02 June 2021

Against the cytokine storm

A drug for the treatment and prevention of lung lesions of a viral nature, developed by the FMBA of Russia, has been registered

FMBA Press Center

On May 25, the inhalation drug "Leitragin", developed at the Federal Biomedical Agency, was registered by the Ministry of Health of the Russian Federation. The new drug is intended for the treatment and prevention of pneumonia, complicating the course of a new coronavirus infection (COVID-19).

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"Clinical studies have confirmed the effective preventive effect of Leutragine against respiratory viral infections, primarily caused by SARS-CoV-2. This allows us to understand now the direction of our further post-registration studies of the drug for the treatment of new dangerous diseases," said Veronika Skvortsova, head of the FMBA of Russia.

Leitragin is the first representative of a new class of medicines aimed at preventing and combating the cytokine storm that aggravates the course of coronavirus infection. Cytokine storm precedes the occurrence of acute respiratory distress syndrome, multiple organ failure, as well as disorders of blood clotting properties, which are the main causes of mortality in COVID-19. Therefore, the fight against cytokine storm is of particular importance for the treatment of patients with COVID-19.

The fundamental difference between Leutragine and other anti-cytokine drugs that suppress individual cytokines is that Leutragine safely suppresses the release of many cytokines and other inflammatory mediators, affecting several major signaling pathways in the immune system at once. In addition, the use of Leutragine is characterized by the absence of undesirable side effects, unlike other anti-cytokine drugs used to treat COVID-19.

"From March to June 2020, the Scientific Center for Biomedical Technologies of the FMBA of Russia worked intensively, almost around the clock. The head of the Agency Veronika Skvortsova was tasked with developing new effective approaches to the treatment of patients with COVID-19. The Institute managed to develop a non-infectious model of acute respiratory distress syndrome in mice in the shortest possible time. This syndrome is one of the main causes of death in coronavirus infection. Screening of a variety of candidate molecules for its prevention and relief was carried out and the most effective and safe means were selected. Since April 15, 2020, clinical studies of Leitragin have been launched, which were conducted in several scientific and clinical centers of the FMBA of Russia. Studies have confirmed the high efficacy and safety of the use of this drug in patients with pneumonia with COVID-19 compared with standard therapy," said Vladislav Karkishchenko, director of the Scientific Center for Biomedical Technologies of the FMBA of Russia.

In the course of studies involving 320 patients with a moderate course of a new coronavirus infection, it was found that in the group of patients treated with Leutragine, there were not only no deaths, but there were no cases of the disease passing into a more severe form. At the same time, the recovery time of patients receiving Leutragine was reduced to 8 days compared to 14 days in the control group receiving standard therapy.

Leitragin is an original domestic medicinal product with a full technological cycle of production on the territory of the Russian Federation. The drug has been patented by the FMBA of Russia and its industrial production is currently beginning.

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