Open Orphan PLC (ORPH.L) £5.1m RSV Human Challenge Study Contract Win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan.

Has signed a £5.1m contract with a biopharmaceutical company to test its Investigational Medicinal Product (IMP) using hVIVO’s respiratory syncytial virus (RSV) Human Challenge Study Model.

The study is due to commence in H2 2022, with the revenue from the contract being recognised across 2021 and 2022. hVIVO will conduct this study on behalf of this biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection.

RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan said: “We are pleased to have signed this contract to test our client’s product using our RSV Human Challenge Study Model. It is testament to our position as the world leading provider of Phase IIa human challenge study clinical trials that innovative biopharmaceutical companies, as well as Big Pharma, are actively and regularly engaging us to test their novel vaccine and antiviral candidates.

“RSV is one of several infectious and respiratory disease areas of unmet need that we are seeing rapidly growing interest in from drug developers. We look forward to working with more companies across the world to test their antivirals and vaccines, as Phase IIa human challenge studies increasingly become part of mainstream clinical trial design.”

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 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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.

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

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 and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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.

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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