SAN MATEO, Calif., Sept. 24 /PRNewswire/ -- Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Protocol Assessment procedure. At the same time, the company received Scientific Advice from the European Medicines Agency (EMEA) on Anthera's European development strategy for varespladib. Guidance from both regulatory agencies regarding varespladib will be incorporated into Anthera's global registration program slated to start next year.
Anthera's Special Protocol Assessment supports a single, pivotal, Phase 3 trial evaluating varespladib, in combination with Lipitor(R) (atorvastatin) as first-line treatment within 96 hours of an ACS event. In the European Union, Anthera received Scientific Advice that supports a similar clinical development program and include the potential to also utilize varespladib as an adjunctive treatment in patients with stable coronary disease and elevated levels of LDL-C and total cholesterol.
"We are pleased that both agencies recognized the potential of varespladib's multiple therapeutic effects in patients with cardiovascular disease," said Paul Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "The anti-inflammatory effect and safety profile seen in the varespladib trials to date are very exciting and highlight the opportunity to help patients with recent coronary events."
"The regulatory clarity in the United States and Europe reinforces our confidence that we can efficiently deliver a novel therapeutic for patients with ACS," said Dr. Ursula Fritsch, Vice-President Global Regulatory and Compliance. "With this regulatory feedback, we have a clearly defined and reasonable development path to deliver a first in class therapeutic for ACS patients and individuals with hypercholesterolemia."
"The recent publication of clinical data at the European Society of Cardiologists by GlaxoSmithKline on the effect of their selective Lp-PLA2 (lipoprotein-associated phospholipase A2) inhibitor, darapladib, on a secondary biological outcome while having no effect on inflammation or LDL-C, provides encouraging validation of the anatomical importance of reducing PLA2 activity in a cardiovascular population," said Dr. Robert S. Rosenson, Director of Lipoprotein Disorders and Clinical Atherosclerosis Research at the University of Michigan. "The on-going FRANCIS trial with varespladib, which is designed to evaluate and repeat the results of previous clinical data from PLASMA and PLASMA2 in an ACS population, should provide additional data on an already validated predictor of cardiovascular risk (LDL-C) coupled with reductions in PLA2."
In previous clinical trials, varespladib, a potent and highly selective inhibitor of secretory phospholipase A2 (sPLA2), has demonstrated marked improvements in independent markers of cardiovascular risk including, a near complete suppression of the target enzyme sPLA2, clinically meaningful and statistically significant reductions in "bad" LDL cholesterol, and a reduction in C-reactive protein, a known marker of inflammation.
Presently, the company is conducting the five hundred patient FRANCIS trial (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) to assess the impact of oral varespladib on known biological markers of cardiovascular risk in ACS patients with elevated LDL and CRP. FRANCIS will also provide insight into the prevention of secondary Major Adverse Cardiovascular Events (MACE) over the duration of the six-month trial.
About Acute Coronary Syndrome
Acute coronary syndrome is a heart condition characterized by chest pain occurring at rest or upon minimal exertion. This condition is also referred to as unstable angina. If the chest pain is associated with heart muscle damage and heart tracing abnormalities, it is typically classified as a heart attack or myocardial infarction.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a privately held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company 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 group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes‚ prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel‚ upstream steps in the inflammation cascade and have the potential to address a variety of diseases. The company has also acquired exclusive and worldwide rights to a peptide fusion protein, A-623, for the treatment of autoimmune diseases from Amgen. For more information, please visit http://www.anthera.com.
INVESTOR AND MEDIA CONTACT: Anne Bowdidge, (650) 218-6900, firstname.lastname@example.org
|SOURCE Anthera Pharmaceuticals|
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