Arcturus Therapeutics Holdings Inc. and CSL announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154, a next generation mRNA vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The companies (Arcturus and CSL Seqirus) anticipate an approval decision by the European Commission in 2024. The EMA submission is based on successful Phase 3 clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster.

In an analysis of 6-month data from the pivotal Phase 3 study, the primary efficacy endpoint was met and ARCT-154 as a primary series resulted in 56.6% efficacy for prevention of symptomatic COVID-19 overall, and 95.3% efficacy for prevention of severe COVID-19 including COVID-19 related deaths. The study was conducted when Delta variant was dominant in Vietnam. The booster data result was previously announced by CSL Seqirus' partner, Meiji Seika Pharma, indicating that the primary endpoint was achieved in a Phase 3 booster vaccine study by demonstrating non-inferiority of immune response against SARS-CoV- 2 ancestral strain compared to Comirnaty®?.

Superiority of ARCT-154 in neutralizing antibody response against SARS- CoV-2 Omicron BA.4/5 variant was a key secondary endpoint. The unique combination of commercial strength, R&D focus and operational excellence enables to identify, develop and deliver innovations so patients can live life to the fullest.