Posted 23 декабря 2021,, 12:41

Published 23 декабря 2021,, 12:41

Modified 24 декабря 2022,, 22:37

Updated 24 декабря 2022,, 22:37

New cure for coronavirus "Mir-19": it helped hamsters, people are next in line

New cure for coronavirus "Mir-19": it helped hamsters, people are next in line

23 декабря 2021, 12:41
Russia has released the drug Mir-19, which is capable of suppressing the development of the Covid-19 virus. It was developed on the basis of the Federal Biomedical Agency and may appear in pharmacies by this summer.
Сюжет
Pandemic

Irina Mishina

Mir-19 announced as a "new generation" drug

It has no analogues. The developer claims that the vaccine is based on the use of micro-RNAs that block certain parts of the virus. Thus, the drug effectively attacks viruses, but does not affect the human genome or immunity. The developers believe that the drug is effective against all known strains of Covid-19.

Treatments for covid have changed many times since the pandemic began. The Ministry of Health has updated its protocols 13 times, each time supplementing and changing them. But the end of the pandemic is not in sight, the curves of infection and mortality continue to creep upward. And these protocols are controversial again. While in the Kommunarka covid department, for several days I drank Coronavir, 8 tablets a day, plus other drugs and droppers. But this did not save me from a difficult course. It did not save me from complications, which I have to deal with for almost a year.

What is new in the treatment of coronavirus offered to us today?

Little is known about Mir-19. A sparse official statement says that the drug has passed the second phase of clinical trials. It is also known that this drug is intended for the prevention or treatment of coronavirus infection through inhalation or intranasal administration. Mir-19 is inhaled using an inhaler through a mask. According to the developers, no side effects were found in the drug. At the Institute of Immunology, we were told that MIR-19 is based on a mechanism similar to that which is used inside human cells to turn off internal processes. For this, several nucleotide sequences were selected that chemically bind to the three genes of the virus. Thus, the SARS-CoV-2 gene is blocked. In cell culture, the drug inhibited viral replication by almost 10 thousand times. In experiments on hamsters, the drug significantly suppressed the replication of the virus in the lungs, the developers say.

For a coronavirus drug to be marketed and used in treatment protocols, not only clinical research is needed, but also consumer confidence. We all know widely advertised drugs, which were positioned by pharmaceutical companies as a panacea for covid. The demand for them was quite high, despite the high cost, but, alas, they could not reverse the situation with the epidemic. The excitement around them quickly faded away, and serious research began. Therefore, manufacturers are in no hurry to release Mir-19.

“Everything will depend on the effectiveness of the drug and on the epidemiological situation. Accordingly, we will not see the results soon, sometime by the summer, ”said Sergei Shulyak, General Director of DSM Group, an analytical company for the pharmaceutical market.

We also made a request to the Federal Biomedical Agency with a request to inform about the timing of the release of the drug "Mir-19", but did not receive a definite answer at the time of publication.

There are two phases of clinical trials, but their results are not known

“Small interfering RNA preparations, which Mir-19 is, are already being used in clinical practice, mainly for the treatment of rare diseases. Of course, the development of such drugs is difficult due to the complexity of the delivery of RNA into the body and their protection from the immune response. There is still little data on the drug - only one article with experimental data has been published. There are two phases of clinical trials, but there are practically no publications of their results. So for now we are looking forward to the publication of the results of clinical trials in leading world scientific journals, as was the case with Sputnik in The Lancet , ”David Naimzada, a researcher at the Laboratory for Analysis of Population Health Indicators and Digitalization of Healthcare at MIPT , told NI.

The attitude of foreign scientists to the Russian drug is still quite skeptical. Why do Russian scientists and physicians pin such high hopes on him for a turning point in the situation with Covid-19?

“Experiments with Mir-19 were carried out on Syrian hamsters. They were given the drug intranasally. It was reported that there was a fairly frequent introduction of the aerosol, several times a day. Judging by the results, the new drug significantly reduced the titer of viral bodies. At least compared to Favipiravir. In comparison with it, the viral load in animals was lower, and there was also a change in the lung tissues for the better. But today there is no publicly available data on the use of Mir-19. It is only known that, according to the research results, the use of Mir-19 helped to overcome the viral load in hamsters, but did not completely cure them , "said David Naimzada, a researcher at the laboratory for analysis of population health indicators and digitalization of health care at MIPT, to NI.

