BerGenBio has announced that dosing has commenced in the Phase II clinical trial assessing bemcentinib in hospitalized COVID-19 patients.
Bemcentinib was selected as the first candidate to be tested as part of the ACcelerating COVID-19 Research & Development platform (ACCORD) study, launched by the Department of Health and Social Care (DHSC) and UK Research and Innovation (UKRI) on 28th April 2020. ACCORD brings together a single, UK-wide clinical trial platform to rapidly test potential drugs through early stage clinical trials and feed them into the UK’s large-scale COVID-19 studies.
“This illustrates exactly what can be achieved when we all work together and focus on delivering the best experimental drug candidates to patients that so urgently need them.”
“We are delighted that dosing has commenced with bemcentinib in the ground-breaking ACCORD study and we hope that patients will swiftly start to see benefits. Initiating this clinical trial in such short order is the result of tremendous teamwork between my colleagues at BerGenBio and the teams at IQVIA and UHS, among many others. This illustrates exactly what can be achieved when we all work together and focus on delivering the best experimental drug candidates to patients that so urgently need them. We look forward to providing results as soon as is practically possible and very much hope our drug can fulfil the aims of the study and be used to treat thousands of COVID-19 patients worldwide,” says Richard Godfrey, Chief Executive Officer of BerGenBio.
120 subjects in total
The first patient has been dosed with bemcentinib at the University Hospital Southampton NHS Foundation Trust. The study is open in a further seven sites across the UK. The Phase II study will recruit 120 subjects in total, assessing the safety and efficacy of bemcentinib as an add‑on therapy to standard of care (SoC) in 60 hospitalized COVID-19 patients with a further 60 control group patients receiving SoC.
BerGenBio anticipates that top line data will readout later in the summer. 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 in the UK.
The study is fully funded by the DHSC and UKRI and is being managed by clinical research company IQVIA. Drug material and other trial resources will be provided by BerGenBio.
Photo: Nils Olav Mevatne – www.mevatne.no