ACCORD is a multicentre, seamless, Phase II adaptive randomisation platform trial to assess the efficacy and safety of multiple candidate agents.
BerGenBio’s AXL kinase inhibitor bemcentinib has been selected as the first potential treatment to be fast-tracked in a new UK national multicentre randomised Phase II clinical trial initiative.
The ACcelerating COVID-19 Research & Development platform (ACCORD) study is being funded by the Department of Health and Social Care (DHSC) and UK Research and Innovation (UKRI).
It brings together a single, UK-wide clinical trial platform provided by the clinical research company IQVIA and the UK’s leading research expertise through the National Institute for Health Research, to rapidly test potential drugs through early stage clinical trials and feed them into the UK’s large-scale COVID-19 studies, such as the RECOVERY trial, currently the world’s largest randomised controlled clinical trial for COVID-19 treatment.
It is hoped that the move will give an early indication of bemcentinib’s effectiveness in treating the most vulnerable patients with COVID-19.
The study, with drug material and trial resources provided by BerGenBio, will rapidly commence testing in 120 subjects (60 hospitalised COVID-19 patients and 60 control group patients receiving standard of care treatment) across six UK NHS hospital trusts, with the first patients due to be treated imminently.
BerGenBio anticipates that topline data will readout within a few months, and it is to be open source and freely available “to enable global knowledge sharing and collaboration”.
If successful, bemcentinib will then advance rapidly into the large-scale Phase III trials currently in progress across the UK.
“We are delighted to be part of this initiative which is a ground-breaking partnership between government, academia and industry,” said Richard Godfrey, BerGenBio’ chief executive. “We are hopeful that bemcentinib can play a significant role in the global effort to find suitable treatment options for COVID-19 patients”.
Health and social care secretary Matt Hancock added: “Currently no drugs in the world have been clinically proven to treat Covid-19. But our Therapeutics Taskforce has identified a number of promising candidates. Currently, six different treatments have been entered into national clinical trials and the first is ready to enter the next stage: a new early phase clinical trial platform that we are launching.
“This is a national effort made possible by government, academia and industry working together.”
29th April 2020