Cidara Therapeutics Announces Publication of CD388 Preclinical Data in Nature Microbiology
SAN DIEGO -- Cidara Therapeutics, Inc., a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies, today announced the publication of preclinical data assessing CD388, the company’s influenza DFC, in the peer-reviewed scientific journal Nature Microbiology. The article, entitled “Drug-Fc Conjugate CD388 targets influenza virus neuraminidase and is broadly protective in mice,” highlights the potential of CD388 as a potent, universal preventative for influenza A and B in healthy and high-risk populations.
“This publication, combined with the promising clinical data we’ve generated to date, further validates our Cloudbreak DFC platform and the potential of CD388 to offer universal protection against both seasonal and pandemic influenza strains,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “While vaccines play a vital role in flu prevention, they do not offer sufficient protection, particularly for immune-compromised individuals, underscoring the critical need for a durable, broadly acting antiviral like CD388. We look forward to the results of our ~5,000 subject Phase 2b NAVIGATE study that is evaluating CD388 during the particularly severe 2024-2025 flu season.”
Key Findings
The publication describes CD388 and its potential for universal activity across influenza A and B viruses in cellular and animal models.
Administration of CD388 resulted in the following:
Ø Potent, universal activity against all influenza A and B virus strains, including high pathogenicity strains like H5N1, also known as avian influenza or bird flu, and strains that are resistant to approved neuraminidase inhibitors
Ø Low potential for resistance development
Ø Efficacy at similar exposures in immune-competent and immune-compromised lethal challenge models in mice demonstrating that efficacy is driven predominantly by the intrinsic antiviral activity of CD388
CD388 is currently under clinical evaluation in the ~5000 patient Phase 2b NAVIGATE trial, evaluating CD388 for the single-dose prevention of seasonal influenza in healthy unvaccinated adult subjects.
