. This case is also referred to as unstable angina. Provided the chest bitterness is associated with heart muscle damage and heart tracing abnormalities, it is typically classified as a heart blitz or myocardial infarction.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that direction unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Firm has acquired from Eli Lilly and Company and Shionogi & Co. Ltd. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase (PLA2) family - a battery of enzymes amenable for the proceeds of arachidonic acid and subsequent production of leukotrienes prostacyclins and other mediators of inflammation. These highly potent compounds inhibit tale upstream steps in the inflammation falls and have the potential to directions a collection of diseases.
Source: Anthera Pharmaceuticals, Inc
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