BERGEN, Norway, June 2, 2020 /PRNewswire/ -- BerGenBio ASA
(OSE:BGBIO), a clinical-stage biopharmaceutical company developing
novel, selective AXL kinase inhibitors for severe unmet medical
need, today announces that dosing has commenced in the UK
Government-backed Phase II clinical trial assessing bemcentinib in
hospitalised 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.
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 hospitalised 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.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "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."
Professor Tom Wilkinson,
ACCORD clinical academic lead based at the National
Institute for Health Research (NIHR) Southampton
Biomedical Research Centre, said: "The ACCORD platform
is allowing us to rapidly test potential new treatments in response
to the COVID-19 emergency. This unique national platform for
developing COVID-19 drug candidates will access the world-class
expertise and resources of the NIHR Respiratory Translational
Research Collaboration and allied centres nationwide. We believe
this programme will be key to developing effective new treatments
and are delighted to see the first candidate, bemcentinib, enter
the clinic today."
About BerGenBio
BerGenBio is a clinical-stage biopharmaceutical company focused
on developing transformative drugs targeting AXL as a potential
cornerstone of therapy for aggressive diseases, including
immune-evasive, therapy resistant cancers and COVID-19 infections.
The company's proprietary lead candidate, bemcentinib, is a
potentially first-in-class selective AXL inhibitor in a broad Phase
II oncology clinical development programme focused on combination
and single agent therapy in lung cancer, leukaemia and COVID-19. A
first-in-class functional blocking anti-AXL antibody, tilvestamab,
is undergoing Phase I clinical testing. In parallel, BerGenBio is
developing companion diagnostic tests to identify those patient
populations most likely to benefit from bemcentinib or tilvestamab:
this is expected to facilitate more efficient registration trials
and support a precision medicine-based commercialisation
strategy.
BerGenBio is based in Bergen, Norway with a subsidiary
in Oxford, UK. The company is listed on the Oslo Stock
Exchange (ticker: BGBIO). For more information,
visit www.bergenbio.com
For more information, please contact
Richard Godfrey CEO, BerGenBio ASA
+47-917-86-304
Rune Skeie, CFO, BerGenBio
ASA
rune.skeie@bergenbio.com
+47-917-86-513
International Media Relations
Mary-Jane Elliott,
Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44-7780-600290
Media Relations in Norway
Jan
Petter Stiff, Crux Advisers
stiff@crux.no
+47-995-13-891
Forward looking statements
This announcement may contain forward-looking statements,
which as such are not historical facts, but are based upon various
assumptions, many of which are based, in turn, upon further
assumptions. These assumptions are inherently subject to
significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and
other important factors could cause actual events to differ
materially from the expectations expressed or implied in this
announcement by such forward-looking statements.
This information is subject to the disclosure requirements
pursuant to section 5-12 of the Norwegian Securities Trading
Act.
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