Cidara Therapeutics has reported encouraging top-line outcomes from the Phase IIb NAVIGATE trial of the investigational drug-Fc conjugate (DFC), CD388, for seasonal influenza prevention in healthy adult subjects aged 18 to 64, who are not vaccinated.
The double-blind, placebo-controlled, randomised trial met its primary endpoint, showing a significant prevention efficacy (PE) across three dose groups. Subjects received a single dose of CD388 at the start of the flu season and were assessed for lab and clinically confirmed influenza over 24 weeks.
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It involved over 5,000 subjects in the UK and the US and aimed to assess the pharmacokinetics, safety, and efficacy of single doses of CD388 in preventing laboratory and clinically confirmed influenza.
Secondary endpoints, including efficacy at specific temperature thresholds and PE maintenance up to 28 weeks, were also met with statistical significance.
At 450mg, the highest dose provided 76% protection against symptomatic influenza while the 300mg and 150mg doses offered 61% and 58% protection, respectively.
Cidara noted that DFCs are not vaccines or monoclonal antibodies. They are designed to work as long-acting small-molecule inhibitors, offering season-long protection with one administration.
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By GlobalDataCD388’s mechanism of action does not rely on an immune response, making it effective in individuals regardless of their immune status.
Following the submission of an end-of-Phase II meeting request, Cidara is preparing for further discussions with the FDA regarding the Phase III trial design and timing.
Additional results from the NAVIGATE trial are expected to be presented at scientific conferences in 2025.
Cidara Therapeutics CEO and president Jeffrey Stein said: “As a long-acting antiviral drug, CD388 was designed to provide once per season protection against all strains of influenza in all people, irrespective of immune status.
“These results provide us with continued conviction in the remarkable opportunity CD388 presents to deliver broad influenza protection.”
