MOSCOW — The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and the ChemRar Group Wednesday announced a positive first interim results of the multicenter randomized open comparative clinical trial of the drug Favipiravir on patients hospitalized with COVID-19.

According to the data received, 60% of the 40 patients who took Favipiravir have tested negative for coronavirus after five days of treatment, which is two times higher than in the standard therapy group. The data is consistent with the results of studies conducted in China, which also showed a reduction in the disease duration from 11 days to 4-5 days.

Six leading medical centers in Moscow, Smolensk and Nizhny Novgorod are currently participating in clinical trials, including I.M. Sechenov First Moscow State Medical University, Lomonosov Moscow State University and the Central Clinical Hospital. In total, 30 medical centers in 8 Russian regions will conduct studies on 330 patients with confirmed coronavirus infection.

The next important step is to obtain a registration certificate for the possible use of Favipiravir countrywide. The ChemRar Group alongside RDIF will be able to start commercial deliveries of the drug as soon as the end of May. The necessary reagents are available and production facilities are ready to start commercial production.

The advantages of Favipiravir include a significant reduction in the patients’ recovery time and their infectiousness, as well as the drug’s availability in tablets, which makes it easier to use. Regulators and experts will be able to monitor the safety of using Favipiravir online as a special system for post-registration monitoring is being developed for them.

The start of the drug production in Russia will make a significant contribution to ensuring the country’s biological security and uninterrupted supply of the medicine to Russia's regions.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: “The first positive results of the trial will facilitate an accelerated permission from the Ministry of Health of the Russian Federation to start using the drug, which will enable treatment of patients with Favipiravir across Russia's regions.

“The use of the drug will help reduce the length of stay in a hospital for patients infected with COVID-19 and the need for opening new hospitals. Two hundred and fifty treatment courses of the drug have already been produced, while another 1,500 courses are currently at the production stage.

“Production lines have been established in cooperation with the ChemRar Group for the production of up to 600,000 courses per year. Once the clinical trials and registration procedures for Favipiravir are completed, Russia will become one of the few countries in the world that independently manufacture a coronavirus drug and will be able to guarantee its reliable supply to medical institutions.”

Elena Yakubova, CEO of ChemRar Pharma, said: “The Safety Council has held a meeting today as part of the clinical trial of Favipiravir. Independent experts discussed the effectiveness of the first five days of the therapy and confirmed the sufficient safety and tolerability of the drug, as well as recommending continued clinical trial. We are actively opening additional medical centers in Moscow and other Russian cities, but as part of the trial we can cover a limited number of patients.

“Given the urgent need to provide access to highly effective treatment for a greater number of patients with the coronavirus infection and supply the drug to medical facilities across Russia, we hope that the Ministry of Health will support the possibility of a temporary registration of Favipiravir under a fast-track mechanism in accordance with the Decree of the Government of the Russian Federation of April 3, 2020 No. 441”. — SG