As the Wuhan coronavirus relentlessly engulfs the world, scientists are relentlessly looking for a way to treat the infection. A vaccine is more than a year away, but an antiviral drug called remdesivir is being evaluated in clinical trials by Gilead Science, the world's premier antiviral drug company. Keep your fingers crossed. Although it is better to prevent an infection than treat one, sometimes drugs can be so effective in treating infections that the distinction becomes nebulous.
If so, Gilead, the world's premier antiviral pharmaceutical company, will have pulled off another miracle. Quite possibly. This is the beauty of automated cell-based assays. They can quickly test hundreds of thousands, even millions, of chemical compounds to see if any of them perform the desired result, in this case inhibiting the replication of the coronavirus, and if so, how well. But cell-based assays are only part of the process in drug discovery.
The lower the EC 50the more potent the drug. Its potency lies within the range of the three. Figure 1. The potency of four antiviral drugs in cell cultures.
But, the potency of a potential drug is only one parameter in a cell-based assay that must be considered. Cellular toxicity can be equally as important.
This is because viruses will only replicate in healthy host cells, so a compound that kills the host may also appear to be an antiviral, but it is just a cellular toxin. The higher the SI the more selective the drug. Figure 2. Dose-response curves of three drugs. The potency, toxicity, and selectivity of three potential coronavirus drugs tested by Wang et.
Its EC 50 0. Bioavailability is a measure of how well an orally administered drug gets into the bloodstream. The rest of the drug can either pass unchanged through the gastrointestinal tract and be excreted in the feces or get absorbed by the gut and be metabolized by the liver.The U. The trial, run by the University of Nebraska Medical Center along with the National Institute of Allergy and Infectious Diseases, will be conducted at up to 50 sites globally, and will test the medicine, called remdesivir, against placebo, according to the protocol.
At the time of the post on Friday, the trial was not yet recruiting patients. It's being tested in two trials in Wuhan, China, the epicenter of the outbreak, though Aylward noted slow enrollment in those studies because of declining patient numbers and trials of other medicines also being conducted.
Gilead's shares rose 4. A spokesman for the University of Nebraska Medical Center said he was unable to comment until information is publicly released. Gilead is among a dozen companies in the race to develop treatments, vaccines and diagnostic tests for the novel coronavirus.
Monday, biotech company Moderna said it had shipped the first batch of its potential vaccine to the NIAID to start human trials, sending its stock up 16 percent Tuesday. Remdesivir is an experimental antiviral drug that has shown some promise against other coronaviruses that cause SARS and MERS, but it hasn't been tested in humans with coronaviruses. It was tested in people with Ebola — which is caused by a different kind of virus — and was unsuccessful. The medicine was also used to treat the first U.
The patient appeared to improve the next day, but researchers note one patient's experience is not enough to determine whether the medicine works. Sign up for free newsletters and get more CNBC delivered to your inbox. Get this delivered to your inbox, and more info about our products and services.
All Rights Reserved. Data also provided by. Skip Navigation. Markets Pre-Markets U. Key Points. The trial will be run by the University of Nebraska Medical Center along with the National Institute of Allergy and Infectious Diseases, and will be conducted at up to 50 sites globally. The trial will test the medicine, called remdesivir, against placebo, according to the protocol, which was posted Friday. VIDEO Related Tags. News Tips Got a confidential news tip? We want to hear from you.
Meeting quota with product. Gilead is a great place to work at!! NO, not in Sales. I was a contractor and contractors do not get vacation days paid. Find jobs Company reviews Find salaries. Upload your resume. Sign in. See questions about. Ask or search question. Submit Question. Don't see your question? Post it publicly! Please don't submit any personal information. The best questions are directly relevant to Gilead Sciences.
