Russia claims promising signs in early trials of antiviral drug favipiravir (Avigan)


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MOSCOW (Reuters) – A candidate drug for treating the new coronavirus, favipiravir, has produced promising results in early clinical trials in Russia, according to the Russian Direct Investment Fund, which provided 150 million roubles ($2 million) in funding for the project.

RDIF head Kirill Dmitriev said 60% of the 40 coronavirus patients taking tablets of favipiravir, which was first developed in Japan under the name Avigan, tested negative for the virus within five days and said the treatment could cut coronavirus recovery times in half.

Drugmakers are rushing to develop treatments and vaccines for the highly contagious coronavirus that has killed over 290,000 people worldwide, infected more than 4.2 million and ravaged economies globally.

Avigan, known generically as favipiravir, was developed in the late 1990s by a company later bought by Fujifilm as it moved into healthcare. The drug works by short-circuiting the reproduction mechanism of certain RNA viruses such as influenza.

Favipiravir is also undergoing trials in India by Glenmark Pharmaceuticals Ltd.

Russia, which has the second-highest number of coronavirus cases behind the United States, is also testing vaccine prototypes on animals, while the RDIF has diverted funds to produce more tests domestically.

“This will reduce the burden on medical centres and, according to our estimates, will also reduce the number of epidemiologically dangerous patients by about 50%,” Dmitriev said, referring to a course of favipiravir treatment.

The clinical trial of 330 patients infected with the coronavirus should be finished by the end of May, said Andrei Ivashchenko, a professor at the Russian Academy of Sciences and chairman of the board of directors at ChemRar, the company conducting the trials.

“ChemRar’s existing production facilities… will allow us to produce tens of thousands of treatment programmes per month, which we estimate and hope will be enough for the Russian Federation as a minimum,” said Ivashchenko.

He said early tests showed that there were minimal side effects, although he added that pregnant women were prohibited from using it. The drug Avigan in Japan was found to cause birth defects.

Ivashchenko also said there was not enough data to say how effective the treatment would be for severely ill patients.

The World Health Organisation (WHO) sets out a four-phase overview of how clinical trials work. The trials underway in Russia would fall into the first phase of that framework.


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    Russian Direct Investment Fund (RDIF)
    13 May, 2020, 20:15 BST

    MOSCOW, May 13, 2020 /PRNewswire/ — The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and the ChemRar Group today announce the 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.”

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