New antiviral drug that could prevent COVID-19 infection enters phase III

In addition to developing vaccines against COVID-19, laboratories and university scientists are working on the development of effective drugs to treat the disease, from those that generate immunity to those that are used to treat its moderate and severe forms.

Along this path, a drug that has been in the experimental stage since last year to prevent COVID-19, showed a series of positive results in a preliminary study, published in the prestigious journal Nature Microbiology last December by researchers at the University of Georgia, Atlanta. The Merck Sharp & Dohme laboratory (Merck & Co in the United States and Canada) Iis carrying out an in-depth study on this subject.

On December 3, Drs Robert M. Cox, Josef D. Wolf and Richard K. Plemper, of the Institute of Biomedical Sciences of Georgia State University, USA, had published the scientific study on molnupiravir, the drug that promises to stop infections within 24 hours.

Now a new step will come, since in the last hours, Merck (MSD) and Ridgeback Biotherapeutics announced the start of Move-Ahead Phase 3 Clinical Trial evaluate the drug molnupiravir. It is oral antiviral therapy for prevention of COVID-19 infection. The study will be conducted in people over the age of 18 who reside in the same household as a person with symptoms of coronavirus and who has tested positive for SARS-CoV-2.

MSD Research Laboratories Senior Vice-President Vaccines, Infectious Diseases and Clinical Research, Nick kartsonis, said that “as the pandemic continues to evolve and epidemics are reported in many parts of the world, It is important that we explore new ways to protect people exposed to the virus from infection with symptomatic disease. He added that, if the drug is successful, “it could provide an important additional option for reduce the burden of COVID-19 in our communities”.

From MSD, they said that “the safety and effectiveness of molnupiravir is also being evaluated in the Trial move, part 2, an ongoing, global, Phase 3, randomized, placebo-controlled, double-blind, multicenter study in out-of-hospital adult patients with laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with adverse disease outcomes ”.

The Move-Ahead trial (MK-4482-013) (NCT04939428) will include more than 1330 participants, who will receive 800 mg of molnupiravir or placebo orally every 12 hours for five days. Excluded from the study are people who received a dose of the COVID-19 vaccine more than a week ago, had previously had the disease or had symptoms of coronavirus.

Countries around the world will participate in the trial, including Argentina, Spain, Brazil, Colombia, France, Guatemala, Hungary, Japan, Mexico, Peru, Philippines, Romania, Russia, South Africa, Turkey, Ukraine and United States They will also be part of the study.

Molnupiravir is an antiviral drug with the technical name MK-4482 / EIDD-2801, and it is a ribonucleoside inhibitor which is administered orally. In principle, It was designed to treat influenza and prevent the virus from reproducing itself, creating errors during viral RNA replication. If treatment is started on time, those infected could gain great benefits for themselves and for the rest of society, as the drug could prevent the patient from becoming severe, shorten their infection, and prevent community outbreaks.

“This is the first demonstration of an orally available drug to rapidly block the transmission of SARS-CoV-2,” Plemper said. According to the publication in the scientific journal, This antiviral drug could prevent carriers of the virus from developing severe symptoms and transmitting the disease, as well as containing local outbreaks “in one day”.

Since the drug can be taken orally, treatment can be started early for a triple potential benefit: inhibit the progression of patients to severe disease, shorten the infectious phase to alleviate the emotional and socio-economic cost of prolonged patient isolation, and rapidly reduce local epidemics.

“We have observed from the beginning that MK-4482 / EIDD-2801 has broad spectrum activity against respiratory RNA viruses and that oral treatment of animals infected with the drug reduces the number of viral particles spread by several orders of magnitude, which drastically reduces transmission, ”said the Plemper. “These properties made MK-4482 / EIDD / 2801 a strong candidate for pharmacological control of COVID-19,” said Plamper who used a ferret model to test the drug’s effect in stopping the spread of the virus.

“We believe ferrets are a relevant transmission model because they easily spread SARS-CoV-2, but for the most part they do not develop serious disease, which se closely resembles the spread of SARS-CoV-2 in young adults ”, said Dr Robert Cox, Plemper Group postdoctoral fellow and co-lead author of the study.

In the first step of the study, the researchers infected ferrets with SARS-CoV-2 and began treatment with MK-4482 / EIDD-2801 when the animals started shedding the virus through their noses. “When we shared the infected animals and then treated the source animals with untreated contact ferrets in the same cage, none of the contacts became infected.Said Josef Wolf, a PhD student at Plemper’s lab and co-lead author of the study. In comparison, all contacts of the original ferrets that received the placebo became infected. If this ferret-based data is translated into humans, COVID-19 patients treated with the drug could become non-infectious within 24 hours of starting treatment, according to the study funded by public health service grants institutes. Institute of Allergies and Infectious Diseases.

MK-4482 / EIDD-2801, which taken in three different doses every 12 hours for five days in COVID-19 patients it also has broad-spectrum activity against other respiratory RNA viruses, reducing the number of viral particles spread by orders of magnitude, significantly slowing transmission, scientists say.

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