REG - hVIVO PLC - £2m hMPV characterisation study contract

hVIVOAnnouncement

17/02/2025 07:00

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RNS Number : 2613X  hVIVO PLC  17 February 2025

hVIVO plc

("hVIVO", the "Company" or the "Group")

 

£2m hMPV characterisation study contract

 

hVIVO plc (AIM: HVO), a fast-growing early-stage Contract Research
Organisation (CRO) and the world leader in human challenge clinical trials,
announces that, following the success of its pilot human metapneumovirus
("hMPV") characterisation trial announced in January 2025
(https://polaris.brighterir.com/public/hvivo/news/rns/story/w0okn8w) , it has
signed a £2 million contract with a new biopharmaceutical client to complete
the final stage of the characterisation study ahead of future hMPV human
challenge trials ("HCTs").

 

The pilot characterisation trial produced a safe, measurable and reproducible
disease in healthy volunteers, demonstrating strong infection and symptomatic
response rates. It also confirmed the optimal dose of the challenge agent,
validating the viability of hVIVO's hMPV human challenge model. This next
phase aims to expand the dataset by enrolling additional healthy volunteers,
further strengthening the model and ensuring robust powering for future hMPV
HCTs. The final phase of the study is expected to commence in H125, with the
revenue being recognised in 2025.

 

The Company has active interest in this challenge model from prospective
clients and should be in a position to commence hMPV HCTs from H225, subject
to the successful completion of this study and receipt of the necessary
regulatory approvals. With over three decades of expertise in challenge agent
manufacturing and human challenge model development and world leading
facilities, the Company continues to lead in safely conducting HCTs for a
broad range of infectious and respiratory diseases.

 

Given the rising global focus on hMPV due to recent outbreaks and increasing
case numbers, the Company anticipates growing demand for hMPV drug development
services. hVIVO is proud to support global biopharmaceutical companies by
generating fast, cost-effective efficacy data to accelerate the development of
critical vaccines and antivirals. These efforts can facilitate regulatory
designations, drive product acquisitions, expedite market approval and
ultimately address critical unmet medical need.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We are pleased to
have secured this £2 million contract with a new biopharmaceutical client so
soon after the successful pilot hMPV characterisation study. This underscores
the significant value HCTs can bring in providing rapid, high-quality efficacy
data to support vaccine and therapeutic development. hMPV currently has no
approved vaccine or therapeutic on the market, and hVIVO is proud to lead the
charge in helping our client bring medicines to the patients."

 

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, Camilla Hume, 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 / Phillip Marriage /               +44 (0)7980 541 893 / +44 (0)7867 984 082 /

Louis Ashe-Jepson
+44 (0)7747 515 393

 

 

Notes to Editors

 

hVIVO plc (https://hvivo.com/) (Ticker: HVO) is a rapidly growing early-stage
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://hlabservices.com/) brand.

 

Through its German subsidiary, CRS (https://crs-earlyphase.com/) , 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://www.vennlifesciences.com/) , 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://flucamp.com/) . Additionally, its five clinical sites support
outpatient Phase II and III trials, ensuring a seamless and efficient pathway
from discovery to late-stage development.

 

About hMPV

hMPV is a common virus that causes an upper respiratory infection, similar to
the common cold. Symptoms include cough, fever, nasal congestion, and
shortness of breath. Most people have mild cases of hMPV, but severe cases can
result in bronchiolitis, bronchitis and pneumonia. hMPV is associated with
approximately 20% of respiratory tract infections in children worldwide(1). Up
to 16% of the children infected with hMPV develop more severe symptoms(2),
with over 16,000 deaths worldwide in children under the age of five each
year.(3) Despite its prevalence and potential severity, there are currently
no vaccines or antivirals approved to treat hMPV.(4)

 

1.Science Direc
(https://www.sciencedirect.com/topics/immunology-and-microbiology/human-metapneumovirus)
t. 2. Howard LM, et al. 2021. 3 Wang X, et al. 2021. 4. CDC

 

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