What is the story about?
What's Happening?
Cidara Therapeutics has been awarded up to $339 million by the Biomedical Advanced Research and Development Authority (BARDA) to support the expanded manufacturing and clinical development of CD388, a non-vaccine influenza preventative therapeutic. The agreement includes a base contract of $58 million over 24 months to facilitate the onshoring of CD388 manufacturing to the United States, enhancing the initial commercial supply chain. This funding will also support clinical trials to demonstrate the comparability of a higher-concentration formulation and different presentations of CD388, as well as further characterize its activity against pandemic influenza strains in non-clinical models. The option periods, if exercised, could provide up to $281 million for additional studies, complementing Cidara's plans for a potential Biologics License Application submission to the FDA.
Why It's Important?
The BARDA award is significant as it aims to bolster U.S. pandemic preparedness by ensuring domestic production capabilities for CD388, a long-acting universal influenza preventative. This development is crucial for millions of Americans who are immune-compromised or have comorbidities that increase the risk of severe influenza complications. The funding will enable Cidara to expand its commercial supply capacity and ensure a reliable U.S. supply of CD388 in the event of an influenza pandemic. The initiative reflects a strategic move to enhance national health security and reduce dependency on foreign manufacturing for critical medical supplies.
What's Next?
Cidara Therapeutics plans to conduct clinical trials to validate the efficacy of CD388 in various formulations and presentations. The company will also initiate the development of clinical trial protocols for expanded populations. If the option periods are exercised, further studies will be conducted to support the potential FDA submission for CD388. The partnership with BARDA is expected to accelerate the availability of CD388, providing a robust preventative measure against influenza outbreaks.
Beyond the Headlines
The collaboration between Cidara Therapeutics and BARDA highlights the growing emphasis on developing non-vaccine therapeutics that offer broad protection against infectious diseases. CD388's design as a drug-Fc conjugate represents a novel approach in antiviral therapy, potentially setting a precedent for future developments in the field. The focus on domestic manufacturing aligns with broader governmental efforts to strengthen U.S. health infrastructure and reduce vulnerabilities in the supply chain.
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