Cidara Therapeutics has announced the completion of enrollment in its Phase IIb NAVIGATE trial, designed to evaluate the safety and efficacy of CD388 for the pre-exposure prophylaxis of seasonal influenza. The double-blind, controlled trial, conducted across clinical sites in the US and UK, reached its target enrollment of 5,000 participants.
NAVIGATE Trial Details
The NAVIGATE trial focuses on healthy, unvaccinated adults who are not at high risk of influenza-related complications. Participants receive a single dose of CD388 at one of three different dose levels (150mg, 300mg, or 450mg) or a placebo at the beginning of the influenza season. Following administration, subjects are monitored throughout the flu season to detect any breakthrough cases of the virus.
The primary objective of the trial is to assess the pharmacokinetics, safety, and rates of laboratory-confirmed and clinically confirmed influenza in participants treated with CD388 compared to placebo.
CD388: A Novel Approach to Influenza Prevention
CD388 is a drug-Fc conjugate (DFC) developed using Cidara's Cloudbreak platform. This platform combines targeted small molecules or peptides with a human antibody fragment. The drug is intended to provide pre-exposure prophylaxis against seasonal influenza. In June of last year, CD388 was granted fast-track designation by the US Food and Drug Administration (FDA), and the Phase IIb trial was initiated in September.
Management Commentary
Jeffrey Stein, CEO and president of Cidara Therapeutics, stated that completing the NAVIGATE study at the beginning of the northern hemisphere flu season was a critical milestone. The trial will evaluate the efficacy and safety of CD388 as a potential long-acting, universal influenza preventative. He also acknowledged the efforts of the investigators and clinical teams in advancing the study as the flu season unfolds.
Current Treatment Landscape
Seasonal influenza remains a significant public health concern, with substantial morbidity and mortality, particularly among vulnerable populations. Current prevention strategies primarily rely on annual vaccination, which can be limited by strain variability and vaccine effectiveness. The development of novel prophylactic agents like CD388 could address unmet needs in influenza prevention by providing broader and more durable protection.
