Vietnam's Health Ministry Approves Phase 2, Phase 3 Cohorts Of Arcturus' COVID-19 Vaccine Trial

  • Arcturus Therapeutics Holdings Inc ARCT has completed dosing of 100 subjects for the Phase 1 portion of the ARCT-154 Phase 1/2/3 trial, which consisted of a two-dose regimen with injections 28 days apart. 
  • The Vietnam Ministry of Health has reviewed the safety data in the Phase 1 part of the study and has permitted Phase 2 and Phase 3a cohorts. 
  • The Phase 2 and Phase 3a studies will evaluate safety and immunogenicity in an additional 900 subjects. Recruitment of these cohorts is now progressing. 
  • The subsequent Phase 3b will assess safety and efficacy in approximately 20,000 subjects. Dosing is planned for the first week of October.
  • Emergency Use Authorization filing in Vietnam could be as soon as December 2021.
  • The tolerability profile of ARCT-154 in the Phase 1 study was favorable. 
  • Related: Arcturus Therapeutics Stock Jumps On mRNA COVID-19 Vaccine Update.
  • Price Action: ARCT stock is up 3.81% at $53.79 during the market session on the last check Wednesday.
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Posted In: BiotechNewsHealth CareSmall CapMoversTrading IdeasGeneralBriefsCOVID-19 CoronavirusCOVID-19 VaccinePhase 2 TrialPhase 3 Trial
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