Cidara Therapeutics presented clinical data on CD388, its investigational drug-Fc conjugate (DFC) for influenza prevention, at the OPTIONS XII for the Control of Influenza conference. The presentations highlighted safety and pharmacokinetic (PK) data from Phase 1 and Phase 2a studies, suggesting the potential for CD388 to provide universal, season-long protection against influenza A and B.
Safety Profile of CD388
An oral presentation by Dr. Taylor Sandison, Chief Medical Officer of Cidara Therapeutics, summarized safety data from three clinical trials involving 108 subjects followed for 5-14 months. The results indicated that CD388, administered via subcutaneous or intramuscular injection, was safe and well-tolerated. Notably, there were no dose-, route-, or repeat-dose-related treatment-emergent adverse events (TEAEs), supporting further clinical studies for single-dose prevention of seasonal influenza.
Pharmacokinetic Data in Japanese Participants
A poster presentation also by Dr. Sandison, detailed the pharmacokinetics and safety of CD388 in 27 healthy Japanese volunteers. Participants received a single subcutaneous dose of CD388 (50, 150, or 450 mg) or placebo. The PK parameters showed low-to-moderate variability across all doses, consistent with previous Phase 1 study results in Western participants. Safety observations were comparable across study arms, with no clinically significant TEAEs. These findings support further clinical development of CD388 in the Japanese population for seasonal influenza prevention.
About CD388
CD388 is a drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor conjugated to a proprietary Fc fragment of a human antibody. Unlike vaccines or monoclonal antibodies, DFCs are low molecular weight biologics designed to function as long-acting small molecule inhibitors. CD388 aims to provide universal protection against all known strains of seasonal and pandemic influenza with a single administration, regardless of the individual's immune status. The FDA granted Fast Track Designation to CD388 in June 2023, and Cidara plans to initiate a Phase 2b trial in the 2024 Northern Hemisphere influenza season.
