- Arcturus Therapeutics (ARCT, Financial) receives FDA Fast Track Designation for its ARCT-2304 mRNA vaccine candidate against pandemic influenza A H5N1.
- Phase 1 clinical trials for this innovative vaccine commenced in November 2024.
- The project is fully funded by federal support through BARDA contract 75A50122C0007.
Arcturus Therapeutics Holdings Inc. (ARCT), a leader in mRNA medicine, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for its self-amplifying mRNA vaccine candidate, ARCT-2304. This designation targets pandemic influenza A virus H5N1, a serious global health threat. Fast Track Designation is intended to expedite the development and review of drugs and vaccines that address serious conditions and fulfill unmet medical needs. It provides ARCT-2304 with benefits such as enhanced communication with the FDA, eligibility for priority review, and the possibility of a rolling review.
The Phase 1 clinical study of ARCT-2304 began in November 2024. The vaccine leverages Arcturus' proprietary STARR® technology platform, which is designed to enhance the immune response while potentially requiring lower doses than conventional mRNA vaccines. This innovative sa-mRNA platform could play a crucial role in pandemic preparedness by allowing rapid vaccine production and distribution.
The development of ARCT-2304 is backed by federal funding through a contract with the Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C0007. This support underscores the potential impact and importance of ARCT-2304 in addressing pandemic threats, while also providing financial security and validating Arcturus' approach in the infectious disease vaccine domain.
