Benzinga | Aug 2, 2021 11:22AM EDT

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 (NASDAQ: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.