"Interim Phase 1 data expected H2 2025
(...) Arcturus Therapeutics (...) today announced the initiation of the Company’s Phase 1 study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate, also known as LUNAR-H5N1, for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
The randomized placebo-controlled Phase 1 trial (NCT06602531) is being conducted at multiple sites in the U.S. and designed to enroll approximately 200 healthy adults (120 participants 18-59 years old; 80 participants 60-80 years old). Screening of study participants began November 2024, with the first participant inoculated in December 2024. The clinical study is fully funded by Biomedical Advanced Research and Development Authority (BARDA).
“Clinically validating our low-dose STARR® mRNA technology in H5N1 flu is a crucial step towards pandemic preparedness,” said Joseph Payne, President and CEO of Arcturus Therapeutics. “Our team is working diligently with our partners, BARDA and CSL, in the United States and globally in this effort.”"