Trial approved for COVID-19 pill
A drug testing platform in the United Kingdom is launching the second phase of human trials for an experimental antiviral treatment that could be given to COVID-19 patients in pill form.
The drug, which is called EIDD-2801, was initially developed to treat influenza, and researchers involved in the trial say the treatment "could change the future of the pandemic" if it displays efficacy against novel coronavirus infection.
The drug works in a similar way to remdesivir, an antiviral treatment that has shown early promise in combating severe symptoms in COVID-19 patients. EIDD-2801 has an advantage over remdesivir because it can be given to patients orally, instead of through an injection. This means that patients could take the drug at home, earlier in the course of infection.
The trial, which recently gained approval from the UK drug regulator, will be conducted at a clinical research unit at the Royal Liverpool University Hospital.
"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," said Siu Ping Lam, who is the director of licensing at the UK Medicines and Healthcare products Regulatory Agency.
EIDD-2801 was proven to be safe in humans following phase one human trials in the UK in April. The company that holds licensing for the drug, the United States-based Ridgeback Biotherapeutics, began pursuing trials in people after promising results in animal testing.
In animal studies, EIDD-2801 was shown to improve pulmonary function, decrease weight loss and reduce the viral load in the lungs.
The drug works by introducing a series of copying errors during viral RNA replication, essentially killing a virus by forcing a cascade of mutations. In a laboratory setting, EIDD-2801 has been shown to trigger this antiviral reaction in several members in the coronavirus family, including SARS, MERS, and SARSCoV-2, which is another name for the novel coronavirus.
EIDD-2801 is the first COVID-19 therapy set for human trialing under the recently-formed UK-based COVID-19 drug testing platform AGILE. The platform includes researchers from Liverpool, Southampton and Lancaster universities, as well as the Liverpool School of Tropical Medicine and the Southampton Clinical Trials Unit, among other partners.
Saye Khoo, who is a professor in molecular and clinical pharmacology at Liverpool University and is chief investigator on AGILE, said he is optimistic that the platform "will accelerate the development of treatments for COVID-19". Khoo said AGILE will bridge the gap between preclinical drug discovery and large-scale testing, thereby "rapidly identifying drugs that have the best chance of success".
"In the ongoing COVID-19 pandemic, we need to find innovative ways to identify safe and effective treatments as soon as possible," Khoo said. "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."
Last month AGILE received 2.2 million pounds ($2.76 million) in funding from Unitaid, a multinational health organization headquartered in Switzerland.
