Cidara Therapeutics and hVIVO have announced encouraging topline results from a global phase 2b field study evaluating CD388, a drug-Fc conjugate developed as a non-vaccine preventative against seasonal influenza.
As part of the trial, 817 healthy participants were recruited and dosed by hVIVO at its Plumbers Row facility. Participants were given either CD388 or a placebo, then monitored over 24 weeks through regular check-ups while living outside the clinic.
hVIVO’s lab, hLAB, led all virology and immunology testing for the 61-site trial covering about 5,000 participants. Analyses included 60,000 antibody assays and 450 PCR tests, plus detailed genotypic and phenotypic reviews carried out at the company’s Canary Wharf laboratory.
The study met its primary endpoint, achieving statistically significant prevention efficacy with p <0.0001. Each of the three dose groups showed significant reductions in laboratory and clinically confirmed flu cases. Only 0.7% of participants who received a 450 mg dose experienced influenza-like illness, compared with 2.8% in the placebo group.
Secondary endpoints were also achieved, including temperature-related efficacy and maintained effect beyond the trial’s end.
Following the results, Cidara has requested an end of phase 2 meeting with the FDA to plan the upcoming phase 3 trial.
Yamin ‘Mo’ Khan, hVIVO CEO, said: “This has been our largest field study clinical conduct and hLAB laboratory support contract to date, and we are pleased to have worked with Cidara to assess the efficacy and safety of their candidate for the prevention of seasonal influenza.”
Dr Andrew Catchpole, Chief Scientific Officer, added: “These are extremely impressive results… we are delighted to now see the product demonstrate such excellent results in this phase 2b field study.”
