Cidara Therapeutics is focusing on the clinical advancement of CD388, a drug-Fc conjugate (DFC) immunotherapy designed for universal prevention of seasonal and pandemic influenza. The company recently initiated the Phase 2b NAVIGATE trial and reported its third-quarter 2024 financial results.
Phase 2b NAVIGATE Trial Commences
The Phase 2b NAVIGATE trial, a randomized, double-blind, controlled study, began in September 2024. It aims to evaluate the efficacy and safety of CD388 for pre-exposure prophylaxis of seasonal influenza. The trial targets enrollment of 5,000 healthy, unvaccinated adult subjects across sites in the U.S. and UK. Participants are randomized into three CD388 dose groups and one placebo group in a 1:1:1:1 ratio. Subjects will be monitored throughout the influenza season to assess breakthrough cases, comparing rates of laboratory and clinically confirmed influenza between the CD388 and placebo groups.
CD388 Shows Promise in Earlier Trials
Data from a Phase 2a human challenge study, presented at the 2024 IDWeek Conference, demonstrated that a single subcutaneous dose of CD388, administered five days before influenza challenge, effectively prevented symptomatic disease. Additional data from a Phase 1 trial indicated that CD388 was rapidly absorbed, achieving target exposure levels regardless of intramuscular or subcutaneous injection route, with no significant safety concerns. These findings support the potential for a single dose of CD388 to provide protection throughout the influenza season.
Corporate Restructuring and Financial Update
In September 2024, Cidara announced a restructuring involving a 30% workforce reduction to concentrate on CD388's clinical development. This move is expected to reduce capital needs related to recurring personnel costs. For the third quarter of 2024, Cidara reported cash and cash equivalents totaling $127.4 million as of September 30, 2024, compared to $35.8 million as of December 31, 2023. The net loss for the quarter was $16.0 million.
Scientific Advisory Board Expansion
Cidara strengthened its Scientific Advisory Board (SAB) in September 2024 with the appointment of four infectious disease experts: Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick Hayden, M.D., FACP. Their expertise in influenza, pandemic preparedness, and clinical and regulatory processes is expected to be invaluable as the Phase 2b NAVIGATE trial progresses.
Leadership Changes
In August 2024, Jim Beitel was appointed as Chief Business Officer, bringing over 20 years of experience in life science corporate development to Cidara.
Rezafungin Asset Sale
On April 24, 2024, Cidara completed the sale of its rezafungin assets to Napp Pharmaceutical Group Limited, an affiliate of Mundipharma Medical Company. The financial results of rezafungin have been reported as discontinued operations in Cidara's condensed consolidated statements of operations.
