Cidara Completes Phase 2b Trial Enrollment for CD388 in Seasonal Flu Prevention

On Dec. 4, 2024, Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced the completion of the planned enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial. This biotechnology company, known for its Cloudbreak® platform, focuses on developing drug-Fc conjugate (DFC) immunotherapies to enhance patient care for serious diseases. The NAVIGATE trial aims to assess the efficacy and safety of CD388, a DFC for the pre-exposure prophylaxis of seasonal influenza, across clinical sites in the US and UK.

Jeffrey Stein, Ph.D., president and CEO of Cidara, emphasized the significance of completing the NAVIGATE study at the start of the northern hemisphere's flu season. This milestone is pivotal for evaluating CD388 as a potential universal influenza preventative with long-lasting effects. Stein credited the investigators and clinical teams for their efforts in positioning the study well for the unfolding flu season.

The NAVIGATE trial is a randomized, double-blind, controlled study involving healthy, unvaccinated adult participants who are not at risk for influenza complications. The primary goal is to assess the safety, pharmacokinetics, and incidence of laboratory and clinically confirmed influenza in subjects receiving single doses of CD388 (150mg, 300mg, 450mg) or a placebo at the beginning of the flu season. Participants will be monitored for the entire influenza season to detect breakthrough cases.

CD388 is an investigational drug-Fc conjugate that includes 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 act as long-acting small molecule inhibitors. CD388 is intended to offer universal protection against all known seasonal and pandemic influenza strains with a single subcutaneous or intramuscular administration. Since CD388 is not a vaccine, its effectiveness does not depend on an immune response, making it potentially efficacious for individuals regardless of their immune status.

Cidara Therapeutics leverages its Cloudbreak® platform to create novel drug-Fc conjugates (DFCs) composed of targeted small molecules or peptides linked to a proprietary human antibody fragment (Fc). CD388, Cidara’s lead DFC candidate, is a long-acting antiviral aimed at achieving universal prevention of seasonal and pandemic influenza through direct inhibition of viral replication. In June 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to CD388, and Cidara initiated the Phase 2b trial in September 2024.

Additionally, Cidara has developed other DFCs for oncology. In July 2024, the company received IND clearance for CBO421, a DFC targeting CD73 in solid tumors. Cidara Therapeutics is based in San Diego, California.