hVIVO supports breakthrough Phase 2b results for Cidara's influenza candidate
() , a contract research organisation specialising in human challenge trials, noted positive results from a Phase 2b field study by Cidara Therapeutics, for which hVIVO recruited participants and performed virology and immunology laboratory services.
The study determined the efficacy of Cidara's CD388 candidate, designed as a non-vaccine preventative of seasonal influenza. hVIVO enrolled 817 healthy participants in the double-blind study via its dedicated volunteer recruitment arm FluCamp. Additionally, hVIVO's laboratory hLAB was selected as the sole facility for the international multi-site Phase 2b field study, to conduct the virology and immunology analysis for all 61 study sites and c. 5,000 participants worldwide.
The study met its primary endpoint with a statistically significant prevention efficacy p <0.0001 for each of the 3 dose groups who received CD388 at the beginning of the flu season, and were then evaluated over 24 weeks. 0.7% of those who were given a single 450 mg dose came down with an influenza-like illness vs 2.8% of placebo subjects. The study also met all of its secondary endpoints.
Upon the successful results, 's client submitted an end of Phase 2 request to the FDA to review the Phase 2b results and further discuss Phase 3 trial design and start time.
View from Vox
hVIVO has facilitated a Phase 2b field study for its customer Cidara to evaluate the latter's influenza prevention candidate. The study yielded positive topline results, meeting its primary and all secondary endpoints, and confirming the efficacy and safety of the candidate. It was 's largest field study clinical conduct and hLAB laboratory support contract to date.
Cidara's novel non-vaccine candidate previously demonstrated influenza illness prevention efficacy in a challenge study conducted by hVIVO, and has now done so in a Phase 2b field study. A Phase 3 study is in planning stages. was selected as the sole UK site in the multicentre study, supported by its newly introduced tiered participant recruitment offering.
The study highlighted hVIVO's growing revenue diversification, leveraging its new Canary Wharf facility - the world's largest commercial human challenge trial unit - alongside its hLAB standalone lab services, expanded recruitment offering, and ability to conduct large-scale field trials, complementing operations in its London and newly acquired German facilities.
is currently managing its largest sales pipeline to date, with major projects in advanced talks - such as the world's first Phase 3 HTC trial - anticipated to finalise by late FY25, providing strong revenue visibility for FY26. In total, the £88m mktcap company has £47m of revenue contracted for FY25, with further contract wins highly likely over the course of FY25.
retains a strong cash position (most recently reported at £44.2m), and remains well-funded to execute on its growth strategy. The company entered FY25 with strong momentum after a record FY24 that saw an 11.9% YoY increase in revenues to £62.7m as EBITDA surged by 25.9% to £16.4m.
Follow News & Updates from hVIVO:
Disclaimer & Declaration of Interest
The information, investment views and recommendations in this article are provided for general information purposes only. Nothing in this article should be construed as a solicitation to buy or sell any financial product relating to any companies under discussion or to engage in or refrain from doing so or engaging in any other transaction. Any opinions or comments are made to the best of the knowledge and belief of the writer but no responsibility is accepted for actions based on such opinions or comments. Vox Markets may receive payment from companies mentioned for enhanced profiling or publication presence. The writer may or may not hold investments in the companies under discussion.