Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, 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).

The primary objective of this initial clinical trial is to evaluate safety and immune responses of three different dose levels and two different vaccination schedules of ARCT-2304 vaccine. Immune responses are measured by hemagglutination inhibition (HAI), virus microneutralization (MN) and neuraminidase enzyme-linked lectin assays (ELLA).

ARCT-2304 (LUNAR-H5N1) utilizes clinically validated LUNAR® delivery and STARR® mRNA platform technologies. STARR® mRNA has demonstrated in multiple clinical trials its ability to elicit a robust immune response at very low dose levels, with extended persistence of neutralizing antibodies compared to approved conventional mRNA vaccines. The robust safety database of the LUNAR and STARR technologies have been established through multiple COVID-19 and seasonal influenza vaccine trials, which included more than 20,000 participants and dose ranges from 1 to 20 mcg of mRNA.

“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.”

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