BioCryst completes first Phase III clinical trial of once-daily peramivir for acute influenza
BioCryst Pharmaceuticals, Inc. has completed patient enrollment for the first Phase III trial of once-a-day orally administered peramivir (RWJ-270201), BioCryst's influenza neuraminidase inhibitor. The multicenter, Phase III clinical trial was completed in the United States during the 2001-2002 influenza season. BioCryst expects preliminary data from the trial will be available during the third quarter 2002.
The objective of the Phase III trial is to assess the efficacy and safety of peramivir for the treatment of acute influenza A and influenza B infections in otherwise healthy adults. The primary endpoint is the length of time from the first dose to the clinically significant relief of influenza symptoms.
Peramivir is a novel, potent, orally active and selective small-molecule pharmaceutical designed to block the viral enzyme neuraminidase, which is located on the surface of the influenza A and B viruses. Neuraminidase assists in the release and spread of the flu virus. Inhibiting the neuraminidase enzyme prevents the spread of the virus.
Influenza, commonly known as the flu, is a viral infection characterized by symptoms including fever, cough, sore throat, fatigue, headache, and/or chills that can leave its sufferers bedridden. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 35 to 50 million Americans come down with the flu annually. The flu is particularly dangerous to the elderly, young children and debilitated patients. The flu and related complications account for more than 100,000 hospitalizations and more than 20,000 deaths in the United States each year.