Daiichi Sankyo Company, Limited today announced that it has initiated in Japan a first-in-human phase 1 trial for nafamostat inhalation formulation (DS-2319), which is being developed as a potential medicine for the treatment of the novel coronavirus infectious disease (hereinafter, COVID-19).
DS-2319 contains nafamostat mesilate (hereinafter, nafamostat) that has been formulated in an inhalation dosage form. It is being studied for treating COVID-19 since it has been shown to block membrane fusion between the viral envelope that causes COVID-19 and the host plasma cell membrane. Nafamostat has been available as an injection for treating acute pancreatitis and disseminated intravascular coagulation in Japan for many years, and there is acceptable clinical data on its safety.
This first-in-human phase 1 study involving healthy adults will evaluate the safety, tolerability, and pharmacokinetics of DS-2319 when given as a single dose or as multiple doses through inhalation.
By pursuing the development of DS-2319, Daiichi Sankyo hopes to deliver a new therapeutic option to patients with COVID-19 as soon as possible.