RDIF and ChemRar Announce First Interim Results of Clinical Trials of Favipiravir Drug's Effectiveness in Coronavirus Therapy
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."
Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF's management company is based in Moscow. Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totaling more than RUB1.8 tn and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia's GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 15 countries that total more than $40 bn.
RDIF takes active steps to counteract COVID-19:
- RDIF and partners have launched the production of the unique Russian-Japanese EMG diagnostic system, which generates results in 30 minutes with an accuracy of more than 99.9% in both stationary and unmatched portable mini-laboratories. The Japan Bank for International Cooperation has joined the project through the Russia-Japan Investment Fund. Home-testing for coronavirus has been launched in partnership with Yandex;
- RDIF and the ChemRar Group have produced the first batch of Favipiravir, a drug that has proven effective in the treatment of infected patients in China and in clinical trials in Russia. Preparations are currently underway for the mass production of the drug;
- RDIF has launched a project to diagnose and detect pneumonia, including that caused by coronavirus, using CT scans combined with the Russian-UAE artificial intelligence (AI) technology developed jointly by Group 42 (G42), RDIF and Medscan Group;
- RDIF has provided support to the public in observing the lockdown restrictions and self-isolation regime, driving a several-fold increase in telemedicine consultations via the Doctis service, as well as in access and subscriptions to the ivi online media library, delivery of Elementaree meal kits and demand for products and services of other RDIF portfolio companies;
- RDIF was one of the initiators of the Alliance against coronavirus, which also includes the Russian Union of Industrialists and Entrepreneurs (RUIE), Yandex, Mail.ru Group and the Rossiya Segodnya international news agency. RDIF is actively involved in key initiatives and charity projects.
Further information can be found at www.rdif.ru
ChemRar Group unites R&D service and investment companies in the field of innovative pharmaceuticals for the development and commercialization of innovative medicines, diagnostics, preventive care and new treatments of life-threatening diseases in Russia and abroad. Further information can be found at http://en.chemrar.ru/
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