Daiichi Sankyo Initiates Phase 1 Trial for Nafamostat Inhalation Formulation (DS-2319) in Japan

TOKYO, Japan I March 30, 2021 I Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) 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.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com/.

SOURCE: Daiichi Sankyo

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