Cathal Friel of Open Orphan discusses the results from the world's first COVID-19 Characterisation Study

Cathal Friel, Executive Chairman of Open Orphan #ORPH discusses the results from the world's first COVID-19 Characterisation Study which was a partnership between hVIVO, Imperial College London, the Vaccine Taskforce and Department of Health and Social Care and the Royal Free London NHS Foundation Trust.

The key clinical insights were as follows:

Viral load ("VL")

·    18 volunteers (50%) became infected with viral load (VL) rising steeply and peaking at ~five days post-inoculation

·    No quantitative correlation was noted between VL and symptoms

Symptoms

·   No serious symptoms

·   Mild-to-moderate cold like symptoms were reported by 16 (88%) of 18 infected volunteers including a stuffy or runny nose, sneezing, and a sore throat. Some experienced headaches, muscle/joint aches, tiredness and fever

·    Anosmia (lost or changed sense of smell) occurred in 13 (72% of infected) volunteers

Virus detection

·    Average time from first exposure to viral detection and early symptoms (incubation period) was 42 hours

·    Virus was detected earliest in the throat but at significantly greater levels in the nose;

o  Virus detected in the throat on average after 40 hours

o  Virus detected in the nose on average after 58 hours

·    High levels of viable (infectious) virus was seen for approximately nine days post-inoculation, and up to a maximum of 12 days

·    Modelling using the study data indicated that regular asymptomatic lateral flow testing ("LFT") would diagnose infection before 70-80% of infectious virus had been generated, thus if isolation was triggered would decrease community transmission to others

Importantly, no serious adverse events (SAEs) occurred, and the SARS-CoV-2 human challenge study model was shown to be safe and well tolerated in healthy young adults. With the characterisation study disease modelling data completed, and a COVID-19 Human Challenge Model now established, the Company should be able to contract / conduct COVID-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals. The Company is already developing a Delta strain of the COVID-19 virus in partnership with Imperial College London and funded by the Wellcome Trust, which could be used in future trials.

The data published today supports the safety of the infection challenge model which could theoretically provide a 'plug and play' platform for testing therapies and vaccines using the original COVID-19 strain as well as variants of the virus.

About Open Orphan

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing 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. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease 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.