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The laboratory Pfizer could have for end of year nail coronavirus pill. The antiviral drug, called PF-07321332, could be administered for prevent the disease from getting worse in those who have the first symptoms. According to the newspaper The telegraph, the pill could be ready before 2022 if the ongoing human trials in the United States and Belgium are successful.
The drug currently is in phase 1 clinical trials involving around 60 people – all adults aged 18 to 60 – and It should end this May 25. Once finished, if the pill is found to be safe, more people will be tested to see if the drug actually works against covid-19, as suggested by the first lab tests.
The trial is divided into three phases in total to be developed over 145 days, to which will be added another 28 “screening and assay”. Phase 1 is designed to see “how it is tolerated when the dose is increased, alone or with ritonavir, if there are any significant side effects and how people feel after taking it ”.
In the second step, the same will be done but with “multiple doses”, while in the last liquid and pill forms of the drug will be tested, as well as the impact of diet on the drug, according to the document that was given to the test volunteers, and to which he had access The telegraph.
“The safety of the study drug has been studied in animals. In these animal studies, no significant risks or safety events of concern were identified, and the study drug did not cause any side effects at any of the dose levels that will be used in clinical studies, ”says the document.
PF-07321332 will be administered in combination with low dose ritonavir, an antiviral used to treat HIV. It acts as a “booster” to increase the amount of PF-07321332 in the blood of participants.
“We designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without patients being hospitalized or in intensive care,” explained Mikael Dolsten, Scientific Director and President of Research, Development and Pfizer’s Global Medicine, in an official statement released last month.
The pill, classified as a “protease inhibitor”, would act on the SARS-CoV-2 spike protein and prevent the virus from replicating in the nose, throat and lungs.
However, specialists point out that the process of producing and marketing a new drug is difficult and that even though the pill is well tolerated by humans, further testing should be done to determine its effectiveness in people with coronavirus.
“If they have reached this stage, they will be quietly optimistic,” said Penny Ward, visiting professor of pharmaceutical medicine at King’s College London and a pioneer in the development of Tamiflu, an antiviral that fights seasonal and pandemic influenza. “The question will be how the drug is tolerated …”, he warned.
According to Ward, scientists at Pfizer most likely established the drug’s “potent” action by deploying it against cultures of infected human tissue, including lung tissue, in a lab. “Once we know that it works in vitro, it is a question of establishing its tolerance in animals and then in humans,” he explained.
The UK is closely monitoring Pfizer’s progress and is a major player in purchasing the pills as they become available.. Last week, Prime Minister Boris Johnson announced that a new antiviral task force would be created to find these drugs and try to make them available in the country by the fall.
“This means, for example, that if your test is positive, there might be a tablet you could take home to stop the virus and greatly reduce the risk of the infection turning into a more serious illness. Or if you live with someone who has tested positive, there may be a pill you can take for a few days to keep yourself from getting infectedThe British leader commented during a briefing in Downing Street.
Until, the only antiviral drug used in the treatment of coronavirus is Remdesivir. However, it must be injected and studies have struggled to show its effectiveness because it was not specifically designed to stop covid-19. Last year the World Health Organization (WHO) has advised against its use.
Specific therapies under development for the coronavirus include molnupiravir, from Merck and Ridgeback Biotherapeutics; tollovir, from Todos Medical; and the NT-300, from Romark. An influenza drug, favipiravir, and the HIV antivirals, ritonavir and lopinavir, are also being tested to see if they can be reused in people with coronavirus.
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