Most of the experts with whom we were able to talk about the new Russian drug agree that it is the best fit for the initial stage of the disease, when it is important to stop the development of the virus.

“The mucous membranes of the nose are the gateway for the virus, through which it enters the body and develops there. Injections are a rather complex mechanism to deliver the active substance to the cell. Mir-19 prevents the penetration of the virus into the body. That is, it does not kill the virus at all, but worsens the conditions for its stay in the body. This is, so to speak, the first echelon of defense against the virus. But if the virus does enter the body, another new drug can help. It is developed by Pfizer and is called Paxlovid. It is he who helps the immune system to produce cells that can generate antibodies to destroy the virus, ” Larisa Popovich, Director of the Institute for Health Economics at the Higher School of Economics , told NI.

Mir-19 and developments of foreign companies

Indeed, the American company Pfizer has completed the second phase of clinical trials of a new drug against coronavirus, which is called Paxlovid. This happened almost simultaneously with the reports about the release of the Russian "Mir-19".

"The analysis showed an 89% reduction in the risk of hospitalization or death [in patients] due to COVID-19 for any reason, compared to patients who received a placebo within three days of the onset of symptoms," the pharmaceutical company said in a statement. The creators of the drug claim that there were no deaths among the participants in the trials of the drug, which is taken orally. Based on the results of the trials, Pfizer announced its intention to obtain an emergency use authorization for its new drug. According to Larisa Popovich, director of the Institute for Health Economics at the Higher School of Economics, the combination of these two drugs - Mir-19 and Paxlovid - could be very effective and, possibly, turn the tide with the pandemic.

However, some researchers on coronavirus treatments are skeptical about both drugs. Apparently, this is due to the negative experience of using widely advertised drugs from the recent past.

Mir-19 is an etiotropic drug based on blocking the gene that is responsible for the production of polymerase. The same method is at the heart of Remdesivir, a new American antiviral drug. It was widely advertised, went on sale in more than 50 countries, but in the end, according to the results of WHO research, it was recognized as not very effective. Quite simply, it didn't work. But the price for it went off scale. As for Paxlovid, it is an interesting enzyme inhibitor drug. But about the same action is at the heart of Ivermectin, which costs a penny. Aren't we dealing with pharmaceutical companies again? " , - says biologist, researcher of methods of treating coronavirus Veniamin Zaitsev-Friedshtand.

Treatment with monoclonal bodies

In addition to Mir-19 and the drug Paxlovid, another method of treating coronavirus is now being tested in Russia - treatment with monoclonal bodies. The Moscow City Clinical Hospital No. 52 has a great practice in this. The drug based on monoclonal antibodies, the action of which is directed to the S-protein of the coronavirus, is administered once intravenously using a dropper. It works in a similar way to the antibodies that the immune system makes to fight infection. In patients at risk, it is important to start using the drug as early as possible in order to help the body fight the virus in time and prevent complications. The selection of patients for such therapy is carried out according to special criteria. Among the main ones are severe concomitant diseases.

We turned to the 52nd Moscow City Hospital for clarifications. We were told that the treatment of covid by means of monoclonal bodies is quite expensive, but in this hospital it is available under compulsory medical insurance. But strictly for certain groups: these are patients with diabetes mellitus, after organ transplantation, with severe kidney disease, with cancer.

“Monoclonal bodies are injected when a person's own immune system fails. Most often, these droppers are given to terminal, hopeless patients. Here, the approach to everyone is purely individual, so therapy is expensive. The introduction of these monoclonal bodies is effective only in the early stages of the disease , ”explained Larisa Popovich, Director of the Institute for Health Economics at the Higher School of Economics.

However, as we managed to find out, it is possible to introduce monoclonal bodies not only to seriously ill patients. This can be done for a lot of money. So, in private clinics in Moscow, one such dropper with a special team's visit to the house will cost from 230 to 270 thousand rubles. Of course, no one is responsible for the effect.

New drugs for coronavirus infection are certainly hope for the best. But it's worth remembering that any serious drug undergoes clinical trials for 5 to 10 years. Moreover, not only on animals, but also in focus groups on humans. Of course, in a pandemic, time is short; in urgent cases, the process can be accelerated. The main thing is that there should be a result that all of us, who have been ill and are afraid of this, who survived lockdowns and restrictive measures, have long deserved.

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