Open Orphan plc

("Open Orphan" or the "Company")

£6.2m Influenza human challenge study contract win

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 hVIVO, a subsidiary of Open Orphan plc, has signed a £6.2m contract with a US-based biotechnology company to test its antiviral candidate using the hVIVO Influenza A human challenge study model.

The human challenge study is expected to commence in H2 2022 and will be conducted at hVIVO's state-of-the-art facilities in London. The Company expects the revenue from the contract to be recognised across 2022 and 2023.

The client has already published preliminary data to demonstrate a favourable pharmacokinetic and safety profile. This candidate exhibits a novel mechanism of action and differs from previously approved drugs. This is an ideal time in the development of this drug to conduct a challenge study.

This is the third significant influenza human challenge study contract that Open Orphan has signed in 2022, as attention switches to potential future outbreaks in this particular disease area. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 - 650,000 deaths per year.

hVIVO has three decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of influenza, respiratory syncytial virus (RSV) and human rhinovirus (HRV -  common cold virus), and asthma, as well as malaria. In June 2022, hVIVO announced that it is developing the world's first SARS-CoV-2 Omicron human challenge model.

Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said: "We are pleased to be working with this US-based client to test its exciting lead influenza antiviral using our Influenza human challenge study model. That the client has chosen us to run this study is testament to our position as the world leader in testing infectious and respiratory disease vaccines and antivirals using challenge studies. Furthermore, the contract underlines the increasing demand in the infectious disease clinical trial market, which is expected to grow to a value of over $5.5 billion by 2027.

"With this increasing demand in mind, we expect to continue to see our work coming from a broad range of infectious and respiratory diseases, and from companies ranging from smaller innovative biotechs to Big Pharma."

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). 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. 

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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, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, 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.