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Cidara to present phase IIb NAVIGATE trial data and dose optimization models for CD 388 at ICAR 2025
Cidara Therapeutics, Inc, a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies, announced two upcoming presentations at the 38th International Conference on Antiviral Researcah (ICAR). The conference takes place from March 17-21, 2025 in Las Vegas, Nevada. Cidara’s presentations will highlight the study design, demographic information, and preliminary safety data from the ongoing Phase IIb NAVIGATE trial of CD 388, as well as dose optimization models for evaluation of CD388 in a Phase 3 study.
Presentation details:
Title: NAVIGATE: A Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Study to Evaluate the Efficacy and Safety of CD 388, a Novel Long-acting Antiviral Conjugate, for Prevention of Influenza in Subjects not at Risk for Influenza Complications
Presenter: James Alexander
Abstract number: 361
Date/Time: Poster Session 1: Tuesday, March 18, 2025, 5:15-6:15pm PT; Poster Session 2: Thursday, March 20, 2025, 9-10am PT
Summary: The Phase IIb NAVIGATE trial to evaluate the safety and preventative efficacy of CD 388 in a real-world environment completed enrollment of more than 5,000 participants in the United States and the UK. Prior Phase 1 and Phase IIa clinical data have shown that CD 388, administered by subcutaneous injection, appeared to be well-tolerated and efficacious in healthy human volunteer studies. The results of the Phase IIb trial will inform dose selection and design for the planned Phase III development program.
Title: Real World Data-Based Modeling of Seasonal Influenza Variations to Support Clinical Dose Selection of CD 388, A Novel Antiviral in Development for Prevention of Seasonal and Pandemic Influenza
Presenter: Shawn Flanagan
Abstract number: 352
Date/Time: Poster Session 1: Tuesday, March 18, 2025, 6:15-7:15pm PT; Poster Session 2: Thursday, March 20, 2025, 8-9am PT
Summary: In trials involving community acquired infections, like influenza, variations in disease incidence over time may complicate interpretation of drug effect in Phase II and Phase III trials across multiple seasons, especially for long-acting drugs like CD 388. Advanced model-based analysis was conducted to improve decision power based on simulated Phase II results over different flu seasons. While a standard proportions test was shown to be sensitive to influenza seasonal variations, the model-based analysis was not and increased decision power for clinical dose selection of CD388 for Phase III.
