ARCT - Arcturus Therapeutics on go with mid-stage U.S. study of COVID-19 vaccine ARCT-021

The FDA has allowed Arcturus Therapeutics' (ARCT) Investigational New Drug ((IND)) application for the Phase 2 clinical study of its vaccine candidate ARCT-021 following review of data from the Phase 1/2 study. The Phase 2 study will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo.Early interim analyses of safety and immunogenicity will be performed to inform dose selection for a Phase 3 study, which is targeted to start in Q2 2021, if the Phase 2 study is successful."Our prior clinical results show that ARCT-021 administration results in humoral and cellular immunogenicity, and we are encouraged by an increasing body of evidence highlighting the potential importance of T cells in providing protection against SARS-CoV-2 infection and COVID-19," said Steve Hughes, M.D., Chief Medical Officer.Recently, ARCT provided update on clinical and preclinical data for ARCT-021.Shares up 3% premarket.

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Arcturus Therapeutics on go with mid-stage U.S. study of COVID-19 vaccine, ARCT-021