Respiratory syncytial virus (RSV) is a highly contagious human virus that infects 3-10% of the world's population every year and is the most common cause of acute lower respiratory disease in infants and young children. It is one of the main causes of lower respiratory tract infections in children under 5 years of age, bronchioles, and hospitalization for infants. There are about 34 million lower respiratory tract infections in children around the world every year, of which the death toll of children under 5 years old can reach 200,000. In addition, respiratory syncytial virus can also cause serious lung infections and death in the elderly.
AK0529 (Ziresovir) was invented after further structural optimization after cell-based high-throughput compound screening. The drug subsequently completed a comprehensive preclinical and toxicology evaluation, including toxicology studies in young animals. Ziresovir is a novel structural compound that binds to the fusion protein of the respiratory syncytial virus to prevent the virus from entering human cells and thus prevent diseases caused by infection. This fusion protein inhibitor can also achieve antiviral effects by preventing fusion between cells (i.e. forming "synocytes", the characteristic of respiratory syncytial virus infecting cells). Therefore, the mechanism of action of Ziresovir is different from the common nucleoside antiviral drugs, and will not interfere with the synthesis of nucleotide in human cells, producing mitochondrial toxicity.
iakebaifa successfully completed a global Phase II clinical study (VICTOR) in 2019. For the first time in history, an antiviral drug has therapeutic efficacy in RSV infection in hospitalized infants and young children and can bring clinical benefits to children. In this clinical trial, Ziresovir (AK0529) showed dose-related clinical effectiveness, which significantly reduced the patient's clinical signs and symptom scores while reducing the viral load in his body. The trial also confirmed a significant positive correlation between the clinical signs and symptom scores and the degree of change in viral load and Ziresovir drug concentrations. In addition, Ziresovir maintains its excellent safety characteristics among inpatient infants and young children.
AKEBYA has launched Ziresovir's Phase 4III clinical study in China , and will soon carry out a global Phase III clinical study outside mainland China; the clinical trial of this drug for adult RSV infection patients is also being promoted.
