TIDMORPH
RNS Number : 6879E
Open Orphan PLC
09 July 2021
9 July 2021
Open Orphan plc
("Open Orphan" or the "Company")
Significant HRV & Influenza human challenge study contract
win
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 that hVIVO, a subsidiary of Open Orphan
plc, has signed a significant contract with AIM ImmunoTech Inc
("AIM IT") to test its antiviral candidate, Ampligen, using both
the human Rhinovirus HRV (common cold virus) and Influenza human
challenge study models as part of a single study.
This antiviral study will be conducted by hVIVO. AIM IT will be
the study sponsor of the Phase 2 human challenge trial, which is
expected to commence in Q4 2021. The Company expects the majority
of revenue from the contract to be recognised in the current
financial year. The AIM IT contract demonstrates the breadth of
Open Orphan's service offering and its ability to test multiple
pathogens at once in its state-of-the-art zoned unit, reinforcing
its status as the world leader in its field. The Company expects to
sign more contracts in this area due to the increased international
focus on respiratory and infectious diseases following the outbreak
of COVID-19 and as attention turns to potential future outbreaks of
other viral diseases.
hVIVO has two decades of experience and expertise in safely
conducting challenge studies across a range of respiratory viruses,
including various strains of Influenza, Respiratory Syncytial Virus
(RSV) and human Rhinovirus HRV (common cold virus). In October
2020, this expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said : "We are
delighted to commence work with AIM ImmunoTech, a leading
immuno-pharma company, to test their product against both HRV and
Influenza human challenge study models as part of a single study.
Being able to test our client's product against multiple pathogens
in a single study demonstrates our capability of our
state-of-the-art London unit, our industry leading experience, and
our position as the go to provider of human challenge studies for
biotech and pharmaceutical companies globally. Fortunately, with
our access to three challenge study clinics in London, we were able
to find a small gap in our schedule later this year to slot this
particular study in at short notice.
"Likewise, as previously confirmed to the market, our London
facilities are comprehensively prebooked throughout this year and
into next year. As such, I am also delighted to confirm that we
were solidly EBITDA profitable in H1 2021 and we remain on target
for a profitable and successful 2021."
Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech
Inc., said: "It is our belief that Ampligen's mechanism of action
regarding the human innate immune system gives Ampligen
broad-spectrum capabilities as an antiviral prophylaxis and
therapeutic. The ability to do a human challenge trial using HRV
and Influenza allows us to test in humans Ampligen's potential role
as a powerful prophylaxis and therapeutic for a wide range of
respiratory viruses. It is our belief that if it works in these two
viruses, then it will have the potential to have a similar impact
in other respiratory viruses."
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.
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.
Individuals interested in taking part in COVID-19 human
challenge study research can learn more at www.UKCovidChallenge.com
.
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 / Richard Johnson
/ Oscair McGrath
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)
Paul McManus/ Sam Allen/ Louis Ashe-Jepson +44 (0)7980 541 893 / +44
(0) 7502 558 258 / +44 (0)
7747 515393
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.
AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the
research and development of therapeutics to treat multiple types of
cancers, immune disorders, and viral diseases, including COVID-19,
the disease caused by the SARS-CoV-2 virus.
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