What is the story about?
What's Happening?
Cidara Therapeutics has received a substantial $339 million award from the Biomedical Advanced Research and Development Authority (BARDA) to advance its experimental influenza prophylactic, CD388. This funding will support the onshoring of CD388 manufacturing to the United States and the initiation of a new clinical trial exploring various formulations of the drug. CD388, which demonstrated protective efficacy in the phase 2b NAVIGATE trial, is designed to offer universal protection against all known strains of seasonal and pandemic influenza with potentially a single injection. The funding aligns with the U.S. administration's policy to produce medicines domestically and shift away from traditional vaccines. CD388 is particularly promising for immune-compromised individuals and those with comorbidities, offering a non-vaccine approach to flu prevention.
Why It's Important?
The BARDA award is significant as it underscores the U.S. government's commitment to enhancing pandemic preparedness through innovative medical solutions. By supporting the development of CD388, the funding aims to provide a long-acting, universal influenza preventative that could benefit millions of Americans, especially those at higher risk of severe flu complications. This initiative also reflects a strategic move to bolster domestic pharmaceutical manufacturing capabilities, reducing reliance on foreign production. The success of CD388 could lead to a paradigm shift in how influenza is managed, potentially reducing the burden on healthcare systems and improving public health outcomes.
What's Next?
Cidara Therapeutics plans to commence a phase 3 trial, ANCHOR, which will enroll approximately 6,000 participants, including those aged 65 and older with various health conditions. The trial's success could pave the way for regulatory approval in high-risk settings. Additionally, the company aims to establish a robust domestic supply chain for CD388, ensuring readiness for potential flu pandemics. The outcome of these efforts will be closely monitored by healthcare stakeholders and could influence future public health policies regarding influenza prevention.
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