hVIVO PLC (AIM:HVO) said it had completed a key role in a large-scale clinical trial of a new flu prevention drug that showed strong results, marking another milestone for the specialist research organisation.
The London-based company, which runs clinical trials on behalf of drug developers, helped recruit participants and provided laboratory analysis for a Phase 2b field study of CD388, an injectable treatment being developed by Cidara Therapeutics as a preventative option for seasonal influenza.
The study, which involved 5,000 participants across 61 sites globally, met its main goal. A single dose of CD388 significantly reduced the rate of flu-like illness over six months.
Among those who received the highest dose, only 0.7% reported symptoms, compared with 2.8% in the placebo group.
As part of the trial, hVIVO enrolled over 800 healthy volunteers through its FluCamp recruitment arm.
"These are extremely impressive results, with influenza prevention efficacy having been demonstrated in all CD388 dose levels tested and with statistical significance achieved not only in the primary efficacy analysis but also for all the secondary efficacy endpoints," said hVIVO chief scientific officer, Dr Andrew Catchpole.
Participants were treated at the company’s East London facility before returning home, where they were monitored and tested over several months.
Its laboratory division, hLAB, was responsible for analysing around 60,000 antibody samples and hundreds of respiratory swabs to detect flu virus levels, as well as carrying out genetic and biological assessments of any virus detected.
Cidara has now requested a meeting with the US Food and Drug Administration to review the results and discuss the next phase of development.