TIDMORPH
RNS Number : 0135Z
Open Orphan PLC
20 January 2022
20 January 2022
Open Orphan plc
("Open Orphan" or the "Company")
New Malaria Human Challenge Model Launched
First volunteers inoculated with Malaria human challenge
virus
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
contract research organisation (CRO) and world leader in vaccine
and antiviral testing using human challenge clinical trials
announces that further to the announcement on 9 August 2021, hVIVO,
a subsidiary of Open Orphan, has inoculated the first cohort of
volunteers with a GMP-manufactured malaria challenge agent as part
of its first controlled human malaria infection (CHMI) challenge
study. This study will assess CHMI using existing standard of care
antimalarial drugs against
Plasmodium malaria.
The study, which is taking place at hVIVO's state-of-the-art
facilities in London, is expected to complete in Q1 2022 with
results in Q2 2022. For the study, hVIVO has leveraged its
extensive experience in clinical trial recruitment, via its
clinical trial recruitment arm FluCamp, to identify and screen
volunteers to rapidly enrol the study cohort. Following the
successful completion of the study, hVIVO will be able to sign
malaria human challenge study contracts to assess the efficacy of
novel antimalarial drugs and vaccines as well as correlates
of immunity using a Plasmodium challenge agent.
hVIVO's Direct Venous Inoculation ("DVI") clinical trial
protocol was reviewed by all necessary UK regulatory bodies and
fully approved prior to the start of the study. Expert diagnostic
services from the London School of Hygiene and Tropical Medicine
have been contracted to monitor the welfare of subjects and provide
essential correlates relating to drug and vaccine efficacy.
Additionally, comprehensive training programmes have been completed
by staff and senior professional oversight put in place for the
review of scientific and safety data.
This malaria challenge model consists of inoculating volunteers
with purified, infectious P. falciparum (Pf) sporozoites, harvested
from the salivary glands of Anopheles stephensi mosquitoes. This
type of malaria challenge model has been safely used in multiple
clinical trials in the United States, Europe and Africa.
Conducting malaria modelling with Plasmodium in antimalarial
drug and vaccine trials has several potential advantages over
traditional methods of P. falciparum infected mosquito challenge,
including superior predictability, a cleaner safety profile and
improved control over levels of infection.
Learn more about hVIVO's Malaria human challenge model here
www.hvivo.com/clinical-development-services/hvivo-challenge-models/malaria/
or if you are interested in participating in a Malaria human
challenge study or any other human challenge study visit
www.flucamp.com
Adrian Wildfire, Director of Scientific & Business Strategy
at hVIVO, said: " Malaria is a disease of significant unmet need
around the world, with 241 million cases and 627,000 deaths caused
in 2020. Its prevention and cure is a designated World Health
Organization target. As such, we are pleased to have commenced this
study to allow our clinical teams to better acquaint themselves
with the recently established Controlled Human Malaria Infection
model, ahead of using human challenge studies to test our clients'
malaria products. Data resulting from such studies translates well
into the field and malaria human challenge studies have been
pivotal to the development of many of the novel drugs now entering
late phase trials. "
Cathal Friel, Executive Chairman of Open Orphan, said : "We are
delighted to have inoculated the first cohort of volunteers for the
Malaria study at our QMB facility in London. hVIVO is fully
committed to growing the malaria model's capabilities and capacity
over the coming years to meet the challenge of accelerating the
introduction of novel, safe and effective drugs and vaccines to the
market.
"This study also ensures that Open Orphan is both strengthening
and further diversifying the Company's world leading portfolio of
viral challenge models. 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.
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 / 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 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 organisation 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. Open Orphan has a leading portfolio of
human challenge study models for infectious and respiratory
diseases and is developing a number of other models. There has been
an explosion in the growth of the infectious disease
pharmaceuticals 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.
About Malaria
Malaria is a serious and life-threatening disease prevalent
across much of tropical and sub-tropical Asia, South America and
Sub-Saharan Africa. Due to increasing resistance to current
antimalarial regimens, new drugs are required as both stand-alone
and partner therapies to address a growing unmet medical need. In
addition, novel combinations of existing drugs may be required to
fill the gap until pipeline candidates can be safely progressed to
market. New drugs and combination therapies are required to not
only reduce mortality and morbidity in susceptible, primarily
paediatric populations, but also to help the move towards a greater
goal of malaria elimination.
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