Anthera halts VISTA-16 heart drug trial
Anthera Pharmaceuticals (NASDAQ:ANTH) late Friday stopped a late-stage trial of its experimental drug to treat a heart disease due to lack of efficacy.
The company, which develops drugs to treat cardiovascular and autoimmune disorders, said it halted enrollment in the clinical trial, known as VISTA-16, following recommendation by the independent Data Safety Monitoring Board (DSMB).
The Hayward, California-based company was testing its drug, varespladib methyl, in patients suffering from a heart condition known as acute coronary syndrome, which includes symptoms such as chest pain caused by reduced blood flow to the heart.
In a statement, Anthera said: "Based on all the evidence we have seen regarding varespladib and secretory phospholipase, and in light of previous study results, we were surprised by the recommendation from the DSMB," the company in a statement.
Anthera's president and chief executive officer Paul F. Truex said: "While the DSMB information we received today was both surprising and disappointing, our focus is on the best interests of patients and making sure all this information is communicated to appropriate medical and regulatory authorities as quickly as possible."
The VISTA-16 trial was designed to prove the hypothesis that reduction of inflammation, particularly following an ACS, leads to improved outcomes in patients with cardiovascular disease.
The study compared a combination of varespladib, the cholesterol drug Lipitor, and other standard treatments to Lipitor, the standard treatment, and a placebo in patients who have acute coronary syndrome.
Currently, the best practice to slow coronary artery disease progression and reduce the risk of a subsequent heart attack is directed at the treatment of individual cardiovascular risk factors such as high cholesterol or clotting.
Anthera, which went public in March 2010, is currently testing two other drugs - for lupus and acute chest syndrome - in separate mid-stage trials.