ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

COVID-19 Characterisation Study peer reviewed results published in industry leading periodical Nature Medicine

Data showed SARS-CoV-2 human challenge studies to be safe in healthy young adults

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces 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."

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

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Notes to Editors

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.