Open Orphan PLC (ORPH.L) NEJM Opinion Piece

The New England Journal of Medicine (NEJM) publishes editorial relating to

Human Challenge Programme

Open Orphan (AIM: ORPH), a rapidly growing specialist clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, confirms that an editorial opinion piece regarding the UK Government’s Human Challenge Programme has been published in the latest edition of the New England Journal of Medicine (NEJM).

The piece, titled ‘Establishing the Model during an Evolving Pandemic’, explores the extensive preliminary review process which was commissioned by the UK Government and delivered by the coalition involved in the COVID-19 Human Challenge Programme to justify the research and manage and minimise the risks associated with the trial, as well as arguments supporting the inclusion of a SARS-CoV-2 human challenge research program as part of the pandemic response.

The Human Challenge Programme, part of the UK Government’s Vaccine Taskforce, is a collaboration between the UK Government, the Royal Free London NHS Foundation Trust, Imperial College London and hVIVO , a subsidiary of Open Orphan, to deliver the world’s first human challenge study for COVID-19.

In human challenge studies, a small number of healthy volunteers in a controlled setting are exposed to an infectious agent, in this instance, COVID-19, for scientists and clinicians to assess how effective vaccines or treatments are against the disease and identify any side effects.

The NEJM is recognised as the world’s leading medical journal and website. Published continuously for over 200 years, the NEJM delivers high-quality, peer-reviewed research and interactive clinical content to physicians, educators, researchers, and the global medical community. The publication’s mission is to publish the best research and information at the intersection of biomedical science and clinical practice and to present this information in understandable, clinically useful formats that inform health care practice and improve patient outcomes.

Cathal Friel, Executive Chairman of Open Orphan plc, commented: “We are delighted to see support for the COVID-19 Human Challenge Programme in a publication such as the New England Journal of Medicine. The piece articulates the considerable review process commissioned by the UK Government and delivered by hVIVO, in collaboration with the Royal Free London NHS Foundation Trust , and Imperial College London. We believe the UK Government’s COVID-19 Human Challenge Programme will play a vital role in trialling the vaccines and antivirals which continue support our effective pandemic response in the UK and abroad. ”

For further information please contact:

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Notes to Editors

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

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of eight human challenge study models for infectious and respiratory diseases and is developing a number of other models including the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme .

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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts .

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