"We do not expect serious side effects": Director of the Institute of Immunology - on the drug for the treatment of coronavirus "MIR-19", by Ekaterina Kiyko for RT Rússia. 01/09/2021.
In Russia, the second stage of clinical trials of the drug for the treatment of coronavirus "MIR-19" is coming to an end. Musa Khaitov, director of the Institute of Immunology of the Federal Medical and Biological Agency of Russia, spoke about this in an interview with RT. According to him, during the first two stages of the study, the safety of the drug was demonstrated. Experts expect that MIR-19 will be intended for patients of all ages. The immunologist added that work is now underway to create an industrial technology for the production of the drug, so that after registration it will be available to as many Russians as possible.
What is the mechanism of action of the drug "MIR-19"? What are its main characteristics?
"MIR-19" is a unique etiotropic antiviral drug that acts directly on the SARS-CoV-2 virus that causes COVID-19. It was created in such a way that its active component is the so-called small interfering RNAs. Therefore, the drug is called "MIR-19", this is an abbreviation ... This RNA is aimed at a certain conserved part of the genome of the SARS-CoV-2 virus, which, after interaction, undergoes certain modifications and thus is effectively removed from the infected cell.
The main entrance gate of infection is the upper respiratory tract. The virus multiplies in the epithelium of the upper and lower respiratory tract. We need to suppress its reproduction. Therefore, inhalation was tested and it was proved that this is the most effective way of delivering the drug and so it will be able to most effectively implement its antiviral activity.
Why have no effective drugs against coronavirus been created in the world until today?
The fact is that the creation of a drug is a very long process. You need to understand that this takes years, and maybe decades. A little more than a year and a half has passed since the beginning of the epidemic. And accordingly, the leading scientific teams of the world began to develop drugs against SARS-CoV-2 almost a year and a half ago. Therefore, today a very large number of candidate drugs are at various stages of development all over the world.
With the drug "MIR-19" in just over a year and a half we managed to go through this very difficult path: from the idea of developing the drug itself to the second phase of clinical trials. This became possible thanks to the colossal work of our team at the Institute of Immunology, as well as our partners - the St. Petersburg Institute of Vaccines and Serums.
Have you already published an article about the effectiveness of your drug in international peer-reviewed journals? Are you planning any other publications on the efficacy, safety of the drug and the last stage of trials?
In April of this year, we published an article in Allergy magazine. It is by far the world's leading journal of clinical immunology. In it, for the first time in the world, we demonstrated the possibility of creating an antiviral drug against SARS-CoV-2 based on small interfering RNAs. Of course, after the completion of the second phase of clinical trials and registration of the drug, we will publish the data in a serious international scientific publication.
Does the drug "MIR-19" have analogues?
There are no registered analogues. The drug is absolutely unique.
In your last interview with RT, you mentioned that the drug is absolutely safe. To date, have not been identified any side effects? Will the drug be indicated for all age groups?
The drug has gone through a full cycle of preclinical studies, where it was demonstrated that it is safe and belongs to the class of low-toxic compounds. Based on this, we received permission from the Ministry of Health to conduct the first phase of clinical trials, where safety is checked in healthy volunteers. The safety of the drug has been confirmed.
Today we are conducting the second phase of clinical trials, where its safety will be confirmed already in patients with coronavirus. Considering the mechanism of action of the drug and the results that we received during preclinical studies and in the first phase, we do not expect any serious side effects from it. I would very much like to hope that it will be available to both elderly patients and the smallest children.
Will MIR-19 be used only for the treatment of COVID-19? Or will it be able to form immunity against coronavirus infection, like a vaccine?
The fact is that MIR-19 is a drug, that is, it is not capable of forming immunity, like vaccines. It can lead to a decrease in viral load in a person who has contracted the coronavirus. Accordingly, a person recovers much faster by taking this drug.
In September, you are going to submit documents to the Ministry of Health for registration of the drug. Do you currently have a project for the production of the first doses of the drug, how much do you plan to release?
The second phase of clinical trials of the drug is now coming to an end. After submitting the report to the regulator, we will initiate the registration procedure. First of all, the drug will be available in hospitals, that is, those patients who need it most. Now we are very actively working on scaling up, on creating industrial technology, so that in the future the drug, of course, will be available to all segments of the population.
Are there already requests for the use of the drug "MIR-19" from foreign countries?
Yes, there is interest. In particular, representatives of pharmaceutical companies from Japan and South Korea contacted me with letters. It is planned to export the drug to other countries. I would like to help as many people as possible who can potentially get coronavirus.