The 'most promising' coronavirus treatment faces its biggest test yet. Clinical data for Gilead's drug remdesivir is coming in a matter of weeks.
- The first clinical trial results are nearing for remdesivir, an experimental antiviral drug that the World Health Organization has called "the most promising candidate therapy" for this coronavirus outbreak.
- Researchers in China are enrolling more than 750 patients with COVID-19, the disease caused by the novel coronavirus. Both studies are expected to produce results in April.
- The California biotech Gilead Sciences makes remdesivir, and is planning to start two additional trials later this month. The National Institutes of Health is also enrolling COVID-19 patients near hospitals in Washington state and Nebraska to test remdesivir against a placebo.
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One of the biggest tests yet is nearing in the scramble to respond to the global coronavirus outbreak.
Over the past few weeks, Chinese researchers have enrolled hundreds of hospitalized patients suffering from COVID-19, the disease caused by the novel coronavirus, into clinical trials. Two studies are now set to produce data within the next few weeks on an experimental antiviral drug that top public health officials have highlighted as a leading potential treatment option.
That antiviral drug is called remdesivir and it's made by the biotech giant Gilead Sciences. While other drugmakers have begun to develop coronavirus vaccines or new drugs to fight COVID-19, those efforts will likely take months, if not years, as they advance through multiple tests to determine whether the treatments are safe and can halt the virus.
By contrast, remdesivir has a head start, because Gilead has been working on the drug since 2009, and has already shown it's safe for people to take. We'll get the first data showing if it works to fight COVID-19 in humans in a matter of weeks. Gilead executives have said they are expecting the information some time in April.
While some other drugs for viruses like HIV are also being tested as potential COVID-19 therapies, remdesivir has emerged as a leading hope. One World Health Organization document calls remdesivir the "most promising candidate therapy."
"There is only one drug right now that we think may have real efficacy and that's remdesivir," Bruce Aylward, a WHO assistant director-general, said at a February 24 press conference.
In countering an outbreak that has infected more than 110,000 people, roiled financial markets and altered people's daily routines, positive clinical data could be a major turning point in the response to the coronavirus.
Positive results for remdesivir could help lead to "a strong market rally, adding trillions of dollars of value back for investors eager for a rebound," Evercore ISI analyst Josh Schimmer wrote in a February 28 note to investors.
How remdesivir became the best prospect against COVID-19
Gilead, with a market value of almost $100 billion, is an industry leader in fighting infectious diseases. The company makes treatments for the virus Hepatitis C, and has a broad array of drugs to fight HIV, as well, including the prevention pill Truvada. The company registered more than $16 billion in revenue last year from its HIV portfolio.
Remdesivir isn't a new drug. The research that led to the compound started in 2009, and the drug was developed as part of a broader effort to find treaments for Hepatitis C and respiratory syncytial virus, a Gilead spokesperson said. Beginning in 2013, it was tested in test tubes and animals against a wider range of viruses, showing broader antiviral activity.
Laboratory testing results published in 2017 showed remdesivir's activity in test tubes against the two other major coronavirus outbreaks of the 21st century, SARS and MERS.
"This new coronavirus is structurally similar to MERS and SARS, and in vitro testing has demonstrated that remdesivir is active against the virus that causes COVID-19," a Gilead spokesperson said in a statement to Business Insider. "It is unknown at this time whether remdesivir will demonstrate any clinical activity against the new coronavirus."
Remdesivir was also one of four medicines tested against Ebola in a 2018 study, but other therapies outperformed it. Being previously tested in hundreds of people has helped move remdesivir quickly into late-stage clinical trials, because it's already been shown to not cause severe side effects. The World Health Organization called it "relatively safe" in a February 24 assessment of the drug.
In the case of this outbreak, buzz for remdesivir took off after an anecdotal report of a COVID-19 patient improving after receiving remdesivir was published in late January in The New England Journal of Medicine.
In that account, the patient who was the first confirmed case of COVID-19 in the US received remdesivir under a compassionate use program. The patient, a 35-year-old man from Washington state, had mild symptoms that progressed to pneumonia. His symptoms improved after starting treatment on remdesivir, although the paper's authors stressed the need for further clinical research to assess the drug's effectiveness.
Why remdesivir is 'not the panacea' for this coronavirus
Even if the clinical data shows remdesivir is effective in treating COVID-19, it is unlikely to be a cure-all in itself for this virus, experts said.
Vaccines are the gold standard in counteracting infectious diseases. While developing a safe and effective vaccine is often a long and costly process, the end result holds immense public health value. Vaccines can prevent infections before they happen and keep people healthy.
A step down from vaccines is prophylactic treatments - drugs given to those at high risk of becoming infected, such as the families of those who are sick or healthcare workers.
Remdesivir isn't being used to prevent infections. It's mainly being given to those who have become seriously ill. The clinical studies include patients who have cases of COVID-19 and are in the hospital.
Remdesivir is administered as an IV infusion for 10 days. While Gilead is also planning to test a 5-day IV option in its two trials, the lengthy IV dosing period could limit remdesivir's ability to make a widespread impact, particularly for milder cases.
"Administration of this product on a mass scale solely to treat infected patients will strain resources of the healthcare system. As such, it is not the panacea of containing and treating this infection," Evercore's Schimmer said in a recent research note.
So in a best-case scenario, remdesivir may show it helps patients recover from COVID-19. But its real-world use would likely be limited to more severe cases.
From a business perspective, Gilead has not yet released a pricing plan for remdesivir. Some Wall Street analysts have mentioned the possibility that the biotech could price the drug at-cost or even give it away, similar to how the company pledged last year to donate more than 2 million bottles of its HIV treatment.
Raymond James analyst Steven Seedhouse wrote in a recent note to investors that such a donation could help Gilead politically.
What to watch in clinical testing
There are five remdesivir trials to watch, with three already in progress.
The first look at whether the drug works will come from two late-stage clinical trials being run by researchers at the China-Japan Friendship Hospital in Beijing. These trials started in early February.
One of those studies is focused on mild-to-moderate cases while the other focused on severe cases. Combined, the two studies are enrolling more than 750 patients, and randomly assigning them to either a 10-day infusion of remdesivir or a placebo. Both studies required the patients to be hospitalized and have confirmed COVID-19 cases.
The third active trial is being led by the National Institutes of Health, enrolling COVID-19 patients in Nebraska and Washington state. That study plans to eventually add research sites around the globe as well as a variety of different treatment options to test.
The final two studies, which are still in the planning stages, will be run by Gilead. These will also test a 5-day course of remdesivir. These final two trials will combine to enroll about 1,000 moderate to severe patients across Asian countries and other areas with high case rates.
A Gilead spokesperson said these two studies will begin enrolling patients this month and could provide results as early as May.
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