TIDMORPH
RNS Number : 6769G
Open Orphan PLC
31 March 2022
Open Orphan plc
("Open Orphan" or the "Company")
COVID-19 Characterisation Study peer reviewed results published
in industry leading periodical Nature Medicine
Data showed SARS-CoV-2 human challenge studies to be safe in
healthy young adults
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 the results from the world's first
COVID-19 characterisation study have been peer reviewed and
published in the scientific journal Nature Medicine.
'Safety, tolerability and viral kinetics during SARS-CoV-2 human
challenge' by Killingley, B. et al. is
available in Nature Medicine, https://www.nature.com/articles/s41591-022-01780-9 DOI: 10.1038/s41591-022-01780-9
The study, which was conducted by hVIVO, a subsidiary of Open
Orphan, in partnership with Imperial College London, the Vaccine
Taskforce and Department of Health and Social Care (DHSC), and the
Royal Free London NHS Foundation Trust, showed that the SARS-CoV-2
human challenge was safe in healthy young adults and provided
detailed insights into the course of COVID-19 infection with
potential positive public health implications. The study results
had previously been published on Research Square whilst the peer
review process was concluding.
As part of the characterisation study, researchers aimed to
identify a dose of COVID-19 that caused a safe and reliable
infection in unvaccinated volunteers with no prior SARS-CoV-2
infection. hVIVO clinicians closely monitored volunteers in a
controlled quarantined setting and collected disease progression
data to provide insights into COVID-19 infection.
With the characterisation study disease modelling data
completed, and a COVID-19 Human Challenge Model now established,
Open Orphan should be able to contract / conduct COVID-19 human
challenge studies in 2022, subject to individual ethics and
regulatory approvals.
Dr Andrew Catchpole, Co-investigator on the study and Chief
Scientific Officer of hVIVO, said : "The SARS-CoV-2
characterisation study has provided invaluable insights into the
progression of COVID-19 infection in healthy young adults. We are
delighted to see the peer reviewed results published in Nature
Medicine, which is one of the most influential and highly-cited
medical research journals, and is an indication of how important
the study was in helping deepen our understanding of
SARS-CoV-2."
Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said:
"I am pleased to see the characterisation study paper successfully
complete the peer review process and be published in such a
prestigious journal. Looking forward to the rest of the year, the
COVID-19 human challenge model has the potential to accelerate the
development of novel therapeutics and vaccines. We look forward to
updating the market in due course."
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.
For further information please contact:
Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Yamin Khan, Chief Executive Officer
Arden Partners plc (Nominated Adviser
and Joint Broker) +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson / Richard
Chambers
Davy (Euronext Growth Adviser and
Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Sam Allen / Louis +44 (0)7980 541 893 / +44 (0) 7502 558
Ashe-Jepson 258 / +44 (0)
7747 515393
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 and is developing a
number of new models, such as malaria and COVID-19, 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(R) platform, this unique dataset includes clinical,
immunological, virological, and digital (wearable) biomarkers.
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