TIDMORPH
RNS Number : 6843W
Open Orphan PLC
22 August 2022
Open Orphan plc
("Open Orphan" or the "Company")
GBP10.4m full-service contract signed with existing Big Pharma
client
hVIVO to develop new influenza challenge strain to test oral
antiviral candidate
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 hVIVO , a subsidiary of Open
Orphan, has signed a GBP10.4m contract with an existing top 5
global pharmaceutical client to manufacture a new batch of H1N1
influenza challenge virus, leveraging off an existing in-house
generated challenge model, and to conduct a human challenge trial
to test the client's antiviral product.
hVIVO has world-leading expertise in challenge agent
manufacture, with the ability to manufacture specific subtypes of
viruses, as well as unrivalled experience in conducting challenge
studies. Since the COVID-19 pandemic, the Company has seen an
increase in the number of clients looking to test their vaccines
and antivirals against specific subtypes of viruses that are
circulating in the population or that have the potential to be
widely spread. As a result, there is a greater interest in
end-to-end human challenge contracts such as this, that include a
novel challenge agent manufacture and a challenge study.
The study will evaluate the efficacy profile of the antiviral
against the specific influenza subtype, generating data quickly and
efficiently. This is the third human challenge contract signed with
this client, highlighting the Company's world leading expertise and
the clear benefits of human challenge trials to Big Pharma's drug
development process.
Good Manufacturing Practice ("GMP") compliant virus
manufacturing activities will commence immediately and are expected
to complete by Q2 2023. Once completed, hVIVO will conduct a Phase
2a double-blinded placebo-controlled human challenge study which is
expected to be completed by Q4 2023. hVIVO will recruit healthy
volunteers via the Company's dedicated volunteer recruitment arm,
FluCamp . The majority of revenue from the contract is expected to
be recognised during 2023.
Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said :
"We're delighted to be working again with this top 5 global
pharmaceutical company to test its antiviral, using a new influenza
strain developed by our highly experienced team. This contract is
the third challenge study with this client, and our second
end-to-end full-service contract overall. Our one-stop shop service
offerings from manufacturing bespoke challenge agents to conducting
full challenge studies is unique in the market. I am confident,
that with our highly qualified teams and their clinical development
expertise, we are well placed to address the growing infectious
disease and respiratory research markets.
"Influenza poses a serious global health threat, causing an
estimated 290,000 - 650,000 deaths per year with significant
pandemic potential, and as such, the development of new vaccines
and antivirals to fight flu remains vitally important."
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said:
"This contract is a strong example of where human challenge studies
can provide significant value. These studies can quickly and
cost-effectively generate efficacy data for our clients in specific
viral subtypes. As illustrated with this contract, our world-class
manufacturing capabilities can produce a challenge agent for
subtypes that pose a particular global health risk or are already
circulating in the population. The resulting data can then indicate
whether the candidate is viable for Phase II/III studies, providing
substantial time and financial savings compared to traditional
field-based studies."
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.
For further information please contact:
Open Orphan plc +353 (0) 1 644 0007
Yamin Khan, Chief Executive Officer
Liberum Capital (Nominated Adviser
and Joint Broker) +44 (0) 20 3100 2000
Ben Cryer/ Edward Mansfield/ Phil
Walker/ Will King
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
Stephanie Cuthbert / Phillip +44 (0) 7796 794 663 / +44 (0) 7867 984
Marriage / 082 /
Louis Ashe-Jepson +44 (0) 7747 515 393
Notes to Editors
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.
About Influenza (flu)
Influenza (flu) is a contagious respiratory illness caused by
influenza viruses that infect the nose, throat, and lungs. Seasonal
influenza causes significant morbidity and mortality each year and
a pandemic influenza continues to pose a worldwide threat.
Influenza is a serious global health threat with an estimated 1
billion cases per year, 3-5 million severe cases and 290,000 -
650,000 deaths per year. Healthy volunteer human challenge studies
of wild-type influenza play a major role in the development of
vaccines and therapeutics against influenza.
H1N1 is a subtype of the influenza A virus and have caused two
pandemic outbreaks, including the 1918 Spanish flu and the 2009
swine flu pandemic.
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