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Asked March 21, Stressful, competitive Answered January 10, Answer See 5 answers. How do you feel about the future of Gilead Sciences? Asked March 28, The Wuhan Institute of Virology of the China Academy of Sciences, based in the city where the outbreak is believed to have originated, said in a statement on Tuesday it applied to patent the use of Remdesivir, an antiviral drug developed by Gilead GILD. Oto treat the virus. A study published in the New England Journal of Medicine last week reported a coronavirus patient in the United States was found to show an improvement after taking Remdesivir, which is also used to treat infectious diseases such as Ebola.
Gilead did not immediately respond to request for comment but last week said it was working with China to test Remdesivir for use in a small number of patients with the coronavirus. The Wuhan-based laboratory said in its statement that the patent application was filed on Jan.
However, it said it would temporarily drop its patent claims if the opportunity arose to collaborate with foreign pharmaceutical firms to fight the epidemic. Discover Thomson Reuters. Directory of sites. United States. World News. Zhang YanDavid Stanway.These randomized, open-label, multicenter studies will enroll approximately 1, patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March.
The studies will assess two dosing durations of remdesivir, administered intravenously. The initiation of these studies follows the U. Gilead has donated drug and provided scientific input for these studies, with results from those in China expected in April.
The Gilead studies will evaluate two dosing durations of remdesivir. One study will randomize approximately patients with severe clinical manifestations of COVID to receive either five or 10 days of remdesivir.
The second study will randomize approximately patients with moderate clinical manifestations of disease to receive five or 10 days of remdesivir or standard of care alone. The primary endpoint of both studies is clinical improvement, as described below. Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. Working with government agencies, non-governmental organizations and local regulatory authorities, Gilead is providing remdesivir to qualified patients with COVID on a compassionate use basis for emergency treatment outside of ongoing clinical studies.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens including Ebola, Marburg, MERS and SARS. Remdesivir has been studied in healthy volunteers and in people with Ebola virus infection.
Individual compassionate use cases are not sufficient to determine the safety and efficacy of remdesivir in treating COVID, which can only be determined through prospective clinical trials.
The first of two studies will evaluate the safety and efficacy of both a 5-day and a day dosing regimen of remdesivir administered intravenously in patients with severe manifestations of COVID Approximately participants will be randomized in a ratio to receive remdesivir mg on day one, followed by remdesivir mg each day until day 5 or 10, in addition to standard of care.
The second study will evaluate the safety and efficacy of a 5-day and a day dosing regimen of remdesivir administered intravenously in patients with moderate manifestations of COVID, compared with standard of care.
Approximately participants will be randomized in a ratio to receive remdesivir mg on day one, followed by remdesivir mg in addition to standard of care each day until day 5 or 10, compared with standard of care alone.
The primary objective of this study is to evaluate the effect of remdesivir, as measured by the proportion of participants in each group discharged by day About Gilead Sciences. Gilead Sciences, Inc. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from clinical trials involving remdesivir and the possibility that we may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir.
As a result, remdesivir may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements.
These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
View source version on businesswire. Press Releases. About Gilead-Sponsored New Remdesivir Clinical Trials The first of two studies will evaluate the safety and efficacy of both a 5-day and a day dosing regimen of remdesivir administered intravenously in patients with severe manifestations of COVID Forward Looking Statement This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from clinical trials involving remdesivir and the possibility that we may be unable to complete one or more of such trials in the currently anticipated timelines or at all.
Ok Cancel.A s anticipation mounts over the prospects for an experimental Gilead Sciences GILD drug to combat the novel coronavirus, two Wall Street analysts suggested it remains uncertain whether the antiviral therapy will be successful after assessing a new paper that examined a dozen U.
The paperpublished on a preprint server without peer review, described the epidemiology, clinical course, and viral characteristics of the first 12 U.Gilead tells developments in clinical trials of Remdesivir against coronavirus
But RBC Capital Markets analysts examined individual patient data and decided the Gilead drug showed mixed results, at best. The analysts also noted that remdesivir patients experienced nausea, vomiting, rectal bleeding, and elevated liver enzymes. As the pandemic spreads, a race is underway to develop therapies and vaccines, but also cull existing treatments for ways to combat the virus.
