What's Happening?
Cidara Therapeutics has received a $339 million award from the Biomedical Advanced Research and Development Authority (BARDA) to support the manufacturing and clinical development of CD388, a non-vaccine influenza preventative therapeutic. The award includes a $58 million base period to onshore CD388 manufacturing in the U.S. and conduct a clinical comparability trial. The funding will also support further non-clinical characterization against pandemic influenza strains and protocol development for expanded populations. The option periods could provide up to $281 million for additional studies, complementing Cidara's plans for a Biologics License Application submission to the FDA.
Why It's Important?
The BARDA award to Cidara Therapeutics underscores the importance of developing effective influenza preventatives, particularly in the context of pandemic preparedness. CD388, as a long-acting, universal influenza preventative, could provide broad protection against all strains of influenza, offering a critical tool for protecting vulnerable populations. The onshoring of manufacturing to the U.S. enhances domestic supply options, ensuring readiness in the event of an influenza pandemic. This partnership with BARDA highlights the role of public-private collaborations in advancing public health initiatives and addressing unmet medical needs.
What's Next?
With the BARDA award, Cidara Therapeutics will focus on scaling up the manufacturing of CD388 and advancing its clinical development. The company will conduct a clinical comparability trial and further characterize the therapeutic's activity against pandemic influenza strains. If successful, Cidara may proceed with a Biologics License Application submission to the FDA, potentially leading to the approval and commercialization of CD388. The option periods of the award could support additional studies, expanding the therapeutic's use in specific populations and enhancing its role in pandemic preparedness.
