Cidara Therapeutics is celebrating a major injection of funding from the US government that will be used to support the development of its experimental preventive therapy for influenza.
The sizeable $339 million award from the Biomedical Advanced Research and Development Authority (BARDA) focuses on Cidara’s CD388, which hit the mark in the phase 2b NAVIGATE trial in June, showing protective efficacy against symptomatic seasonal flu compared to placebo.
The BARDA funding starts with a $58 million tranche that will be paid to the company over 24 months and will be devoted to onshoring manufacturing of CD388 to the US “as an addition to the initial commercial supply chain,” according to the San Diego biotech. That ties in with the US administration’s strenuous efforts to have medicines used in the US produced there as well.
The funding will also go towards a new clinical trial of different formulations of CD388, including a high-concentration version of the drug-Fc conjugate (DFC), which has been designed to provide universal protection against all known strains of seasonal and pandemic influenza – potentially with a single injection.
Billed as a non-vaccine approach to protection – which will sit well with the policy shift away from vaccines under President Trump and HHS Secretary Robert F Kennedy Jr – CD388 also has the potential advantage of working equally as well in immune-compromised and immune-competent individuals.
“A long-acting, universal influenza preventative that confers broad protection against all strains of influenza across all populations is critical for pandemic preparedness, especially for the millions of Americans who are immune-compromised, have comorbidities that can lead to severe complications from influenza infection, or the elderly who have diminished response to vaccines,” said Cidara chief executive Jeffrey Stein.
He added that the award will allow the company to accelerate “domestic supply options” for the drug and ensure that there will be stocks in place if there is a flu pandemic.
The NAVIGATE trial looked at three different doses of CD388 – 150 mg, 300 mg, and 450 mg – in healthy unvaccinated adults aged 18 to 64. The study met its primary endpoint, demonstrating a statistically significant prevention efficacy (PE) at 24 weeks for each of three dose groups in subjects who got a single injection at the beginning of the flu season.
The three doses had a PE of 58%, 61%, and 76%, respectively, with few side effects beyond injection site reactions, and also achieved secondary objectives such as maintaining PE out to 28 weeks.
On the strength of the data, Cidara has started a phase 3 trial (ANCHOR), expected to enrol around 6,000 people aged 65, some with no specific comorbidities and others with comorbidities and immune-compromised status. If successful, the company intends to file for approval in high-risk settings.