Shionogi's experimental drug, taken in a single dose, works against A- and B-strain flu viruses
Far-UVC lamps, still in development, destroy germs on environmental surfaces
New ways of preventing and treating the flu are on the horizon.
One experimental treatment developed by researchers in Japan has garnered plenty of attention, but only time will tell whether or not the drug is worthy of whole-hearted enthusiasm.
In October, Shionogi & Co. Ltd., based in Osaka, reported that its experimental drug baloxavir marboxil reduced influenza viral load to undetectable levels – killed the virus – within 24 hours for more than half of the 414 participants in a study.
However, Tamiflu, the antiviral many people now use to fight the flu, similarly destroyed the virus within 24 hours, though in only 9% of 346 patient participants, the company reported.
Shionogi also studied how long the drug took to relieve symptoms. Patients treated with baloxavir marboxil saw their symptoms alleviated, on average, in 53.7 hours; those given a placebo averaged 80.2 hours, the company said.
The drug ended fever significantly faster than the placebo (24.5 hours vs. 42 hours) and caused slightly less side effects, such as vomiting, than Tamiflu.
The drug works by disrupting the flu virus’ ability to infect cells in a different way than Tamiflu, according to the company.
In a statement, the company said that in nonclinical studies conducted in the laboratory and on mice, the experimental drug demonstrated efficacy against seasonal flu strains as well as Tamiflu-resistant flu strains. The drug also proved effective against avian flu strains (such as H7N9) “of which potential outbreak is one of several global public health concerns,” according to the company.
Shionogi believes the single dose necessary for treatment should help patients take the treatment as required. Tamiflu, by contrast, requires multiple doses over several days.
The company is working with Swiss pharmaceutical company F. Hoffmann-La Roche Ltd. to develop and commercialize the drug, which is not yet available either in Japan or globally.
The company reported in October that it will submit applications to both Japan’s drug regulatory agency and the US Food and Drug Administration yet did not outline additional international plans for gaining drug approval. Considering this time frame, the drug will not become available in the United States for at least two years.
The evidence indicates that Shionogi has developed a safe and effective flu treatment, however, as with any new drug, the real world experiences of thousands of sick patients will determine its true value.
Meanwhile, instead of treating the flu, other researchers are trying to prevent people from getting sick.
Let there be light
Your local nail salon uses ultraviolet light as a germ killer, and so do hospital operating rooms. In the future, we may all be using a certain type of UV light to kill germs in offices, in schools or even in our own homes, said Dr. David Brenner, director of the Center for Radiological Research at Columbia University in the US.
Superbugs, bacteria that are resistant to traditional antibiotics, are a growing problem worldwide. Brenner declared his personal “war on superbugs” after a friend – “a healthy guy in the prime of life” – died of an infection following minor surgery. He believes antibiotics administered to an infected patient are not the only way to fight superbugs or other germs and viruses.
UV light is the short-wavelength section of the spectrum that includes infrared and visible light. Scientists have known for more than a hundred years that it can kill every kind of microbe, Brenner said.
Unfortunately, UV light is a health hazard for humans. Conventional UV light can damage our skin and our eyes, causing cancer and cataracts.
Yet the short-wavelength part of ultraviolet – known as far-UVC light – is different from conventional UV light in its ability to penetrate materials and so destroy them.
While far-UVC light can destroy microbes, it cannot penetrate even the dead cell layer of our skin’s surface. For this reason, Brenner reasons far-UVC light might be the solution to the problem of a wide-acting germicide.
Brenner’s lab has been testing his theory for five years.
“We have never seen any biological effects / DNA damage from far-UVC light in the skin or eye,” he said. With safety studies expected to be done within a year, “next year’s flu season is our optimistic target” for a product to go to market.
But will we all look strange under the new germicidal lamps he has conceived?
“Far-UVC light is invisible, though the far-UVC lamp emits some visible purple light also,” he said. “We all look better when we don’t have the flu, of course!”
The air we breathe
Another non-pharmaceutical approach to preventing influenza is air cleaning.
Aerosol researchers have developed a technology that effectively removes disease particulates, including influenza germs, from the air. The experimental technology includes an electrostatic filter capable of “capturing all kinds of particles, including viruses and bacteria,” said Pratim Biswas, the lead researcher and a professor at Washington University in St. Louis.
Not only does the air purification technology capture potentially infectious particles “with extremely high efficiency,” it kills them, he said.
Essentially, the technology displaces a charge on the particles, uses an electrical field to trap them and then deactivates any harmful pathogens, he explained. The filter can be used within HVAC (heating, ventilation, and air conditioning) systems, in which, unlike a conventional filter-based device, it would not become a breeding ground for germs and microbes, said Biswas.
The National Institutes of Health funded testing of the filter, which proved successful in destroying biological agents in the laboratory “from poliovirus to anthrax to flu virus,” Biswas said. “We’ve done very extensive testing over the last five to seven years.”
“It’s already available in pilot form,” Biswas said. With Jiaxi Fang and Tandeep Chadha, both of Washington University in St. Louis, Biswas created a startup company, Applied Particle Technology, to work on commercializing the product.
The startup is working with hospitals to prepare the filter for deployment and testing in a clinical environment.
Ultimately, the invention may function as a “smart filtration system” in medical offices, clinics, hospitals and nursing homes to help prevent increasingly common hospital-acquired infections, Biswas said.
Someday, commercial settings and homes may also benefit from the technology – “not to mention the indoor air quality problems that many parts of the world are facing,” he said.
We inhale no less than a million particles with each breath we take in a reasonably clean room, he noted. Because the filter would ensure cleaner, more breathable air, Biswas hopes it soon becomes available for home use, though no market date has been set.
Finally, another pharmaceutical company is working hand in hand with the American government to develop its own new treatment for the flu.
Another weapon in the armature of flu warriors may be pimodivir, an experimental drug discovered by Boston-based Vertex Pharmaceuticals and in development at a Johnson & Johnson subsidiary, Janssen Pharmaceuticals, Inc.
Pimodivir works by targeting and inhibiting part of the virus replication process. Its mode of action is unlike that of existing antiviral drugs, so its makers say the drug may treat influenza A virus infections that have developed resistance to existing drugs.
In June, Johnson & Johnson announced that pimodivir significantly decreased the viral load in adult patients with seasonal flu over seven days. Patients treated with pimodivir and oseltamivir (Tamiflu) also showed a significant reduction in viral load compared with people who received pimodivir alone at the same dose.
The researchers say there were no significant safety concerns with pimodivir, though some patients experienced diarrhea and nausea.
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Pimodivir received FDA fast-track designation in March. Pimodivir is funded in part by the Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services.
There are two ongoing studies where the drug’s efficacy is being tested by treating hundreds of sick patients, according to Johnson & Johnson spokeswoman Katie Buckley.