BerGenBio has announced that bemcentinib has been selected as the first potential treatment to be fast-tracked in a new UK national multi-centre randomized 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). ACCORD brings together a single, UK-wide clinical trial platform provided by the clinical research company IQVIA and UK 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 randomized controlled clinical trial for COVID-19 treatment.
“We are delighted to be part of this initiative which is a ground-breaking partnership between government, academia and industry. We are hopeful that bemcentinib can play a significant role in the global effort to find suitable treatment options for COVID-19 patients, 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. We are poised to commence dosing in the coming days and will provide results as soon as is practically possible,” says Richard Godfrey, Chief Executive Officer of BerGenBio.
Data will readout within a few months
The ACCORD study is a multicentre Phase II adaptive randomization platform trial to assess the efficacy and safety of multiple candidate agents, the first of which is bemcentinib, for the treatment of COVID-19 in hospitalised UK NHS patients. The study, with drug material and trial resources provided by BerGenBio, will rapidly commence testing in 120 subjects (60 hospitalized COVID-19 patients and 60 control group patients receiving standard of care treatment) across 6 UK NHS hospital trusts, with the first patients due to be treated imminently.
BerGenBio anticipates that top line data will readout within a few months. Data will be open source and freely available to enable global knowledge sharing and collaboration.
If positive results are seen, bemcentinib will advance rapidly into the large-scale Phase III trials currently in progress across the UK.
Bemcentinib’s applicability to treat COVID-19
Preclinical data suggest that bemcentinib is potentially useful for the treatment of early SARS-CoV-2 infection. Bemcentinib is a once-a-day, oral, highly selective and potent inhibitor of AXL kinase. Bemcentinib has previously demonstrated a key role in cancer treatment: preventing immune evasion, drug resistance and metastasis in a variety of cancer trials.
The drug has to date been shown to be safe and well-tolerated in patients and in many cases taken daily for several years, states the company.
Bemcentinib has previously been reported to exhibit potent anti-viral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus. Recent data have expanded this to SARS-CoV-2. Bemcentinib selectively inhibits AXL kinase activity, blocking viral entry and enhancing the anti-viral type I interferon response, a key cellular defence mechanism against viral infection.
“There has been a tremendous effort to pull this initiative together so rapidly. ACCORD is a national effort and will be key to developing effective new treatments which are needed so desperately. The ACCORD platform will be able to rapidly test potential new treatments, advancing the most promising through Phase 2 clinical trials into the NHS. This unique national platform for developing new COVID-19 drug candidates will access the world-class expertise and resources of the NIHR Respiratory Translational Research Collaboration and allied centres nationwide,” says Professor Tom Wilkinson, ACCORD clinical academic lead based at the National Institute for Health Research (NIHR) Southampton Biomedical Research Centre.
ACCORD is part of a co-ordinated therapeutic development pathway that the Government has put in place, overseen by the Department for Business, Energy and Industrial Strategy and delivered by UKRI, as part of the overall Therapeutics Taskforce.
Photo of Richard Godfrey: Nils Olav Mevatne