Cidara Secures $339M BARDA Deal for Non-Vaccine Flu Preventative, Marking Shift in U.S. Pandemic Preparedness Strategy

Cidara Therapeutics has landed a significant federal contract worth up to $339 million from the Biomedical Advanced Research and Development Authority (BARDA) to advance the development and domestic manufacturing of its novel non-vaccine flu preventative, CD388. This deal comes as part of a broader shift in U.S. pandemic preparedness strategy, moving away from mRNA vaccine investments towards alternative preventative measures.

BARDA Funding Boosts Cidara's CD388 Development

The agreement includes an initial $58 million in funding over two years, primarily aimed at establishing U.S.-based manufacturing capabilities for CD388 and developing Cidara's initial commercial supply chain. This funding will also support a clinical trial exploring higher-concentration formulations and different presentations of CD388, as well as further characterization of the asset's effectiveness against pandemic flu strains in non-clinical models.

Additional options worth $281 million could fund studies of CD388 in specific populations, complementing Cidara's plans for an FDA approval application. Jeffrey Stein, Ph.D., Cidara's CEO, expressed optimism about the deal, stating, "Clinical and non-clinical data generated to date suggest that CD388 has the potential to be an effective non-vaccine preventative for both pandemic and seasonal influenza."

CD388: A Novel Approach to Flu Prevention

CD388 represents a departure from traditional vaccine approaches to flu prevention. As a drug-Fc conjugate, it combines multiple copies of a potent small molecule neuraminidase inhibitor with a custom Fc fragment of a human antibody. This design allows CD388 to function as a long-acting small molecule inhibitor, potentially offering protection against all known strains of seasonal and pandemic influenza, regardless of a patient's immune status.

Cidara's recent phase 2b study, Navigate, demonstrated promising results for CD388. The highest 450 mg dose conferred 76% protection against seasonal influenza in unvaccinated adults compared to placebo, with lower doses also showing significant protective effects.

Building on these results, Cidara has initiated an accelerated development plan, including a single phase 3 study aiming to enroll 6,000 subjects. The company has already dosed the first participants in this program, marking a rapid progression in CD388's clinical development.

Shifting Landscape of U.S. Pandemic Preparedness

The substantial BARDA investment in Cidara's non-vaccine approach comes amid a significant policy shift in U.S. pandemic preparedness strategy. Earlier this year, the Department of Health and Human Services, under the leadership of Robert F. Kennedy Jr., announced the termination of 22 mRNA vaccine development investments previously funded by BARDA.

Kennedy justified this decision, stating, "BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We're shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate."

This pivot in strategy underscores a growing interest in alternative approaches to pandemic prevention and highlights the potential significance of Cidara's CD388 in future public health responses to influenza outbreaks.