Japan's Chugai Pharmaceutical Co., Ltd. announced today that it has reached a licensing agreement with Roche to develop and market a new oral anti-COVID-19 candidate drug, AT-527, in Japan.
AT-527 is a research oral pyrethroid nucleotide pre-drug that has been shown to have antiviral activity in vitro and in vivo for several single-stranded RNA viruses, including human yellow and coronavirus.
this highly selective pre-nucleotide drug is designed to uniquely inhibit viral RNA-dependent RNA polymerases, an enzyme essential for replicating RNA viruses.
activity and safety of AT-527 has been confirmed in Phase II clinical studies in patients with hepatitis C and in preclinical testing of SARS-CoV2 virus.
note that the AT-527 has not been licensed or approved for any use in any country.
developed the AT-527 in partnership with Roche and Atea.
approval, Atea will distribute the AT-527 in the United States, while Roche will be responsible for global manufacturing and distribution outside the United States.
under a licensing agreement between Roche and Chugai Pharmaceuticals, Chugai Pharmaceuticals acquired exclusive development and sales rights for the AT-527 in Japan.
, phase II clinical studies are being conducted in patients requiring hospitalization in moderate COVID-19 and mild to moderate COVID-19 patients who are not hospitalized.
is expected to begin a Phase III clinical study in the first half of 2021 to assess the efficacy and safety of AT-527 in patients with mild or moderate COVID-19.
Osamu Okuda, president and chief operating officer of Chugai, said: "COVID-19 has not shown signs of slowing down and new treatment options are still needed."