hVivo reports positive results from its largest lab contract to date
By Josh White
Date: Monday 30 Jun 2025
(Sharecast News) - hVivo reported positive topline results from a phase 2b field study conducted on behalf of Cidara Therapeutics on Monday, for which it provided participant recruitment, virology, and immunology laboratory services.
The AIM-traded firm said the study evaluated CD388, a drug-Fc conjugate designed as a non-vaccine preventative for seasonal influenza.
It said the randomised, double-blind, placebo-controlled study enrolled 817 participants through its FluCamp volunteer arm at its Plumbers Row site, who were dosed and then monitored in the community over several months.
In total, the trial involved around 5,000 participants globally across 61 sites, with hVivo's hLAB serving as the sole virology lab for the study.
hVivo said its responsibilities included conducting approximately 60,000 antibody assays and around 450 PCR assays, alongside detailed genotypic and phenotypic analysis of influenza samples.
The company said it was its largest field study and laboratory contract to date.
It said the trial met its primary endpoint with statistically significant prevention efficacy.
"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," said Yamin 'Mo' Khan, chief executive of hVivo.
"We were selected as the sole UK site in this multicentre study, which is a testament to the professionalism and high standards that we uphold on behalf of our clients.
"The success of this trial also illustrates hVivo's ability to run sizeable field trials in addition to those that take place in its facilities in Canary Wharf and Germany."Only 0.7% of participants given a single 450 mg dose of CD388 developed influenza-like illness (ILI) over the flu season, compared to 2.8% in the placebo group.
The study also met all secondary endpoints, including measures based on temperature thresholds and maintained efficacy for an additional month after the trial concluded.
Following the successful outcome, Cidara had submitted a request for an end-of-phase-two meeting with the US Food and Drug Administration (FDA) to discuss the phase three trial.
"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," commented Dr Andrew Catchpole, chief scientific officer at hVivo.
"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 preventative of influenza."
At 0901 BST, shares in hVivo were up 4.09% at 11.45p.
Reporting by Josh White for Sharecast.com.
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