Researchers in the UK have set up a drug testing platform to bridge the gap between preclinical testing and large-scale trials for drugs being tested to treat Covid-19.
The AGILE platform is a collaboration between the University of Liverpool, the Liverpool School of Tropical Medicine, and the Southampton Clinical Trials Unit that aims to speed up drug development in a pandemic situation without compromising patient safety.
“Conventional drug development is not designed for a pandemic – it is simply too slow,” Saye Khoo, Professor of Pharmacology and Therapeutics at the University of Liverpool and chief investigator for AGILE, told me.
“AGILE is designed to take potential candidates and evaluate them flexibly, rapidly and seamlessly to advance only those most plausible drugs into large scale clinical trials.”
The platform is designed to allow potential new drugs to go through the early testing stages in a matter of months rather than years. The UK Medicines and Health Regulatory Authority has evaluated and approved the use of the platform by Covid-19 drug developers.
“It can test several potential treatments in parallel and speeds up testing by pooling control patients,” explained Khoo. He added that AGILE uses a so-called ‘Bayesian adaptive’ statistical model that helps scientists running trials to make informed decisions about whether or not the development of a drug should continue or not.
“The safety of the AGILE platform is further enhanced by an independent external safety and ethics committee that monitors all results,” noted Khoo.
The developers are actively encouraging pharma companies, biotechs, and academic institutions to put forward possible Covid-19 treatment candidates for consideration. The candidates will have to meet the stipulations of a UK national prioritization process before they will be accepted for a trial.
US-based biotech company Ridgeback Biotherapeutics, which focuses on developing treatments for orphan and infectious diseases, will be the first to test a drug candidate in Covid-19 patients using AGILE. The treatment consists of an oral antiviral drug that has shown promise against Covid-19 in preclinical testing.
The team behind the platform say that it is adaptable for use in different countries and that it could also be used in future epidemic or pandemic scenarios. However, it may not be suitable for drug development for non-infectious diseases.
“AGILE is focused on pandemic settings where treatment courses are shorter, and treatments with a rapid and sizable impact are sought,” said Khoo. “Treatments with a smaller magnitude of effect over a longer period, for example, chronic diseases, may be less suitable for assessment in AGILE.”