BioCryst (BCRX) surges on flu drug trial results
Shares of BioCryst Pharmaceuticals (NASDAQ: BCRX), the life-sciences component of Stockhouse wealth service Ticker Trax (TM), soared 41% to $5.95 Friday, after the Birmingham, Alabama-based biotech firm announced positive results from two Phase 3 studies of its influenza treatment, intravenous peramivir, in patients with seasonal flu.
BioCryst’s partner, Japan’s Shionogi & Co conducted a three-armed, multi-center, randomized, double-blind, multi-national Phase 3 study during the 2008-2009 flu season, comparing the effectiveness and safety of a single dose of peramivir to treatment with Tamiflu twice a day for five days.
The company says that both the 300 mg and 600 mg single dose peramivir groups demonstrated “non-inferiority for the primary endpoint, time to alleviation of symptoms” compared to the Tamiflu group.
Shionogi also conducted a double-blind, multi-center Phase 3 study of i.v. peramivir with dosing over multiple days.
“I.V. peramivir 300 mg and 600 mg in both single and multiple doses were generally safe and well-tolerated in these trials,” says the company.
“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,” said 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,” he added.
Shionogi says it is “making its best effort” to file its New Drug Application and to receive manufacturing approval in Japan for the treatment as soon as possible.
Thom Calandra’s Ticker Trax (www.tickertrax.com), a subscription service of Stockhouse, named BioCryst as one of 8 Planetary Prospects in December 2008. At the time, the shares were selling on NASDAQ for $1.70. On Friday, the shares went as high as $6.43 in early trading. Mr. Calandra says he has researched BioCryst and its crystallography compound discovery process for the past four years. He says BioCryst is valuable as a developer of treatments for psoriasis, influenza, leukemia (which is undergoing a Phase III trial) and cardiac arrest.
Mr. Calandra said he was somewhat concerned the larger dose of peramivir was no more effective than the lighter one. Still, he said he will be telling his Ticker Trax subscribers that he intends following the company and holding his large position in the shares for at least the next five to seven months, given the severity of the coming Northern Hemisphere influenza season.
