PROMOMED has started research on an innovative drug for the treatment of influenza

PROMOMED Company has received permission[1] to conduct a clinical trial of the bioequivalence of the antiviral drug with the international nonproprietary name (INN) baloxavir marboxil. Baloxavir marboxil is a modern antiviral drug for the treatment of influenza A and B with a new mechanism of action, which is so important during the selection of individual therapy taking into account the mutation of the virus. The drug suppresses the early stage of virus reproduction and thereby helps to stop its replication. Only an imported drug with this active ingredient is registered in our country. PROMOMED, as part of its systematic work on import substitution, has completed the full development cycle of baloxavir marboxil for the first time in Russia.

The study aims to evaluate the pharmacokinetics and bioequivalence of the drug with INN baloxavir marboxil in comparison with the reference drug Xoflusa®. The project involves the participation of 24 healthy volunteers. The main purpose of the study is to compare the key pharmacokinetic parameters of the tested and reference drugs in order to confirm their bioequivalence in a controlled clinical trial. The study is planned to be conducted on the basis of LLC "Scientific Research Center Eco-safety" (St. Petersburg). The work is expected to be completed in March 2027. The decision to launch the commercial sale of the drug with INN baloxavir marboxil can be made by PROMOMED only taking into account the necessary legal conditions.

Neuraminidase inhibitors are widely used in the treatment of influenza: they mainly prevent the release of already formed viral particles from the infected cell. Baloxavir acts earlier, at the stage when the virus only "turns on" the production of its components inside the cell. Once in the cell, the influenza virus must begin synthesizing its own viral RNAs and proteins. To do this, it uses a special technique: it "borrows" a short starting fragment from the cell with a protective "cap" at the end of the RNA molecule (this process is called cap-snatching, or "cap capture"). After that, the assembly of the virus' own RNAs begins. Baloxavir selectively blocks the viral enzyme that is responsible for this "slice" of the starting fragment. When the enzyme is suppressed, the virus loses the ability to normally start the synthesis of its RNAs. As a result, the formation of viral proteins and new viral particles decreases, the viral load decreases and the spread of infection in the body slows down.

"For PROMOMED, the launch of a clinical trial of an antiviral drug with INN baloxavir marboxil is an important step in strengthening its own competencies in developing innovative molecules for the country," said Victoria Shcherbakova, PROMOMED Medical Director.
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[1] https://grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=cb5ad49d-05c3-454a-922b-92c7b1b6a3...
[2] https://iz.ru/2105980/irina-ionina-alina-odoeva/v-rossii-zavershilas-ehpidemiya-grippa-i-orvi
[3] https://www.who.int/ru/news-room/fact-sheets/detail/influenza-%28seasonal%29