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 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. If positive results are seen, bemcentinib will advance rapidly into the large-scale Phase III trials currently in progress across the UK.
Bemcentinib is a once-a-day, oral, highly selective and potent inhibitor of AXL kinase being developed by BerGenBio. 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 hundreds of patients and in many cases taken daily for several years.
The drug 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.
Richard Godfrey, Chief Executive Officer of BerGenBio, said: “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.”
Health and Social Care Secretary, Matt Hancock, said:“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 today. This is a national effort made possible by government, academia and industry working together.”
Professor Tom Wilkinson, ACCORD clinical academic lead based at the National Institute for Health Research (NIHR) Southampton Biomedical Research Centre, said: “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.”
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.