Daiichi Sankyo has reported that the Phase I/II/III clinical trial of a messenger ribonucleic acid (mRNA) vaccine for Covid-19, DS-5670, as a booster met the primary endpoint.
The trial analysed the safety and efficacy of the booster dose of DS-5670.
It enrolled nearly 5,000 healthy adult and elderly participants in Japan.
These subjects had received the initial two-dose vaccine regimen with mRNA vaccines approved in the country a minimum of six months prior to enrolment.
The company commenced the trial in January this year to assess DS-5670 as a booster, with mRNA vaccines approved in the country as the control.
Geometric mean fold rise (GMFR) of neutralising antibody titer against the original SARS-CoV-2 viral strain in blood four weeks following dosing was the trial’s primary endpoint.
According to the findings, the DS-5670 booster vaccine showed non-inferiority to the other mRNA vaccines approved in the country.
No safety concerns linked to the vaccine were reported in the trial.
Based on this data, the company will advance to prepare a new drug application for the vaccine in January next year.
Daiichi Sankyo also intends to carry out trials of bivalent vaccines against the original and Omicron viral strains.
The DS-5670 vaccine has been designed to produce antibodies against the receptor binding domain (RBD) of the virus’ spike protein.
In June this year, the company reported positive findings from a Phase III trial, where its quizartinib plus standard induction and consolidation chemotherapy demonstrated to offer a statistically significant and clinically meaningful improvement in overall survival in adults with FLT3-ITD positive acute myeloid leukaemia.
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