Positive results from hVIVO study of Cidara flu candidate

Study demonstrated a reduction in viral replication in the upper respiratory tract as well as influenza infection

hVIVO – a company focused on testing global infectious and respiratory disease products through clinical trials – has recorded positive interim results from its study involving Cidara Therapeutics’ CD388 influenza therapy.

hVIVO is currently conducting the wider phase 2a single-location, randomised, placebo-controlled trial using its established ‘H3N2 Influenza Human Challenge Study Model’.

Candidate CD388 is a long-acting conjugate antiviral for treating seasonal influenza. The mid-term analysis comes from research on 56 healthy volunteers, with 28 receiving a single dose of CD388 –150mg – and the remaining members of the group receiving a placebo. The entire cohort also received H3N2 influenza – a notable challenge agent.

The study demonstrated a reduction in viral replication in the upper respiratory tract as well as influenza infection in participants receiving a single dose of the treatment when compared to the placebo.

Furthermore, CD388 was well-tolerated with no adverse events witnessed. The data has also underlined preliminary clinical proof of concept for the drug’s continuing development programme.

Dr Andrew Catchpole, chief scientific officer at hVIVO, was impressed by the results: “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.”

He added: “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.”