ORPH.L Regulatory News (ORPH)

29 July 2021

Open Orphan plc

("Open Orphan" or the "Company")

Contract to support Phase II river blindness drug trial

Antibiotic drug study for the treatment of the second-most common cause of blindness due to infection

Open Orphan plc (AIM: ORPH), a rapidly growing specialist clinical research organisation (CRO) which is the world leader in testing vaccines and antivirals using human challenge clinical trials, announces a contract to supply consultancy services to support a Phase II trial in Onchocerciasis Disease, an infectious disease commonly known as river blindness.

Venn Life Sciences ("Venn"), a subsidiary of Open Orphan, will provide Data Management & Biostatistics services to support the Phase II trial of an antibiotic drug candidate for Drugs for Neglected Diseases initiative ("DNDi"), a not-for-profit research organisation developing new affordable and patient-friendly treatments for neglected patients around the world. DNDi was founded in 2003 by Médecins Sans Frontières, the World Health Organisation, and five international research institutions.

The Venn team in the Paris office will provide support for the trial, taking place in the Democratic Republic of Congo, to evaluate the product ABBV-4083, owned by AbbVie and licensed to DNDi, as a potential antibiotic treatment for patients with Onchocerciasis, the second-most common cause of blindness due to infection, after trachoma. ABBV-4083 was identified by a screening of anti-infective compounds led by the pharmaceutical company AbbVie and the anti-Wolbachia consortium A-WOL at the Liverpool School of Tropical Medicine. The study has already commenced.

Venn offers a unique set of high quality, innovative, methodology, data management and biostatistics services utilising the very best technologies and clinical trial expertise to help their clients have access to their data faster and at a lower cost. Venn's portfolio of services range from design conception, through to data-acquisition and management activities to the analysis, reporting and exploitation of the results and their subsequent presentation for submission to the appropriate regulatory authorities and/or publication. Venn offer a fully standardised and compliant methodology for collating, validating and presenting real-time information to their clinical partners.

Cathal Friel, Executive Chairman of Open Orphan, said: "We are delighted to announce another contract win for the business which underpins our confidence in the continued growth we expect to see in 2021. Our teams have a unique knowledge of multiple clinical data management systems and our team of biostatisticians have extensive experience to bring to bear on such studies. We're very proud to be working with DNDi to support their development of what could be a game-changing drug to help people affected by river blindness in some of the world's poorest nations."

Sabine Specht, Head of the Filarial Clinical Programme at DNDi, said: "We are delighted that Open Orphan has joined DNDi, AbbVie and multiple partners involved in the development of ABBV-4083 for those at risk or suffering from onchocerciasis. The Democratic Republic of Congo is one of the most affected countries by this debilitating disease, so it is especially important that our clinical trials will take place there, where we will be working with national authorities to test out this potentially innovative treatment."

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 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.