Benzinga | Aug 2, 2021 09:03AM EDT

Arcturus Partner, Vinbiocare, Receives Clinical Trial Application From Vietnam Ministry Of Health To Advance ARCT-154

The Phase 1/2/3 trial to be funded and sponsored by Arcturus' manufacturing partner Vinbiocare

ARCT-154 to be developed in parallel with ARCT-021, Arcturus' lead investigational COVID-19 vaccine

Arcturus Therapeutics Holdings Inc. ((the "Company", "Arcturus", NASDAQ:ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, announced today that the company's partner Vinbiocare has received approval for a Clinical Trial Application (CTA) from the Vietnam Ministry of Health to advance ARCT-154, a next generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, including the Delta variant.

The ARCT-154 Phase 1/2/3 clinical study is a randomized, observer-blind, placebo-controlled design, and is sponsored and completely funded by Arcturus' manufacturing partner Vinbiocare -- a subsidiary of Vingroup, the largest private industry conglomerate in Vietnam. The study is to assess the safety, immunogenicity and efficacy of the SARS-CoV-2 self-amplifying mRNA vaccine in adults 18 years or older and will 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. Participants will receive two doses of study vaccine separated by 28 days. Placebo participants will receive active vaccine after 6 months. All participants will be followed up for 1 year. If the clinical trial proves successful at interim evaluations, Emergency Use Approval (EUA) by the Vietnam Ministry of Health is anticipated in December 2021.