Cidara Therapeutics has reached its target enrolment of 6,000 patients throughout clinical sites in the UK and US in its Phase III ANCHOR trial of CD388, a non-vaccine preventative targeting seasonal influenza.
The trial will evaluate the efficacy and safety of CD388 in high-risk groups such as immune compromised patients, those with certain comorbidities, and people over 65 years old.
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ANCHOR is a placebo-controlled, randomised, multi-centre, global, double-blind Phase III study and will assess CD388 as a one-time 450mg dose administered subcutaneously in adults and adolescents.
The study includes an interim evaluation in the first quarter of 2026 for assessing the trial size and powering assumptions.
It will also determine if additional enrolment is needed for the Southern Hemisphere flu season.
Positive results from the study may support a biologics licence application (BLA) submission for high-risk groups included in the trial.
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By GlobalDataCidara president and CEO Jeffrey Stein said: “Achieving our target enrolment of 6,000 participants ahead of the peak of flu season in the Northern Hemisphere is an important step in our efforts to evaluate CD388 as a potential single-dose, non-vaccine influenza preventative for those at high risk of complications from influenza.
“We thank the ANCHOR study participants and are grateful for the continued commitment of our investigators and clinical teams as the flu season unfolds in the Northern Hemisphere.”
Cidara is developing drug-Fc conjugate (DFC) therapeutics using its Cloudbreak platform.
Its lead candidate, CD388, is a long-acting antiviral targeting universal prevention of influenza by directly inhibiting viral proliferation with one dose.
In June 2023, the therapy received fast track designation from the US Food and Drug Administration. The company commenced the current Phase III ANCHOR trial in September 2025.
In June 2025, Cidara reported encouraging top-line outcomes from the Phase IIb NAVIGATE trial of CD388 for seasonal influenza prevention in healthy adult subjects aged 18 to 64, who are not vaccinated.
