Cidara Therapeutics has achieved full planned subject enrolment for the randomised Phase IIb NAVIGATE trial designed to assess the safety and efficacy of its drug-Fc conjugate (DFC), CD388, for the pre-exposure prophylaxis of seasonal influenza.
The double-blind, controlled trial spans clinical sites in the US and UK and enrolled a total of 5,000 participants.
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It involves healthy, unvaccinated adults having no risk of complications from influenza.
The trial’s objective is to assess the pharmacokinetics, safety and the rates of laboratory as well as clinically confirmed influenza in participants administered with single doses of the therapy or a placebo at the onset of the flu season.
Participants in the trial will receive one of three different doses of CD388 (150mg, 300mg, 450mg) or a placebo. They will then be monitored throughout the influenza season to track any breakthrough cases of the virus.
Cidara Therapeutics CEO and president Jeffrey Stein said: “Completing the NAVIGATE study at the beginning of the northern hemisphere flu season was a critical milestone to evaluate the efficacy and safety of CD388 as a potential long-acting, universal influenza preventative.
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By GlobalData“Thanks to the efforts of our investigators and clinical teams, we are now well-positioned to advance the study as this year’s flu season unfolds.”
The ‘Cloudbreak’ platform is instrumental in developing Cidara’s drug-Fc conjugates, which combine targeted small molecules or peptides with a human antibody fragment.
In June last year, the therapy gained fast-track status from the US Food and Drug Administration (FDA), and the Phase IIb trial was initiated in September this year.
Additionally, the company has developed other DFCs for oncology, with investigational new drug (IND) clearance received in July for CBO421, targeting cluster of differentiation 73 (CD73) in solid tumours.
