Open Orphan PLC COVID-19 Human Challenge Programme update (4104T)
25 March 2021 - 6:00PM
UK Regulatory
TIDMORPH
RNS Number : 4104T
Open Orphan PLC
25 March 2021
25 March 2021
Open Orphan plc
("Open Orphan" or the "Company")
COV ID-19 Human Challenge Programme update
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
pharmaceutical services clinical research organisation (CRO) and
world leader in vaccine and antiviral testing using human challenge
clinical trials , announces an update in the world's first COVID-19
characterisation study. Following Research Ethics Committee
approval on 17 February 2021, hVIVO, a subsidiary of Open Orphan,
began the study at the Royal Free London NHS Foundation Trust
earlier this month.
The first three volunteers have now successfully completed the
quarantine phase of their study participation with no safety
concerns presented and have been discharged from the unit. The
study will now progress to the next group of volunteers. The first
three volunteers will continue their study participation with
follow up visits and monitoring for a period of up to one year. As
is normal practice during any clinical trial, none of the partners
in the study will be identifying any of the volunteers.
The virus characterisation study will inoculate up to 90
volunteers, between the ages of 18 and 30 years old, to enable
identification of the most appropriate dose of the virus needed to
cause COVID-19 (SARS-CoV-2) infection in a safe and controlled
environment. The study is funded by the UK Government and Imperial
College London is the clinical study sponsor. The study is
conducted by hVIVO at the Royal Free Hospital, under the scrutiny
of highly trained scientists and medics. The virus being used in
the characterisation study has been produced under hVIVO's
supervision by a team at Great Ormond Street Hospital for Children
NHS Foundation Trust in London, with support from virologists at
Imperial College London.
Individuals interested in taking part in this research can visit
www.UKCovidChallenge.com to learn more.
Chief Scientific Officer at hVIVO, Dr Andrew Catchpole, said :
"We are pleased to announce that the first three volunteers in this
world's first study have now successfully completed the quarantine
phase, these volunteers will continue to be monitored post-study
for up to 1 year. Throughout their stay at the Royal Free Hospital
in London, the volunteers are closely monitored by our highly
trained team of clinicians.
"We would like to thank these volunteers for their participation
in this important study and look forward to welcoming the following
cohorts. We expect that this study will greatly assist our
understanding of this disease and provide insights into its
progression, natural immune response, and transmission. We look
forward to publishing the study's results in due course and moving
forward with vaccine challenge studies later this year."
Dr Chris Chiu, Chief Investigator and Reader in Infectious
Disease at Imperial College London said: "We're pleased to confirm
the first group of three healthy volunteers has now successfully
completed the first stage of the trial, with no unexpected issues.
The volunteers are in good health. It would be premature to discuss
further details at this early stage."
Group Chief Executive at the Royal Free London, Caroline Clarke,
said: " We are incredibly proud to be working with our partners
from hVIVO, Imperial College London and the government's Vaccine
Taskforce on this important research. We're delighted that the
first stage of the study has been completed successfully and we
look forward to continuing our close collaboration as this research
moves forward."
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 ("MAR"). With the
publication of this announcement via a Regulatory Information
Service, this inside information is now considered to be in the
public domain.
For further information please contact:
Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser
and Joint Broker) +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer
/ Dan Gee-Summons
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 +44 (0)20 7933 8780 or openorphan@walbrookpr.com
& IR)
Anna Dunphy / Paul McManus +44 (0)7876 741 001 / +44
(0)7980 541 893
Notes to Editors
Open Orphan plc
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 which also has a highly specialised
virology and immunology laboratory on-site. Open Orphan has a
leading portfolio of eight human challenge study models for
conditions such as RSV, flu, asthma and COPD. In addition, Open
Orphan is also developing the world's first COVID-19 human
challenge study model as part of the Human Challenge Programme and
has signed a reservation contract with the UK Government for the
first three COVID-19 vaccine challenge 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. 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.
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