Cidara Therapeutics, Inc. announced on September 17, 2025, two presentations at the International Society for Respiratory Viruses (ISRV) meeting in Singapore, highlighting efficacy and safety data for CD388 from the Phase 2b NAVIGATE study and preclinical data against H5N1.
The late-breaking presentation on the Phase 2b NAVIGATE study confirmed that CD388 was well-tolerated and demonstrated statistically significant, single-dose protection against influenza illness over 24 weeks in over 5,000 healthy, unvaccinated adults aged 18-64 years old.
Preclinical data presented showed that a single subcutaneous dose of CD388 at 3 mg/kg protected 75% of ferrets from death against lethal A (H5N1) infection, while a 10 mg/kg dose provided 100% survival. CD388 substantially reduced viral titers in respiratory tracts and prevented systemic spread in ferrets, suggesting prophylactic protection against highly pathogenic pandemic strains.
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