The federal government is meting out $102.6 million to BioCryst Pharmaceuticals Inc. to fund the advanced development of the influenza antiviral peramivir over the next four years.
Specifically, the money will be used for worldwide Phase II and III studies, manufacturing for those trials and production process validation, as well as other approval requirements. Peramivir has shown effectiveness against a number of flu strains in laboratory studies to date, and it's hoped that further testing will prove its ability to treat seasonal and life-threatening flu, including the highly pathogenic H5N1 strain.
BioCryst Chairman and CEO Charles Bugg said he's "very encouraged" that the compound cleared the government's "very detailed vetting process," and he told BioWorld Today that peramivir should enter Phase II this flu season. "We're putting in place a broad program in order to be able to capture as much flu as we can rapidly by moving to different parts of the world," as the infection circles the globe throughout the year.
And going forward, that extensive development plan won't tax the Birmingham, Ala.-based company's burn rate. The news boosted BioCryst's shares by 8.1 percent on Thursday, with the stock (NASDAQ:BCRX) gaining 90 cents to $12.07.
The contract comes from the Department of Health and Human Services, and eventually, peramivir could be purchased by the government for the national stockpile to expand its ability to quickly respond to a potential pandemic. But it's also expected to find general public use, and the contract is part of a larger HHS initiative to collaborate on the development of more products to treat and prevent all forms of the flu.
The neuraminidase inhibitor is being developed as an injectable product, both in intravenous and intramuscular formulations, to cover the spectrum of patients from the mildly infected to the more acutely ill. The former could prove most beneficial in hospital settings for emergency room use, since such delivery allows high levels of the drug to be achieved rapidly throughout the body in people who might be too ill to take oral medications. The latter could benefit less severely afflicted people who could be treated on an out-patient basis.
It's hoped that a single intramuscular injection of the drug can confer benefit to mild patients, and a 20- to 30-minute infusion for severe patients.
"It really adds a new dimension to how we can go about tackling the flu," Bugg said. "By injection, you can achieve really high levels of the drug quickly, blood levels that potentially would allow you to overwhelm even the most virulent strains of flu."
Recently reported Phase I data showed that such levels could be achieved safely in healthy subjects, and they're reached "essentially instantaneously," Bugg said. In addition, preclinical findings have demonstrated its ability to prevent deaths in animals infected with the H5N1 strain at those high levels.
In contrast, other antiviral flu drugs already included in the national stockpile, Tamiflu (oseltamivir, from Gilead Sciences Inc. and F. Hoffmann-La Roche Ltd.) and Relenza (zanamivir, from GlaxoSmithKline plc), don't achieve such rapid uptake because they're dosed orally and through an inhaler, respectively. In addition, Bugg said peramivir remains effective against flu strains that have exhibited resistance to Tamiflu, and by delivering it at high levels should minimize the chance of generating resistance.
The H5N1 virus has not been found in the U.S. in either birds or humans, though it is widespread in bird populations in Asia, Africa and Europe.
The FDA has designated injectable peramivir a fast-track product, and over the years, it has received research support from the National Institutes of Health. Eventually, additional efforts also could examine its use as a prophylaxis against flu infection.
Outside of the program, BioCryst also is focused on a late-stage cancer drug, Fodosine (forodesine), which is in a Phase III trial for acute lymphoblastic T-cell leukemia. The compound, which is partnered overseas with Cambridge, UK-based Mundipharma International Holdings Ltd., also is being studied in other cancer indications. Additionally, BioCryst and Basel, Switzerland-based F. Hoffmann-La Roche Ltd. are involved in a worldwide partnership for a compound called BCX-4208 for transplantation and autoimmune diseases.