Arcturus' COVID-19 mRNA Vaccine Candidate To Target Variants, Trial To Start In Vietnam

The Vietnam Ministry of Health has signed off Arcturus Therapeutics Holdings Inc's ARCT Clinical Trial Application (CTA) to advance ARCT-154 COVID19 vaccine candidate targeting variants of concern.
The ARCT-154 Phase 1/2/3 clinical study is a randomized, observer-blind, placebo-controlled design and is sponsored and entirely funded by Arcturus' manufacturing partner Vinbiocare, a subsidiary of Vingroup.
The study will assess the safety, immunogenicity, and efficacy of the SARS-CoV-2 self-amplifying mRNA vaccine in adults 18 years or older and enroll up to 21,000 participants across the 3 phases, with 20,000 in Phase 3.
Primary endpoints include safety and efficacy with immunogenicity being evaluated in a subgroup.
If the study proves successful at interim evaluations, Emergency Use Approval (EUA) by the Vietnam Ministry of Health is anticipated in December 2021.
Vinbiocare and Arcturus also announced to establish a manufacturing plant for the COVID-19 vaccines.
Price Action: ARCT shares are up 9.10% at $34.16 during the market session on the last check Monday.
Related content: Benzinga's Full FDA Calendar.