Open Orphan plc (LON:ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has announced that the results from the world’s first COVID-19 characterisation study have been peer reviewed and published in the scientific journal Nature Medicine.
‘Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge’ by Killingley, B. et al. is available in Nature Medicine, https://www.nature.com/articles/s41591-022-01780-9 DOI: 10.1038/s41591-022-01780-9
The study, which was conducted by hVIVO, a subsidiary of Open Orphan, in partnership with Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust, showed that the SARS-CoV-2 human challenge was safe in healthy young adults and provided detailed insights into the course of COVID-19 infection with potential positive public health implications. The study results had previously been published on Research Square whilst the peer review process was concluding.
As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that caused a safe and reliable infection in unvaccinated volunteers with no prior SARS-CoV-2 infection. hVIVO clinicians closely monitored volunteers in a controlled quarantined setting and collected disease progression data to provide insights into COVID-19 infection.
With the characterisation study disease modelling data completed, and a COVID-19 Human Challenge Model now established, Open Orphan should be able to contract / conduct COVID-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals.
Dr Andrew Catchpole, Co-investigator on the study and Chief Scientific Officer of hVIVO, said: “The SARS-CoV-2 characterisation study has provided invaluable insights into the progression of COVID-19 infection in healthy young adults. We are delighted to see the peer reviewed results published in Nature Medicine, which is one of the most influential and highly-cited medical research journals, and is an indication of how important the study was in helping deepen our understanding of SARS-CoV-2.”
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to see the characterisation study paper successfully complete the peer review process and be published in such a prestigious journal. Looking forward to the rest of the year, the COVID-19 human challenge model has the potential to accelerate the development of novel therapeutics and vaccines. We look forward to updating the market in due course.”
