hVIVO plc (LON:HVO), (formerly Open Orphan plc) a rapidly growing specialist contract research organisation and world leader in testing infectious and respiratory disease products using human challenge clinical trials, is developing a human metapneumovirus (hMPV) challenge model. hVIVO has signed an agreement with a North American biopharmaceutical company to manufacture a hMPV virus and conduct a characterisation study, with the intent to conduct a subsequent hMPV challenge trial in 2024 to test the efficacy of its vaccine candidate.
hVIVO will commence Good Manufacturing Practice (GMP) compliant virus manufacturing activities immediately and this is expected to complete in H1 2024. The Company will then conduct a characterisation study to identify a safe and infectious dose of wild-type hMPV in up to 36 healthy adult volunteers. Dependent on the successful completion of the characterisation study and receipt of relevant regulatory approvals, the Company expects to conduct hMPV challenge trials from H2 2024. The majority of the revenue from this end-to-end human challenge service will be recognised in 2024.
The client intends to utilise the efficacy data from the challenge study to define the endpoints for its hMPV vaccine candidate’s clinical development programme, as well as providing a greater understanding of virus progression, aiding dosing decisions and confirming previous animal study results. This will allow the client to streamline future trials and make critical go/no-go decisions more quickly, therefore accelerating the development of the vaccine candidate.
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 worldwide1. Up to 16% of the children infected with hMPV develop more severe symptoms2, 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
Yamin ‘Mo’ Khan, Chief Executive Officer said: “We are delighted to be developing the industry’s first commercial hMPV human challenge model. The continued expansion of our challenge model portfolio aligns with our mission to deliver today’s healthcare by empowering tomorrow’s innovation. We hope to help our client to bring their treatment to patients faster through the utilisation of a new unique human challenge model. We will continue to expand our library of challenge models and provide a mechanism for our customers to expedite their drug development.”
Dr Andrew Catchpole, Chief Scientific Officer said: “hVIVO’s unique expertise and world leading capabilities enables us to provide our clients with a full human challenge service offering, including the development of bespoke challenge models. As demonstrated with RSV, hVIVO can also play a vital role in speeding up drug development for hMPV, which currently has no approved vaccine or antiviral treatment.”
1 https://www.sciencedirect.com/topics/immunology-and-microbiology/human-metapneumovirus
2 Howard LM, et al. 2021
3 Wang X, et al. 2021
4 CDC
