LIVERPOOL, England,
July 7, 2020 /PRNewswire/ -- The
University of Liverpool, Liverpool
School of Tropical Medicine, and Southampton Clinical Trials Unit
announced this week that they have launched their innovative
COVID-19 drug testing platform, AGILE. The AGILE initiative is a
collaboration between the University of
Liverpool, Liverpool School of Tropical Medicine,
Southampton Clinical Trials Unit, University of Southampton, and
Lancaster University, as well as
other partners. AGILE has been developed by Infectious Diseases
clinicians, clinical and pre-clinical pharmacologists, clinical
trials specialists and statisticians. The result is a clinical
trials platform that can test new drugs for COVID-19 and identify
faster than ever before those compounds which could be game
changers in the battle against COVID-19.
"In the ongoing COVID-19 pandemic, we need to find innovative
ways to identify safe and effective treatments as soon as possible.
The AGILE platform bridges the gap between pre-clinical drug
discovery and large-scale testing, rapidly identifying drugs that
have the best chance of success," says Professor Saye Khoo, Chief Investigator on AGILE at the
University of Liverpool. "Seeing the
launch of this new platform to test brand new COVID-19 treatments
is truly exciting given the impact that any effective treatment
could have on the pandemic and restarting society. We are
optimistic that AGILE will accelerate the development of treatments
for COVID-19, and also prepare us to respond quicker to future
pandemics."
AGILE is a "proof of confidence engine" that can treat COVID-19
patients for the first time with promising drugs that have been
developed in laboratories around the world. The trial is conducted
at the Royal Liverpool University
Hospital Clinical Research Unit, where treatment is carefully
monitored throughout by an independent committee to ensure that it
is safe to continue, and the first evidence about the effectiveness
of the drug for treatment of COVID-19 is accumulated to determine
if it should be fast-tracked into large-scale trials. The design of
AGILE means that this can be achieved much more rapidly than when
using conventional development pathways for new drugs, so that
successful drugs can advance quickly enough to have an impact on
the current pandemic. AGILE is flexible and can test drugs that are
suitable for patients newly diagnosed with COVID-19 at home, as
well as patients in hospital.
The platform has full ethics and regulatory approval in the UK.
Dr Siu Ping Lam, Director of
Licensing, at the Medicines and Healthcare products Regulatory
Agency (MHRA), comments: "Patient safety is our highest priority.
We approved this trial, as it not only innovates in the early
clinical trial process, which is crucial in the current pandemic,
but it is also robust and safe, providing opportunities for more
rapid progress towards suitable treatment options. We are delighted
that such a platform, designed by UK clinicians and scientists, has
the potential to change the future of clinical trials and global
healthcare for the better."
The first drug set to be trialled in AGILE has been developed by
the US pharmaceutical company Ridgeback Biotherapeutics. EIDD-2801
is an oral antiviral drug that has shown promising results against
coronavirus infections in pre-clinical studies, and if successful
in human trials, could change the future of the pandemic. The team
at Ridgeback Biotherapeutics participated in the development and
design, as well as provided funding, for the EIDD-2801 arm of the
study.
The AGILE Initiative is made possible thanks to support provided
through a variety of donors. In addition to funding provided by
Unitaid and the Steve Morgan Foundation, some candidate-specific
trials will be funded directly and solely through independent
private companies (for example, Ridgeback Biotherapeutics).
Collaborative financial support has also been provided by the
Liverpool School of Tropical Medicine, University of Liverpool, and Southampton Clinical
Trials Unit as well as the NHS (Liverpool
University Hospitals NHS Foundation Trust). The partners
behind AGILE actively encourage other pharmaceutical companies and
academic institutions to put forward new COVID-19 treatment
candidates for consideration.
About AGILE
AGILE is a clinical trial platform that aims to speed up drug
testing in the ongoing pandemic and ultimately allow us to restart
society quicker. The platform uses adaptable protocols and
statistical models to design clinical trials in a fast and flexible
way that will simultaneously test safety and efficacy in people who
are ill. For further information on AGILE, please visit
www.agiletrial.net.
About University of
Liverpool
Associated with nine Nobel Laureates, the University is
recognised for its high-quality teaching and research. Our research
collaborations extend worldwide and address many of the grand
challenges facing humankind today.
About Liverpool School of Tropical Medicine
Liverpool School of Tropical Medicine (LSTM) is the world's
oldest centre of excellence in tropical medicine and international
public health. It has been engaged in the fight against infectious,
debilitating and disabling diseases since 1898 and continues that
tradition today with a research portfolio of over £320 million and
a teaching programme attracting students from over 65
countries.
About Southampton Clinical Trials Unit
Southampton Clinical Trials Unit (SCTU) is based at Southampton
General Hospital within the University of Southampton and is a UK
Clinical Research Collaboration registered Clinical Trials Unit.
SCTU receives CTU support funding from the National Institute for
Health Research, is core funded by Cancer Research UK and has
expertise in the development and co-ordination of clinical trials
from first-in-human to large practice changing phase III
trials.
About Lancaster
University
Lancaster is a
research-intensive university that combines world-class research
with excellent teaching and high levels of student satisfaction.
Lancaster University is among the
best in the UK. Top 10 in all three major national league tables,
it is also highly ranked in international league tables such as the
QS World Rankings, and it holds a Gold rating in the UK
government's Teaching Excellence Framework for the quality of its
teaching.
About Ridgeback Biotherapeutics LP
Ridgeback Biopharmaceuticals was co-founded by CEO Wendy Holman and Dr. Wayne Holman, a scientific advisor to the
company, with a focus on developing anti-viral medications for
diseases that have epidemic and pandemic risk. Ridgeback
Biotherapeutics is a majority woman-owned biotechnology company
which is dedicated to finding life-saving and life-changing
solutions for patients and diseases that need champions. Initial
funding for Ridgeback Biotherapeutics originated from Wayne and Wendy Holman; two individuals
committed to investing in and supporting technologies that will
make the world a better place.
About EIDD-2801
EIDD-2801 is an investigational, orally-bioavailable form of a
potent ribonucleoside analog that inhibits the replication of
multiple RNA viruses including SARS-CoV-2, the causative agent of
COVID-19. In animal studies of two distinct coronaviruses
(SARS-CoV-1 and MERS), EIDD-2801 has been shown to improve
pulmonary function, decrease body-weight loss and reduce the amount
of virus in the lung. EIDD-2801 was invented at Drug Innovations at
Emory (DRIVE), LLC, a not-for-profit
biotechnology company wholly owned by Emory
University.
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