ORPH.L Regulatory News (ORPH)

25 March 2021

Open Orphan plc

("Open Orphan" or the "Company")

COVID-19 Human Challenge Programme update

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 an update in the world's first COVID-19 characterisation study. Following Research Ethics Committee approval on 17 February 2021, hVIVO, a subsidiary of Open Orphan, began the study at the Royal Free London NHS Foundation Trust earlier this month.

The first three volunteers have now successfully completed the quarantine phase of their study participation with no safety concerns presented and have been discharged from the unit. The study will now progress to the next group of volunteers. The first three volunteers will continue their study participation with follow up visits and monitoring for a period of up to one year. As is normal practice during any clinical trial, none of the partners in the study will be identifying any of the volunteers.

The 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 funded by the UK Government and Imperial College London is the clinical study sponsor. The study is conducted by hVIVO at the Royal Free Hospital, 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.

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

Chief Scientific Officer at hVIVO, Dr Andrew Catchpole, said: "We are pleased to announce that the first three volunteers in this world's first study have now successfully completed the quarantine phase, these volunteers will continue to be monitored post-study for up to 1 year. Throughout their stay at the Royal Free Hospital in London, the volunteers are closely monitored by our highly trained team of clinicians.

"We would like to thank these volunteers for their participation in this important study and look forward to welcoming the following cohorts. We expect that this study will greatly assist our understanding of this disease and provide insights into its progression, natural immune response, and transmission. We look forward to publishing the study's results in due course and moving forward with vaccine challenge studies later this year."

Dr Chris Chiu, Chief Investigator and Reader in Infectious Disease at Imperial College London said: "We're pleased to confirm the first group of three healthy volunteers has now successfully completed the first stage of the trial, with no unexpected issues. The volunteers are in good health. It would be premature to discuss further details at this early stage." 

Group Chief Executive at the Royal Free London, Caroline Clarke, said: "We are incredibly proud to be working with our partners from hVIVO, Imperial College London and the government's Vaccine Taskforce on this important research. We're delighted that the first stage of the study has been completed successfully and we look forward to continuing our close collaboration as this research moves forward."

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.