Benzinga | Jan 4, 2021 07:07AM EST

Arcturus Therapeutics Receives FDA Allowance To Proceed With Phase 2 Study Of ARCT-021 (LUNAR-COV19) Vaccine Candidate In United States

Phase 2 study to be conducted in the U.S. and Singapore, and will evaluate both single dose and two dose priming regimens of ARCT-021 in up to 600 participants

Anticipate interim Phase 2 data in early 2021; targeting global Phase 3 study start in Q2 2021 which could allow application for emergency use authorization/conditional approval in H2 2021

Arcturus 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 announced that the Company has received allowance of the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical study of its vaccine candidate ARCT-021 following review of data from the Phase 1/2 study.

Arcturus previously announced that the ARCT-021 Phase 2 study had been approved to proceed by the Singapore Health Sciences Authority (HSA), who reviewed the same data as reviewed by the FDA. These Phase 1/2 study results demonstrated favorable tolerability and both humoral and cellular immunogenicity following administration of ARCT-021.

The Phase 2 study will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Both older and younger adult participants will be included. 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.

"Allowance of the IND for our ARCT-021 Phase 2 clinical study represents an important milestone for the program and we look forward to starting to screen study participants at U.S. and Singapore clinical sites very soon," said Steve Hughes, M.D., Chief Medical Officer of Arcturus. "We have advanced ARCT-021 to Phase 2 based on promising interim results from our Phase 1/2 study and extensive preclinical data. 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. We believe that ARCT-021 holds promise to be a highly effective vaccine with a differentiated clinical profile, including the potential to only require a single dose for protection."