TIDMORPH
RNS Number : 3895A
Open Orphan PLC
02 February 2022
2 February 2022
Open Orphan plc
("Open Orphan" or the "Company")
Results from the world's first COVID-19 Characterisation
Study
Data shows SARS-CoV-2 human challenge studies are 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 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 (DHSC), and the Royal Free
London NHS Foundation Trust. The results from this landmark study,
show that a SARS-CoV-2 human challenge is safe in healthy young
adults and provide detailed insights into the course of COVID-19
infection with potential positive public health implications.
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. The results published today detail the outcome of the 36
healthy male and female volunteers aged 18-29 years which were
infected with the original SARS-CoV-2 strain challenge virus. hVIVO
clinicians closely monitored volunteers in a controlled quarantined
setting and collected disease progression data to provide insights
into COVID-19 infection. Volunteers will be followed up for 12
months after discharge from the quarantine facility.
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.
The characterisation study results and the insights they provide
into COVID-19 infection have potential implications for public
health. During the study, the average incubation period was 42
hours, which is considerably shorter than existing estimates of
five to six days. Results also showed that while virus was detected
significantly earlier in the throat, peak levels of virus were far
higher in the nose, implying a potentially higher risk of viral
shedding from the nose. This underlines the importance of proper
facemask use to cover both the mouth and nose. Additionally,
insights into the timeline of infection, with viable virus seen
after nine days and 12 days for some, support the isolation periods
advocated in most guidelines.
Lateral flow tests (LFTs) were also shown to be a good indicator
of whether someone was harbouring viable virus. Positive LFTs
correlated well with lab-confirmed detection of virus from swabs
throughout the course of infection, including in those who were
asymptomatic. However, the tests were less effective in picking up
lower levels of virus at the very start and end of infection.
The challenge virus used in the study was 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. The Human Challenge Programme is funded by
the UK Government, who commissioned Imperial College London to act
as the clinical study sponsor. The study was conducted by hVIVO at
the Royal Free Hospital, under the supervision of the Company's
highly trained scientists and medics.
Cathal Friel, Executive Chairman of Open Orphan, said : "I am
delighted that the world's first COVID-19 characterisation study
has completed with no serious adverse events or serious symptoms,
demonstrating that a COVID-19 human challenge study is safe in
healthy young adults. The results, which have been made public
today, have provided invaluable insights into COVID-19 disease
progression.
"Crucially, we have now successfully established a COVID-19
Human Challenge Model which could be instrumental in accelerating
the development of future COVID-19 therapeutics. New variants, such
as Omicron, often mean that vaccines and antivirals have to be
quickly re-evaluated to ensure effectiveness. Human challenge
studies could prove to be the fastest way to compare old and new
vaccines and therapies."
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.
Importantly the study demonstrated that SARS-CoV-2 challenge
studies are safe and well tolerated by the volunteers with no
serious symptoms and no Serious Adverse Events (SAEs). The study's
results have provided useful insights which could be used to inform
public health decisions on COVID-19 symptoms and virus detection
going forward, including isolation periods for infectious
individuals, the use of LFTs, and establishing the human challenge
platform to investigate further aspects of COVID-19.
"While the characterisation study was focused on the original
SARS-CoV-2 strain, and there are differences in transmissibility
between it and the other variants, the same factors will be
responsible for protection against it, meaning the findings remain
valuable for variants such as Delta or Omicron. These data provide
a clear platform to now utilise the human challenge model to
expedite product efficacy testing for new vaccines or
antivirals"
Professor Christopher Chiu, Professor of Infectious Diseases
from the Institute of Infection at Imperial College London and
Chief Investigator on the trial, said: "First and foremost, we've
shown that our challenge infection model was safe and well
tolerated in healthy young adult participants. People in this age
group are believed to be major drivers of the pandemic and these
studies, which are representative of mild infection, allow detailed
investigation of the factors responsible for infection and pandemic
spread.
"Our study reveals some very interesting clinical insights,
particularly around the short incubation period of the virus,
extremely high viral shedding from the nose, as well as the utility
of lateral flow tests, with potential implications for public
health."
Professor Sir Jonathan Van-Tam, Deputy Chief Medical Officer at
Department of Health and Social Care, said: "Human challenge
studies have been performed using other pathogens for decades,
including flu and Respiratory Syncytial Virus (RSV). They need full
independent ethical review and very careful planning - as has been
the case this time. Every precaution is taken to minimise risk.
"Scientifically these studies offer real advantage because the
timing of exposure to the virus is always known exactly, therefore
things like the interval between exposure and the profile of virus
shedding can be accurately described.
"This important study has provided further key data on COVID-19
and how it spreads, which is invaluable in learning more about this
novel virus, so we can fine-tune our response. Challenge studies
could still prove to be important in the future to speed the
development of 'next-generation' Covid-19 vaccines and antiviral
drugs.
"This data underline just how useful a tool lateral flow tests
can be to pick up people when infectious and the importance of
wearing a face covering in crowded, enclosed spaces."
Dr Mariya Kalinova, Principal Investigator on the study and
Medical Director of hVIVO, said: "Closely observing and examining
COVID-19 infection disease progression in volunteers during the
SARS-CoV-2 characterisation study has revealed several important
insights which will benefit public health going forward. Results
uncovered new insights into the average incubation period for
COVID-19 infection as well as disparities in viral loads between
the nose and mouth, which endorses proper mask wearing guidance.
Most importantly, there were no serious or adverse events, which
proves a SARS-CoV-2 challenge is safe and well tolerated."
Dr Sir Michael Jacobs, consultant in infectious diseases at the
Royal Free London, said: "We have vast experience of safely
managing highly transmissible infections at the Royal Free Hospital
and we are really pleased to have been able to play our part in
this landmark study.
"The trial has already provided some fascinating new insights
into SARS-CoV2 infection, but perhaps its greatest contribution is
to open up a new way to study the infection and the immune
responses to it in great detail and help test new vaccines and
treatments."
'Safety, tolerability and viral kinetics during SARS-CoV-2 human
challenge' by Killingley, B. et al. is
available on the Research Square pre-print server and has been submitted for peer-review. DOI: 10.21203/rs.3.rs-1121993/v1 https://www.researchsquare.com/article/rs-1121993/v1
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.
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) ("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 / 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
Virus: The challenge virus used was a pre-Alpha strain of
SARS-CoV-2, from the B1 lineage, which includes the Alpha, Beta and
Delta variants (first detected in England (Kent), South Africa and
India, respectively). It contained the D614G mutation in the spike
protein, which is believed to have increased transmissibility
compared to the originally described strain. The study used virus
from very early in the pandemic obtained from a hospitalized
patient in the ISARIC4C study.
Viral load: Swabs were taken from participants' nose and throat
twice a day. Viral replication was detected using PCR analysis and
lab cultures, enabling analysis of viral load.
Open Orphan plc
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(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.
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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