- 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.
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