hVIVO PLC Develops hMPV Human Challenge Model
hVIVO plc, a leader in testing infectious and respiratory disease products through human challenge clinical trials, is developing a human metapneumovirus (hMPV) challenge model. This development follows an agreement with a North American biopharmaceutical company to manufacture the hMPV virus and conduct a characterisation study, with a subsequent challenge trial planned for 2024 to test a vaccine candidate's efficacy.
hVIVO will start Good Manufacturing Practice (GMP) compliant virus manufacturing activities immediately, expected to complete in the first half of 2024. A characterisation study will then identify a safe and infectious dose of wild-type hMPV in up to 36 healthy adult volunteers. Subject to the study's success and regulatory approvals, hMPV challenge trials are anticipated to begin in the second half of 2024, with the majority of revenue from this service recognized in the same year.
The client plans to use the challenge study's efficacy data to define endpoints for its hMPV vaccine candidate’s clinical development programme, enhancing understanding of virus progression, aiding dosing decisions, and confirming previous animal study results. This approach aims to streamline future trials and accelerate vaccine development.
hMPV causes upper respiratory infections with symptoms like cough, fever, nasal congestion, and shortness of breath. While most cases are mild, severe instances can lead to bronchiolitis, bronchitis, and pneumonia. hMPV is responsible for about 20% of respiratory tract infections in children globally, with severe symptoms in up to 16% of cases and over 16,000 deaths annually in children under five. Despite its prevalence and severity, there are no approved vaccines or antivirals for hMPV.
Yamin ‘Mo’ Khan, CEO of hVIVO, expressed enthusiasm for developing the industry’s first commercial hMPV human challenge model, aligning with the company's mission to empower healthcare innovation. Dr. Andrew Catchpole, Chief Scientific Officer, highlighted hVIVO's unique expertise in providing a full human challenge service, including bespoke model development, to expedite drug development for hMPV.