Arcturus' COVID-19 Vaccine Candidate Meets Primary Goal In Vietnam Study

Arcturus Therapeutics Holdings Inc ARCT shared topline data from an ongoing Phase 1/2/3 trial evaluating the ARCT-154, a self-amplifying mRNA COVID-19 vaccine candidate.
Results from the efficacy analysis have been submitted to the Vietnam Ministry of Health by Vinbiocare on April 13 and shared with Arcturus in parallel with this filing.
The Phase 3 vaccine efficacy portion of this study enrolled over 16,000 participants. The trial met its primary endpoint of prevention of virologically confirmed COVID-19 disease.
Related: Piper Comments On Increased Interest To Invest In Arcturus, 'Incrementally Positive' On Argenx.
Two 5-mcg doses of ARCT-154 demonstrated 55% vaccine efficacy for protection against COVID-19.
95.3% of vaccine efficacy was observed in severe (including fatal) COVID-19 cases.
Forty-one cases of severe COVID-19 infection occurred in the placebo group, and two in the ARCT-154 vaccinated group.
Nine COVID-19-related deaths were reported in the placebo group and 1 in the ARCT-154 older age group participant who was also at increased risk of severe COVID-19.
Arcturus has advanced ARCT-154 (5 mcg) toward a pivotal booster study, including approximately 2,400 participants.
Price Action: ARCT shares are down 7.99% at $23.24 during the market session on the last check Wednesday.