Daiichi Sankyo announced that the first patient has been dosed in a phase 2 trial in Japan of DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (Covid-19). This phase 2 trial is being conducted in 80 unvaccinated healthy adults using a batch of DS-5670 from the optimized manufacturing process to evaluate the safety and determine the recommended dose of DS-5670. If successful, a phase 3 trial of DS-5670 will be initiated within FY2021.

Daiichi Sankyo said it will continue discussions with the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to determine the next steps for initiating the development of a supplemental (booster) dose of DS-5670 by January 2022.

The release further added, that as a Japanese pharmaceutical company with a speciality in developing vaccines, Daiichi Sankyo will strive to help restore safety and security in society through the early eradication of Covid-19, which it hopes to achieve by pursuing the development and commercialization of DS-5670 in Japan during 2022.

DS-5670 DS-5670 is an mRNA vaccine against Covid-19 using a novel nucleic acid delivery technology discovered by Daiichi Sankyo. It is anticipated to be safe and efficacious by targeting the receptor-binding domain (RBD) of the new coronavirus. The clinical development of DS-5670 is being conducted through “Development of vaccines for the novel coronavirus disease (Covid-19) (Second Round)” (company-initiated) promoted by Japan Agency for Medical Research and Development (AMED) and “Urgent improvement project for vaccine manufacturing systems” supported by MHLW.