The Gilead drug, which was revived recently, is high on the list and testing has begun in the U. The drug maker, which distributed the drug on a compassionate use basis to several hundred patients, expects to start its own late-stage trials this month. Consequently, every twist and turn involving each product and each test will be closely scrutinized for signs of effectiveness. Even preliminary findings will be picked through for clues, given that countless lives depend on such outcomes.
The Covid response team, which includes public health officials from around the U. Besides side effects, several patients were hospitalized despite being under 60 years old and with limited comorbidities. Several also worsened in the second week of treatment, suggesting prolonged monitoring and management will be required, they wrote.
Some qualifiers are worth noting. Again, the analysis was not peer reviewed. Under the circumstances, there is likely to be a much lower bar than usual for various side effects. Moreover, the Gilead drug was typically given to patients as they worsened, so it remains possible the drug prevented them from taking an even worse turn. Finally, the analysts noted that remdesivir was given to the patients at a later stage of illness than in the clinical trials, suggesting the therapy can yield a better outcome if administered sooner rather than later.
Transient low-grade elevations in liver transaminases were observed during the Phase 1 studies in some participants — the clinical significance of these laboratory changes is not known. In these studies, no significant adverse events or laboratory abnormalities were attributed to remdesivir by study investigators.
Republish this article. That says enough to convince me we need to get on the ball!! She said they banned export of Chloroquine. I think we should start using it widely. No significant adverse events with it for Ebola victims and also good antidotal and other data coming in. We should just use it. During a pandemic, I would hope that Stat would place a high priority on managing potentially dangerous misinformation, especially anything that seems like an obvious ploy to drive up a penny stock.
Stat has been a credible life sciences news source, and I hope will remain as such. Ed — please clean up the mess or shut down the comments. Thanks for writing in. And I stepped away for a bit but tending to comments now. Appreciate you taking the time to express concern.Gilead announced on Wednesday plans for two late-stage clinical trials.
The studies will assess different doses and treatment courses of the experimental antiviral medication remdesivir in about 1, patients with COVID A sense of urgency has been placed on the drug industry to identify and develop vaccines and treatments to halt the coronavirus outbreak that has killed more than 2, people and sickened more than 82, Since it originated in China, the virus has spread to at least 40 other countries, encompassing six continents.
The efforts build on ongoing tests of the drug in China and the US. Gilead said these new studies would start enrolling patients in March "across Asian countries, as well as other countries globally with high numbers of diagnosed cases. Read more: The US is gearing up to test the first coronavirus treatments and vaccines. Here's how 6 top drugmakers are racing to tackle an outbreak that's spreading around the world.
Investors have embraced companies that may benefit financially from the coronavirus outbreak, even as the broader stock market has tumbled over fears that the coronavirus outbreak could slow the global economy. The biotech Moderna has spiked in recent days amid optimisim for its potential coronavirus vaccine. Michael Yee, an analyst at Jefferies, said that even if remdesivir works to treat coronavirus, the financial benefits to Gilead would likely be modest.
A new paper about a Gilead drug to combat coronavirus has some analysts skittish about success
The company might not be able to charge a high price for the drug, most people would only use it once for a short-time, and the company might give it away at a low cost for humanitarian reasons in some cases, he said in a research note. Health officials and experts have emphasized the potential for remdesivir. A single case reported in The New England Journal of Medicine stirred initial excitement about the drug's promise.
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Amid Coronavirus-Induced Stock Rout, This Drug Maker May Have a ‘Cure’
Andrew Dunn. Gilead Sciences just announced plans for two late-stage clinical studies to test a treatment for COVID, the disease caused by the growing coronavirus outbreak. The studies will enroll approximately 1, patients with confirmed cases of COVID across Asian countries and other areas with high rates of cases, the company said on Wednesday.
The two trials will test an antiviral medication called remdesivir, a therapy that was previously tested against the Ebola virus.