Cidara Therapeutics Begins Phase 2b NAVIGATE Trial for CD388 to Prevent Influenza

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company leveraging its Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies, has announced the commencement of dosing for the Phase 2b NAVIGATE trial. This study aims to assess the efficacy and safety of CD388 for the pre-exposure prophylaxis of influenza during the current flu season. The trial will involve 5,000 healthy adults in the United States and the United Kingdom who are unvaccinated and not at risk for influenza complications.

The Phase 2b NAVIGATE trial is designed as a randomized, double-blind, controlled study. Participants will receive either one of three doses of CD388 or a placebo at the beginning of the influenza season. Throughout the flu season, they will be monitored to identify breakthrough influenza cases. The study will compare the rates of laboratory and clinically confirmed influenza between the different dosage groups and the placebo group.

Jeffrey Stein, Ph.D., president and CEO of Cidara Therapeutics, highlighted the need for effective alternatives to prevent influenza, especially for those who do not respond well to seasonal flu vaccines. Stein explained that CD388 is not a vaccine and therefore does not depend on an immune response, making it potentially effective regardless of the individual's immune status. He also noted that CD388 has shown promise in preventing infections from both seasonal and pandemic strains of influenza A and B.

CD388 is an investigational drug-Fc conjugate combining multiple copies of a potent small molecule neuraminidase inhibitor with a proprietary Fc fragment of a human antibody. Unlike vaccines or monoclonal antibodies, DFCs like CD388 are designed to function as long-acting small molecule inhibitors. CD388 aims to provide universal protection against all known strains of influenza, with the potential for season-long protection from a single subcutaneous or intramuscular dose. Its efficacy is not reliant on the immune system, which could make it effective in individuals with compromised immune systems as well.

Cidara Therapeutics is pioneering the development of novel drug-Fc conjugates through its proprietary Cloudbreak® platform. These DFCs consist of targeted small molecules or peptides linked to a proprietary human antibody fragment (Fc). CD388, Cidara's lead DFC candidate, is engineered as a long-acting antiviral to prevent both seasonal and pandemic influenza with a single dose by directly inhibiting viral replication. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to CD388 in June 2023, and the company plans to proceed with the Phase 2b trial during the 2024 Northern Hemisphere flu season. Additionally, Cidara has developed other DFCs for oncology applications, including CBO421, which received IND clearance in July 2024 to target CD73 in solid tumors.

Cidara Therapeutics is headquartered in San Diego, California. The company continues to advance its pipeline of novel immunotherapies to address unmet medical needs across various serious diseases.