ANTHERA RECEIVES APPROVAL TO BEGIN TWO PHASE II TRIALS

Anthera Pharmaceuticals announced that the FDA has approved its investigational new drug (IND) application for use of its lead compound A-001 in hospitalized patients with sickle cell disease. The IMPACTS trial is a Phase II clinical study aimed at preventing a severe respiratory complication of sickle cell disease, acute chest syndrome.

Acute chest syndrome, a form of acute lung injury, is the leading cause of death in sickle cell disease patients. Studies have demonstrated that serum secretory phospholipase A2 (sPLA2) levels rise in advance of acute chest syndrome and therefore help identify patients at-risk. This creates a unique opportunity for early intervention for a serious inflammatory lung disease with a potent inhibitor of sPLA2 such as A-001.

IMPACTS is a double-blind, randomized, parallel-group, placebo-controlled, dose-escalation study. It will enroll up to 75 hospitalized patients at 15 to 20 U.S. centers. Enrolled patients will be those at risk for development of acute chest syndrome based on the combination of bone pain, fever and an elevated serum sPLA2 concentration. The main efficacy endpoint is freedom from the development of acute chest syndrome.

Anthera also announced it has received IND approval for its lead cardiovascular compound A-002. The company will initiate a multicenter Phase II clinical trial, PLASMA, that will examine the effect of A-002 on sPLA2 levels and other well-established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease due to underlying atherosclerosis. PLASMA is expected to complete enrollment by the fourth quarter of 2007.