What's Happening?
Cidara Therapeutics has been awarded up to $339 million by the Biomedical Advanced Research and Development Authority (BARDA) to support the manufacturing and clinical development of CD388, a non-vaccine influenza preventative therapeutic. The funding includes a $58 million base contract over 24 months to onshore CD388 manufacturing to the United States and conduct clinical trials. CD388 is designed to provide universal protection against all known strains of seasonal and pandemic influenza. The drug is a long-acting small molecule inhibitor that does not rely on an immune response, making it potentially effective for individuals with compromised immune systems. The award aims to expand domestic supply options and ensure U.S. availability in the event of an influenza pandemic.
Why It's Important?
The BARDA award to Cidara Therapeutics is significant as it addresses the critical need for effective influenza prevention, especially for vulnerable populations such as the elderly and those with weakened immune systems. By supporting the development of CD388, the U.S. government is investing in pandemic preparedness and enhancing the country's ability to respond to influenza outbreaks. The funding will also facilitate the onshoring of drug manufacturing, which is crucial for ensuring a stable domestic supply chain. This initiative reflects a broader strategy to bolster national health security and reduce reliance on foreign manufacturing for essential medical supplies.
What's Next?
Cidara Therapeutics will proceed with the clinical trials and manufacturing setup for CD388 in the United States. The company plans to submit a Biologics License Application to the FDA, contingent on successful trial outcomes. The U.S. government may exercise additional funding options to support further studies, which could lead to expanded use of CD388 across different populations. The collaboration with BARDA underscores the importance of public-private partnerships in advancing healthcare innovations and preparing for future health emergencies.
