hVIVO, a full-service contract research organisation (CRO) and the world leader in human challenge clinical trials, congratulates Cidara Therapeutics on the positive topline results from their Phase 2II field study, for which hVIVO recruited participants and performed the virology and immunology laboratory services.
The study was to determine the efficacy of Cidara’s drug-Fc conjugate, CD388, which is designed as a non-vaccine preventative of seasonal influenza.
As part of the randomised, double-blind, placebo-controlled, multicentre dose selection study, hVIVO enrolled 817 healthy participants via the Company’s dedicated volunteer recruitment arm, FluCamp.
Participants were administered with either a dose of CD388 or a placebo at hVIVO’s Plumbers Row site and then free to leave the facilities; they were monitored during the following months, with regular clinical check-ups, to collect samples and data used to assess the efficacy and safety of the candidate.
hVIVO’s laboratory, hLAB, was selected as the sole virology laboratory for this international, multisite Phase 2 field study to conduct the comprehensive virology and immunology analysis for the 61 study sites and approximately 5,000 participants worldwide.
hLABs’ responsibilities on the study include the conduct of ~60,000 antibody assays on serum samples and approximately 450 PCR assays on respiratory swabs to detect and quantify influenza virus levels in the participants’ samples.
In addition, the contract includes more extensive analysis on the virus detected in participant samples via genotypic and phenotypic analyses —all done at hVIVO’s state-of-the-art laboratory facility in Canary Wharf.
The study met its primary endpoint with a statistically significant prevention efficacy (PE), p <0.0001.
Furthermore, the primary efficacy analysis showed a statistically significant PE for each of three dose groups in individuals who received a single dose of CD388 at the beginning of the flu season and were evaluated for laboratory and clinically confirmed influenza for 24 weeks.
Only 0.7% of the subjects who were given a single 450 mg dose came down with an influenza-like illness (ILI) during the course of the flu season.
This was statistically significant versus the 2.8% of placebo subjects who experienced ILI. The study also met all its secondary endpoints, including efficacy in participants with temperatures of 37.8 and 37.2 degrees Celsius, as well as maintenance of efficacy for another month after the end of the trial.
Upon the success of these results, the client has submitted an end of Phase II meeting request to the FDA to review the Phase IIb results and further discuss the Phase III trial design and start time.
Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, 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."
“It is very pleasing to see positive results from this study, which was supported by our newly introduced tiered participant recruitment offering, and this is a good example of the successful delivery of our diversified hVIVO revenue streams.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “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."
"This product previously demonstrated influenza illness prevention efficacy in a challenge study conducted by hVIVO, so we are delighted to now see the product demonstrate such excellent results in this phase 2b field study."
"At hVIVO, we are pleased to have been able to continue to help in the clinical development of this important and novel non-vaccine preventive of influenza.”
