At least eight companies are working hard to develop a drug; But Gilead’s Remdesivir is the most promising of all – as the experts claim; Is it already in use? Are the results positive? And when will it hit the market?
The Corona virus is making the world go round, with apocalyptic images of isolated provinces, empty airports and more. The number of infections worldwide jumps daily without stopping.
The world is awaiting the arrival of the summer season in the northern hemisphere (and more sensitive to the epidemic of the virus), hoping that, like the previous epidemics, this summer will considerably reduce the rate of expansion and incident of the virus which has now gotten out of control. And at the same time, as with any viral epidemic, the world is turning to biotechnology companies to find a solution. Such a solution can be in the form of a drug or a vaccine. Large biotechnology companies have already successfully disseminated information and solutions, even on the most serious viral diseases that were considered to be incurable.
These days, huge efforts are being made, both by large companies and by startups, to find a solution to the corona virus in the form of a remedy or a vaccine. These efforts are supported by various American and European authorities, including BARDA and NIAID and CEPI through funding.
So first of all, in order not to confuse us, a few words: On February 11, 2020, the World Health Organization (WHO) announced a new name for the “coronavirus” disease in the current pandemic: Coronavirus Disease 2019 COVID-19. International viral taxonomy has decided on SARS-CoV-2, officially recognizing this virus as a “member” of the family of corona viruses which causes an acute respiratory syndrome like MERS and SARS. COVID19 and SARSCoV2 are the official names of the disease and the virus. In this review, the term “corona virus” will be used.
There are eight other companies that are developing “corona virus” drugs or vaccines.
In this section, we will review a drug, Gildes Sciences Remdesivir and President Daniel O’Day. Gilead Sciences works against the treatment of hepatitis C, as well as drugs for the treatment of HIV and even Truvada for the prevention of HIV.
In late February 2020, Bruce Eilruad, senior adviser to the World Health Organization, noted that there is a remedy that they believe has a realistic chance of being effective, which is Remdesivir. It is an investigational antiviral drug that was developed against Ebola and is currently being researched and tested against the Corona virus. Today, there are clinical trials in the United States, China and soon in other Asian countries where there are a large number of people infected with the virus. Preliminary results of the first tests are expected by April 2020.
Principle of action of Remdesivir: the drug was designed to slow the infection of healthy cells by blocking the replication of the virus and impairing its ability to use the body’s cellular mechanics to replicate during virus epidemics. Initial animal studies have shown the drug to be effective against Ebola, prompting Gilead to start a phase 1 trial and expand it later.
However, a phase 3 trial in Congo has shown that the drug is less effective at preventing death from the Ebola virus than two other competing drugs. The epidemic of corona virus has raised the possibility that the drug may be effective, but what evidence indicates that Remdesivir can treat and treat patients with coronavirus?
Initially, the company had preclinical data showing that this drug is active against the MERS and SARS viruses (the previous generators of epidemics of corona virus) which share enough genetic similarities with the corona virus which causes the current epidemic of a way researchers and society believe Remdesivir could work against this virus as well.
Tests by researchers at the National Institutes of Health published in January of this year showed that the drug prevented MERS from developing in monkeys and helped improve the condition of already infected animals.
Recently, a laboratory study by scientists at the Van Virology Institute found that remdesivir and another antimalarial drug called chloroquine are more likely to be effective against Corona virus (SARS-CoV-2 than other potential treatments tested ).
Many focused on the treatment of the Washington patient returning from Wuhan and found positive for the Corona virus. Doctors gave him the drug after a week of treatment, and his condition improved a day after the drug was administered. However, it is not demonstrated whether it is attributable to the effectiveness of the drug, since the viral load (the digital expression of a given amount of virus) in this patient began to decrease the day before of the drug.
The first clinical trial in the United States to assess the efficacy and safety of the broad-spectrum antiviral drug Remdesivir for the treatment of coronary artery disease has started at the University of Nebraska Medical Center (UNMC) in Omaha, Nebraska.
This is a randomized, double-blind, placebo-controlled phase 3 trial for patients with confirmed Corona virus infection with symptoms. People with a mild infection will not be included in the study.
In addition, on March 3, 2020, GILEAD announced that the US FDA was rapidly considering its request to test Remdesivir for the treatment of corona virus. The company has started two phase 3 clinical studies to assess the safety and efficacy of Remdesivir in adults diagnosed with the disease. These are randomized, open, multicenter studies in which around 1,000 patients are enrolled in medical centers mainly in Asian countries, as well as in other countries of the world with multiple diagnoses, starting in March. The studies will examine two intravenous doses of Remdesivir. Experimental results are expected in May 2020.
The first of two studies will assess the safety and efficacy of a 5-day regimen and a 10-day intravenous dose of Remdesivir in patients with severe manifestations of the disease (COVID-19). About 400 participants will participate in the experience.
The second study will assess the safety and efficacy of a 5-day and 10-day regimen of intravenous Remdesivir in patients with moderate manifestations of the disease compared to the existing standard of treatment. The trial will include approximately 600 participants.
Remdesivir is given as “compassionate care” (which is the use of a new medicine, which has not yet been approved, to treat patients with serious illnesses when no other treatment is available) . In Israel, Remdesivir in combination with chloroquine (the antidote for malaria) was administered to patient number 16 hospitalized in Poria, where his condition improved. Following his treatment, the hospital said in recent days: “The condition of patient No. 16, the first tourist bus driver in Corona who was in serious condition (since 4.3), improved during the night , he is now breathing on his own. Today, this patient has returned home.
To date, there are some encouraging signs, but there are still many question marks. Also for Ebola, preclinical information indicated that the drug had potential, but the results of phase 3 were disappointing. Even if the drug proves useful in one of the trials, the exact dosage, the exact treatment period, the exact symptoms justifying its administration, etc. will have to be found later. Of course, if the experiment works, society will have to prepare for massive drug production. In this regard, the company has indicated that it is investing heavily in its supply chain, so that if the trials are successful, the company will be able to react quickly.
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