ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

Ethics Approval Granted for COVID-19 Human Challenge Study Model 

Call for volunteers to enrol in studies that will play a key part in developing effective vaccines and treatments for COVID-19

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces the world's first COVID-19 characterisation study has received approval from a specially convened Research Ethics Committee ("REC"). This news follows the announcement on 20 October 2020 of Open Orphan subsidiary hVIVO's contract with the UK Government to develop a COVID-19 human challenge study model.

The initial virus characterisation study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2) infection in a safe and controlled environment. The study is set to commence shortly and is funded by the UK Government. Imperial College London is the clinical study sponsor and the study will be conducted by hVIVO at the Royal Free London NHS Foundation Trust's specialist clinical research unit, under the scrutiny of highly trained scientists and medics. The virus being used in the characterisation study has been produced under hVIVO's supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London.

The REC approval completes all the independent external body approvals required before the study can commence.

Individuals interested in taking part in this research can visit www.UKCovidChallenge.com to learn more.

Chief Scientific Officer, hVIVO, Dr Andrew Catchpole, said: "Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the COVID-19 challenge model. COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic.

"This study is a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required. Data from this study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection."

Dr Chris Chiu, Clinical Reader, Honorary Consultant and Chief Investigator of this study said: "The recent worsening of the pandemic and urgent need to vaccinate people quickly and effectively have raised new questions about COVID-19 and how to best protect ourselves against it. This study will immediately tell us about mild and asymptomatic infection, which is a major driver of continuing transmission. While the first wave of vaccines are being rolled out, human challenge studies could also be pivotal in helping to shape the timings and doses of existing vaccines, finding out how long one dose is protective for, and if they are effective against new variants of the virus."

"The Research Ethics Committee has provided detailed independent scrutiny. Their favourable opinion is a crucial step towards getting this study open and running, and greatly helps us in our efforts to minimise risks and enhance the quality of the research."

Cathal Friel will be presenting at a Mello event on Monday, 22 February. To register for this, please follow the link: https://melloevents.com/mellomonday-22nd-february-2021/

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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Notes to Editors

Open Orphan plc

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 which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world's first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. 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.

Health Research Authority (HRA)

Before commencing a clinical study, researchers must submit an application for Health Research Authority (HRA) approval which brings together the assessment of governance and legal compliance, with the independent Research Ethics Committee (REC) opinion to confirm whether a research study has all the necessary approvals in place from the relevant bodies to proceed. The HRA, as the body responsible for running the UK Research Ethics Service, brought together a group of experienced REC members from around the UK to review the COVID-19 challenge study. The specially convened committee was made up of 12 members, a mixture of lay people and experts as required by law and has been recognised by UKECA (The United Kingdom Ethics Committee Authority).