hVIVO PLC hailed as “another clear demonstration of the value of human challenge trials” the positive interim results from an ongoing phase IIa study of Cidara Therapeutics’ new flu jab.
The long-acting antiviral drug CD388 was benchmarked using hVIVO’s H3N2 influenza human challenge study model.
Early results showed the seasonal treatment demonstrated a reduction in viral replication and influenza infection in participants receiving a single dose of CD388 compared to those given a placebo.
The double-blinded, placebo-controlled trial involved 56 healthy volunteers, with 28 receiving a 150 mg dose of CD388 and the remaining 28 receiving a placebo. They were then challenged with an H3N2 influenza A agent.
The interim results showed that CD388 was well tolerated, with no drug-related adverse events observed, establishing preliminary clinical proof of concept for the ongoing development program of the antiviral.
Chief medical officer Dr Andrew Catchpole said: "hVIVO boasts a world-leading portfolio of human challenge models, and we are delighted to see the positive interim results outlining CD388's efficacy against H3N2 influenza, one of the two subtypes responsible for the annual influenza epidemics.
“The results are another clear demonstration of the value of human challenge trials in delivering quick efficacy data, de-risking entry into later stage clinical development.
“Importantly, the data underlined the potential of Cidara's Cloudbreak drug-Fc conjugates, of which CD388 is one example, to be efficacious long-acting therapeutics with universal protection of seasonal and pandemic influenza."
The contract research group has three decades of experience in safely conducting challenge studies across various respiratory viruses, played a crucial role in this trial.