Press release
Arcturus Announces Self-amplifying COVID-19 mRNA Vaccine Candidate ARCT-154 Meets Primary Efficacy Endpoint in Phase 3 Study
95% Efficacy overall for prevention of severe COVID-19 disease including related deaths 55% Efficacy overall for preventing symptomatic COVID-19 disease
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\n95% Efficacy overall for prevention of severe COVID-19 disease including related deaths\n\n55% Efficacy overall for preventing symptomatic COVID-19 disease\n\nStudy conducted when Delta and Omicron variants were dominant in Vietnam\n\nIncidence of unsolicited adverse events with ARCT-154 similar to placebo; No reported cases of myocarditis or pericarditis\n\nARCT-154 to advance into a pivotal booster trial in major markets\n\n SAN DIEGO--(BUSINESS WIRE)--\nArcturus 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, today shared topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, Arcturus’ self-amplifying mRNA vaccine candidate against COVID-19 disease caused by the SARS-CoV-2 virus.\n\n“We are very pleased with these results, and to see ARCT-154 providing protection against symptomatic COVID-19 and almost complete protection against severe disease in a placebo-controlled vaccine efficacy study. This represents a key milestone for the Company and provides significant clinical validation of our STARR™ platform. We believe self-amplifying mRNA combined with our LUNAR® delivery technology will create a path to better mRNA medicines,” said Joseph Payne, President and CEO of Arcturus Therapeutics. “We are grateful to our collaborator Vinbiocare and to Vietstar, a leading CRO in Vietnam, for their extraordinary effort and efficiency in the sponsorship and analysis of this trial. We are also thankful to the study participants, investigators and clinical trial sites for their invaluable contributions to the study.”\n\nThe ongoing Phase 1/2/3 registrational study, sponsored by Arcturus’ collaborator Vinbiocare Biotechnology Joint Stock Company (“Vinbiocare”), a member of Vingroup Joint Stock Company, enrolled over 19,000 adult subjects in Vietnam, including individuals at higher risk of severe complications of COVID-19 disease. Results from the efficacy analysis of the study have been submitted to the Vietnam Ministry of Health by Vinbiocare on April 13, 2022 and shared with Arcturus in parallel with this filing. This additional efficacy data complements the data package under review by the Vietnam Ministry of Health...