Favipiravir and Remdesivir are entering Phase III clinical trials on COVID-19 patients.
Phase III is an enormous step because it could lead to drug approval from official health authorities.
Phase III of a clinical trial usually involves up to 3,000 participants. Selected participants have the condition that the new drug is meant to treat. The purpose of phase III is to evaluate how this new drug works. When compared to existing drugs for the same condition, The developers of Avigan (Favipiravir) have increased the production of the antiviral drug as they announced a Phase III clinical trial.
To test the safety and efficacy of the drug against COVID-19, Avigan is approved for manufacture and sale in Japan as an influenza antiviral drug.
It is manufactured by Fujifilm Toyama Chemical Co. Ltd. It selectively inhibits the RNA polymerase of the influenza virus. This enzyme is necessary for viral replication once human host cells are infected. COVID-19 uses the same enzyme to replicate and is classified into the same type of single-stranded RNA virus as influenza. Therefore, scientists believe that Avigan may be effective in treating COVID-19.
Avigan is only used if there is an outbreak of novel or re-emerging influenza virus. And that available influenza antiviral drugs are either not effective enough. Avigan’s production and distribution is controlled by Japan’s Health, Labor, and Welfare Ministry.
It has never been distributed in the market in Japan or overseas. Fujifilm said that it has already begun increasing the production of Avigan. The company is planning to co-operate with domestic and overseas partners to accelerate the production of their antiviral drugs.
The company said that it would supply the Japanese government and other countries to help them fight the COVID-19 pandemic.
Gilead Sciences has also announced that it has initiated two Phase III clinical trials. To test the safety and efficacy of Remdesivir in COVID-19 patients. Gilead Sciences will test Remdesivir in patients with moderate to severe COVID-19. The two studies were given urgent public health research (UPHR) status by the UK health authorities.
Researchers say that Remdesivir is an investigational nucleotide analog it showed broad-spectrum antiviral activity both in vitro and in animal models against different types of emerging viral pathogens.
Gilead started doing research on Remdesivir more than a decade ago. These Phase III clinical trials will help generate crucial data on the safety and efficacy of the medication. The selected sites for the Phase III clinical trials are mostly hospitals in the UK.