For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250630:nRSd8283Oa&default-theme=true
RNS Number : 8283O hVIVO PLC 30 June 2025
hVIVO plc
("hVIVO" or the "Company")
Positive topline results from client Phase 2b field study
hVIVO recruited participants and performed the virology and immunology
laboratory services for the study
hVIVO plc (AIM: HVO), a full-service Contract Research Organisation (CRO)
and the world leader in human challenge clinical trials, congratulates Cidara
Therapeutics (Cidara: Nasdaq CDTX) on the positive topline results from their
Phase 2b 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, multicenter dose
selection study hVIVO enrolled 817 healthy participants via the Company's
dedicated volunteer recruitment arm, FluCamp
(https://protect.checkpoint.com/v2/___https:/flucamp.com/___.YzJ1OmNpZGFyYXRoZXJhcGV1dGljczpjOm86NGI1ZTVkN2YwOWEyMzA2MjNkMTUzZDc0ZGY1MmIyODk6NjplMjk5OjY1ODkxMWUxZGNkOWY1ZjQxOTc1NDM0NDUxNGFmMGI5MWQyZTc4ZmQ1MWVlZWU5ZjdkZTlhOGY0NWQ2ZDJiNGY6cDpUOk4)
. 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, where they
were monitored over 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, multi-site Phase 2b 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 participant's samples. In addition, the contract
includes more extensive analysis on the virus detected in participant samples
via genotypic and phenotypic analyses -all carried out 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
over 24 weeks. 0.7% of the subjects who were given a single 450 mg dose came
down with an influenza-like illness (ILI) over 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 2
meeting request to the FDA to review the Phase 2b results and further discuss
the Phase 3 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. 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.
"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
preventative of influenza".
For further information please contact:
hVIVO plc +44 (0)20 7756 1300
Yamin 'Mo' Khan, Chief Executive Officer
Stephen Pinkerton, Chief Financial Officer
Cavendish Capital Markets Limited (Nominated Adviser and Joint Broker) +44 (0)20 7220 0500
Geoff Nash, Callum Davidson,
Trisyia Jamaludin, Harriet Ward
Nigel Birks - Life Science Specialist Sales
Louise Talbot - Sales
Peel Hunt LLP (Joint Broker) +44 (0)20 7418 8900
James Steel, Dr Christopher Golden
Davy (Joint Broker) +353 (0) 1 679 6363
Anthony Farrell, Niall Gilchrist
Walbrook PR (Financial PR & IR) +44 (0) 20 7933 8780 or hvivo@walbrookpr.com
Paul McManus / Alice Woodings / +44 (0)7980 541 893 / +44 (0)7407 804 654/
Lianne Applegarth +44 (0)7584 391 303
Notes to Editors
hVIVO plc
(https://protect.checkpoint.com/v2/___https:/hvivo.com/___.YzJ1OmNpZGFyYXRoZXJhcGV1dGljczpjOm86NGI1ZTVkN2YwOWEyMzA2MjNkMTUzZDc0ZGY1MmIyODk6NjpjNDgxOmZkYjBmOGQ2NmIyOTcwNDJmNGJkZjFkOWVmYzI1MmE2OGEwMTdmMjMzNTQ4YWVlYTg1YjgzZjAwZmJkMzc0NGE6cDpUOk4)
(Ticker: HVO) is full-service early-phase Contract Research Organisation (CRO)
and the global leader in human challenge trials. The company delivers
end-to-end clinical development services to a diverse and expanding client
base, including seven of the world's ten largest biopharma companies.
hVIVO specialises in conducting human challenge trials across multiple
infectious and respiratory indications, leveraging its state-of-the-art
quarantine facility in London-the largest of its kind worldwide. The company
also offers comprehensive virology and immunology laboratory services under
the hLAB
(https://protect.checkpoint.com/v2/___https:/hlabservices.com/___.YzJ1OmNpZGFyYXRoZXJhcGV1dGljczpjOm86NGI1ZTVkN2YwOWEyMzA2MjNkMTUzZDc0ZGY1MmIyODk6Njo4NDI3OjM4YzRiNDBkMjg4Mzk2M2IzMjNlYzgyYzY5OGY4NzE1ODU1NTc3MjVlODdmNzcxMjQwNDNmOWE1MzI4ZDhkYmM6cDpUOk4)
brand.
Through its German subsidiary, CRS
(https://protect.checkpoint.com/v2/___https:/crs-earlyphase.com/___.YzJ1OmNpZGFyYXRoZXJhcGV1dGljczpjOm86NGI1ZTVkN2YwOWEyMzA2MjNkMTUzZDc0ZGY1MmIyODk6NjoyNmIxOmYzN2ZiOTAzYjYzMWFmMmVjNDA2OTY3NzVmODg5NmQ2NTlmZmNkMzgxMTcxNDNmYzBlMGYxMDE2NGMyNjE5NDA6cDpUOk4)
, hVIVO operates a 120-bed capacity across Mannheim and Kiel, providing
early-phase clinical trial services, including first-in-human and
proof-of-concept studies. Its second subsidiary, Venn Life Sciences
(https://protect.checkpoint.com/v2/___https:/www.vennlifesciences.com/___.YzJ1OmNpZGFyYXRoZXJhcGV1dGljczpjOm86NGI1ZTVkN2YwOWEyMzA2MjNkMTUzZDc0ZGY1MmIyODk6NjplYTdmOjgzYmE4NThiMzYyYmNiNzg5ZmU0ZDcwZWMzZmE1YTZmZDMxODRkY2NiZWZjOWNmNjM3ODhmYTUzNmQxNjI3Mzk6cDpUOk4)
, offers Early Drug Development Consulting and Biometry services to the
biopharma sector.
The Group provides fully integrated drug development solutions from
preclinical stages through Phase II trials, alongside patient recruitment via
FluCamp
(https://protect.checkpoint.com/v2/___https:/flucamp.com/___.YzJ1OmNpZGFyYXRoZXJhcGV1dGljczpjOm86NGI1ZTVkN2YwOWEyMzA2MjNkMTUzZDc0ZGY1MmIyODk6NjplMjk5OjY1ODkxMWUxZGNkOWY1ZjQxOTc1NDM0NDUxNGFmMGI5MWQyZTc4ZmQ1MWVlZWU5ZjdkZTlhOGY0NWQ2ZDJiNGY6cDpUOk4)
. Additionally, its five clinical sites support outpatient Phase II and III
trials, ensuring a seamless and efficient pathway from discovery to late-stage
development.
This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END NRAPPUUWQUPAGAM