Arcturus Therapeutics, a company specializing in mRNA-based pharmaceuticals, quietly announced Monday that the U.S. Food and Drug Administration (FDA) has granted approval for its Investigational New Drug (IND) application for ARCT-2304, a self-amplifying mRNA (sa-mRNA) injection targeting the H5N1 avian influenza “bird flu” virus.
The FDA has recently come under fire for “failing to meet safety requirements” and “failing to prioritize scientific data quality delivered from FDA laboratories,” according to the U.S. House of Representatives Committee on Energy and Commerce.
The new Arcturus trial, funded by the Biomedical Advanced Research and Development Authority (BARDA), aims to assess ARCT-2304’s efficacy in preventing pandemic influenza and plans to enroll around 200 healthy adults across the United States.
“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process,” said Joseph Payne, President & CEO of Arcturus Therapeutics in a press release.
“The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.”
Hellbound and Down 