BioCryst Pharmaceuticals (Nasdaq: BCRX) announced positive results from two Phase 3 studies of intravenous (i.v.) peramivir in patients with seasonal influenza.
The studies were sponsored by BioCryst’s partner Shionogi & Co., Ltd. of Osaka, Japan and conducted during the 2008-2009 influenza season. Shionogi and Green Cross Corporation, the license holder of peramivir in Korea, co-conducted the portion of the studies in Korea.
In patients with uncomplicated seasonal influenza, Shionogi conducted a three-armed, multi-center, randomized, double-blind, multi-national Phase 3 study of i.v. peramivir that compared the efficacy and safety of a single dose of peramivir (either 300 mg or 600 mg) and treatment with oral oseltamivir phosphate 75 mg (Tamiflu((R))) twice a day for five days.
A total of 1,099 patients were enrolled at 146 centers (Japan:100; Korea:25; Taiwan:21). Both the 300 mg and 600 mg single dose peramivir groups demonstrated non-inferiority for the primary endpoint, time to alleviation of symptoms (TTAS), compared to the oseltamivir group. The medians for TTAS for the peramivir 300 mg, peramivir 600 mg and oseltamivir groups were 78.0 hours, 81.0 hours and 81.8 hours, respectively.
“The clinical outcomes of these Phase 3 studies are important, especially during the declared influenza pandemic, as they indicate the promise of peramivir as a treatment for influenza,” commented Dr. William P. Sheridan, Chief Medical Officer of BioCryst. “The need for additional anti-viral treatment options for influenza remains high. BioCryst is currently finalizing its plans for peramivir Phase 3 studies intended to support U.S. regulatory approval, while continuing to support the pre-emergency use authorization review of peramivir by the U.S. Food & Drug Administration.”
“This data represents a significant milestone for BioCryst — the first Phase 3 studies successfully conducted with a drug candidate discovered by BioCryst,” said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. “We congratulate Shionogi on the success of these rapidly completed studies, which have the potential to lead to the first regulatory approval for peramivir.”
Source: BioCryst Pharmaceuticals, USA