UK’s new COVID-19 trial initiative fast-tracks BerGenBio’s bemcentinib

Norwegian biopharma company BerGenBio’s AXL kinase inhibitor bemcentinib has been selected as the first candidate to be tested in a new initiative organised by the UK government, aimed at fast-tracking promising products targeting COVID-19.

TheAccelerating COVID-19 Research & Development platform (ACCORD) study initiative aims to fast-track potential treatments in a national multi-centre, randomised phase 2 clinical trial. The ACCORD study will be funded by the Department of Health and Social Care (DHSC) and UK Research and Innovation (UKRI).

The clinical trial platform for the ACCORD study will be provided by clinical research company IQVIA, with the National Institute of Health Research also providing research expertise. The aim is to accelerate testing of a number of potential drugs through early-stage clinical trials, with those showing promise then advancing into other large-scale studies, such as the RECOVERY trial.

The RECOVERY trial is testing if existing or new drugs can help patients with confirmed COVID-19 disease, with the first two therapies being tested the HIV drug lopinavir-ritonavir and low-dose corticosteroids.

Now that bemcentinib has been selected to be tested in the ACCORD study, BerGenBio will rapidly commence testing in 120 participants, including 60 hospitalised COVID-19 patients and 60 control group patients receiving standard of care treatment. The testing will take place across six UK NHS hospital trusts, with the first patients due to be given the treatment as soon as possible.

According to BerGenBio, bemcentinib has demonstrated promise in preclinical data against early infection with the SARS-CoV-2 virus, which causes COVID-19. Previously, the drug has demonstrated a key role in cancer treatment by preventing immune evasion, drug resistance and metastasis. It has also previously exhibited anti-viral activity in preclinical models against other viruses, including Ebola and Zika virus.

“We are hopeful that bemcentinib can play a significant role in the global effort to find suitable treatment options for COVID-19, which has had such serious implications for so many people, and thereby ease pressures on hospital intensive care units and ultimately treat thousands of patients,” said Richard Godfrey, chief executive officer of BerGenBio.

“We are poised to commence dosing in the coming days and will provide results as soon as is practically possible,” he added.

Thanks to the rapid nature of the ACCORD study initiative, BerGenBio anticipates top-line data from the trial to be available within a few months. The results will be freely available, to ensure global collaboration and knowledge sharing.

According to the UK government, further potential treatments will be rapidly selected for the ACCORD study as the programme rolls out over the coming weeks. Initially six potential drugs, including bemcentinib, are set to enter into the study programme.