experimental drug

Japanese Company Claims Experimental Drug Kills Flu Virus in a Single Day

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In the midst of one of the worst flu seasons in several years, a Japanese pharmaceutical company says it has an experimental drug that could make next winter a lot less sickly – not to mention safer.

Drugmaker Shionogi claims its influenza virus treatment baloxavir marboxil, which is not yet on the market, is faster-acting than any other flu drug available, with just one dose of the medication effectively killing the virus within a single day.

In a Phase 3 clinical trial reported last year, the average amount of time the compound took to wipe out the virus in otherwise healthy adults was just over 24 hours.

In contrast, participants treated with one of the most common flu medications, oseltamivir (sold under the brand name Tamiflu), took 72 hours, and people taking a placebo required 96 hours to beat the virus.

While the overall time to alleviation of symptoms was similar whether participants took baloxavir marboxil or oseltamivir, Shionogi says its experimental drug provides immediate relief faster, which might curb the virus’s contagiousness in people who take the treatment.

The oral drug works via a different biological mechanism to oseltamivir, which is a neuraminidase inhibitor, blocking an enzyme the virus uses to reproduce itself in infected cells.

By contrast, Shionogi developed baloxavir marboxil by leveraging discoveries made in anti-HIV drugs, targeting a different kind of enzyme and preventing cells from susceptibility to virus infection in the first place.

Another benefit is the single dose delivery, compared to oseltamivir’s 10-dose regimen (two doses daily for five days), which isn’t necessarily just a question of convenience, the drugmakers say.

“The advantage is that it’s one pill once, versus a course of therapy, so particularly for pandemic planning, this could be an advantage,” the head of co-developer Roche’s pharma unit, Daniel O’Day, told Bloomberg.

“You don’t have the potential resistance that comes with not completing your course of therapy.”

According to Japanese newspaper The Asahi Shimbun, the drug, which targets both the A and B types of influenza virus, received a green light from a Japanese government health ministry panel in early February, indicating a likely go-ahead for imminent manufacture and sale of the drug.

Formal approval to do so is reportedly being fast-tracked and is expected to come in Japan next month, which means the treatment could be on sale there as soon as May.

As for future availability in the US and elsewhere, that’s less clear right now.

According to The Wall Street Journal, Shionogi – together with Tamiflu maker Roche, who will have the rights to distribute baloxavir marboxil internationally – will apply for approval to sell the drug in the US this summer, with a decision expected to come sometime in 2019.

Of course, what that means is that baloxavir marboxil won’t be helping any of us out this flu season, but that doesn’t mean we can’t protect ourselves from the virus in the meantime.

While we all wait for the long-anticipated universal flu vaccine to arrive, the regular flu vaccination is still your best bet at the outset of any flu season.

Beyond vaccination, there’s a handy shortlist of things to know about the flu for this year, and a number of evidence-based things you can do to help avoid the worst of the flu (and to beat colds too) – including some things you might not exactly expect.

How an Experimental Drug Becomes an Approved Therapy.

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Ever wondered what it takes for a potential cystic fibrosis drug to become FDA-approved? Here’s an explanation of the four phases of clinical research.

This is an exciting time for cystic fibrosis research, with more than two dozen potential drugs being tested in clinical trials.

But in order for any new drug to become available to the public, it must pass through three phases of clinical trials to show that it is safe and effective in treating the disease, and receive approval by the U.S. Food and Drug Administration (FDA). If the FDA approves the drug, it will continue to be monitored for safety and effectiveness in what is known as a Phase 4 study.

Here’s a breakdown of the questions that researchers try to answer, the number of participants needed and the time per participant for each phase of research.

Christina-Roman-Phases-of-Clinical-Research-Graphic

Because there are so many promising new research opportunities, as many people with CF as possible are needed to participate in clinical trials.

Check out our Drug Development Pipeline to find out where new drugs are in the clinical trial process.

New drug cures Ebola-related virus in monkeys

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An experimental drug has been shown to halt the replication of the Marburg virus – a relative of Ebola – and can cure a patient after several days of infection.

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Image: anyaivanova/Shutterstock

A study led by Thomas Geisbert, a professor of microbiology and immunology from the University of Texas in the US, tested a new intravenous drug on 16 rhesus macaques infected with the Marburg virus. The researchers involved reported that all 16 monkeys lived after the treatment, whereas five infected monkeys that did not receive the treatment died in just over a week.

This is the first time any drug has been able to cure a lab animal from this particular strain of the Marburg virus, and because it belongs to the same family of viruses as Ebola, the team is now working on adjusting it to suit Ebola patients. According to Geisbert, they’re combining their new drug with another experimental drug designed to be like ZMapp, which was an anti-Ebola drug used by infected American missionaries working in Liberia. The global supplies of ZMapp have recently run out.

So far no drug has been approved for the prevention or treatment of Marburg or Ebola, but according to a paper published by Geisbert and his colleagues in the journal Science Translational Medicine, their drug starts attacking the virus the minute it gains access to the cell.

“The Marburg drug consists of sections of ‘small interfering RNA’ (siRNA), or silencing RNA, which are created in the lab and packaged in microscopic envelopes called lipid nanoparticles that can be absorbed by cells,” says Monte Morin at the LA Times. “Once inside the cell, the siRNA hampers viral reproduction by degrading messenger RNA and shutting down the production of viral proteins.”

“Maybe the best analogy I can give is the messenger RNA is a blueprint for how the virus makes more of itself, and the siRNA kind of interferes or blocks that ability for it to kind of follow its recipe to make proteins,” Geisbert said in a recent statement to journalists.

According to Morin at the LA Times, Geisbert and his colleagues have begun Phase 1 trials of their new Ebola drug and hope to work their way up to human trials as soon as possible.