Press release
Arcturus Therapeutics Announces Positive Interim ARCT-021 (LUNAR-COV19) Phase 1/2 Study Results for Both Single Shot and Prime-boost Regimens, and Up to $220 Million in Additional Financial Commitments from Singapore
Based on interim Phase 1/2 results, a single 7.5 µg dose of ARCT-021, along with prime-boost regimens are selected to advance into later stage global
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nBased on interim Phase 1/2 results, a single 7.5 µg dose of ARCT-021, along with prime-boost regimens are selected to advance into later stage global clinical trials\n\nSeroconversion in majority of participants receiving doses in the range of 5 µg to 7.5 µg; Geometric Mean Titer (GMT) levels for neutralizing antibodies in the range of convalescent plasma\n\nDose-dependent anti-spike IgG titers increased over time through approximately day 43; T cell reactivity to spike protein peptides, including receptor binding domain (RBD) observed\n\nFavorable safety and tolerability profile in both younger (ages 21-55) and older (ages 56-80) subjects; no moderate or severe fevers\n\nSingapore Economic Development Board (EDB) financial commitment includes $45 million up front to fund manufacture of ARCT-021 and up to an additional $175 million in vaccine purchases\n\nLyophilized drug product on track for Phase 3 implementation\n\n SAN DIEGO--(BUSINESS WIRE)--\nArcturus 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 positive interim clinical study results from its ongoing Phase 1/2 study of ARCT-021, its vaccine candidate for COVID-19. The Company also announced new manufacturing financial support and potential vaccine purchases up to $220 million from Singapore’s Economic Development Board (EDB).\n\nARCT-021 Phase 1/2 study overview and results\n\nARCT-021 is being developed in collaboration with Duke-NUS Medical School and ongoing Phase 1/2 development is being conducted in Singapore. ARCT-021 combines self-transcribing and replicating mRNA (STARR™) with LUNAR® lipid-mediated delivery technology, which is designed to enhance and extend antigen expression, enabling vaccination at lower doses. The ongoing Phase 1/2 randomized, double-blinded, placebo-controlled study is evaluating the safety, tolerability and immunogenicity of multiple dose levels of ARCT-021. Study subjects receive either placebo, or ARCT-021 at doses in the range of 1 µg to 10 µg per injection in either a single dose or prime-boost regimen.\n\nThe study is fully enrolled with 106 subjects, including older adult subjects. To date, 78 subjects have ...