BIOCRYST LAUNCHES STUDY OF SEASONAL FLU DRUG

BioCryst Pharmaceuticals has initiated a Phase II clinical trial of peramivir, the company's lead influenza neuraminidase inhibitor, to determine the safety and efficacy of an intramuscular formulation of the drug in patients with influenza. Peramivir is in clinical development for the treatment of acute seasonal influenza.

The study is based on the positive Phase I clinical data obtained in 2006. The safety and antiviral activity observed indicates that injectable peramivir may be a valuable therapy in the treatment of acute influenza.

The double-blind, placebo-controlled trial will enroll patients with acute influenza at sites in North America, Europe and Southeast Asia. Two different doses of peramivir will be tested.

Funding for this trial will come from the HHS, which earlier this month awarded BioCryst a $102.6 million, four-year contract to develop peramivir for the treatment of seasonal and pandemic influenza. Under the terms of the contract, the company will be reimbursed for clinical manufacturing and evaluation of peramivir through to licensure.

Peramivir is a member of the class of antiviral agents that inhibit influenza viral neuraminidase, an enzyme that is essential for the spread of influenza virus within the host. In laboratory tests peramivir has been shown to be more potent than currently available neuraminidase inhibitors.