BERGEN, Norway, March 4, 2021 /PRNewswire/ -- BerGenBio ASA
(OSE:BGBIO), a clinical-stage biopharmaceutical company developing
novel, selective AXL kinase inhibitors for severe unmet medical
need, is pleased to announce it has closed recruitment into
the company sponsored randomised Phase II clinical trial (BGBC020),
assessing the efficacy and safety of bemcentinib for the treatment
of hospitalised COVID-19 patients in South Africa and India.
A total of 114 out of the target 120 hospitalised COVID-19
patients have been recruited across five sites in South Africa and seven sites in India. 56 patients received bemcentinib (as
monotherapy or in combination with standard of care medication) and
58 patients in a control group (receiving standard of care
treatment only). The trial protocol permits co-administration with
other medicines recommended for treatment of COVID-19, including
remdesivir and dexamethasone. The integrity and statistical power
of the data remains intact and top line clinical results are
expected to read out around the end of Q1 2021.
The primary endpoint of the trial is time to clinical
improvement of at least two points (from randomisation) on the WHO
nine-point ordinal scale, or live discharge from the hospital,
whichever comes first. Key secondary endpoints include viral load,
clinical markers of disease progression and survival rate.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "The
incidence of COVID-19 has fallen significantly in South Africa, so we have taken the decision to
close the study for recruitment in a timely fashion, this allows us
to analyse the data without loss of quality and maintain our
momentum in the development of bemcentinib as a potential treatment
for COVID-19. We aim to share initial data as soon as possible
around the end of this quarter and remain hopeful that bemcentinib
can play a role in treating COVID-19 patients and complement the
global vaccination programmes."
About AXL
AXL kinase is a cell membrane receptor and an essential mediator
of the biological mechanisms underlying life-threatening
diseases.
In COVID-19, AXL has two synergistic mechanisms of action, it
acts a co-receptor to ACE2, to which the spike protein of the
SARS-CoV-2 virus attaches and enters the host cell, and AXL
expression is upregulated that leads to suppression of the Type 1
Interferon immune response by host cells and in their environment.
Research data confirms bemcentinib inhibits SARS-CoV-2 host cell
entry and suppresses anti-viral Type I interferon response.
In cancer, increase in AXL expression has been linked to key
mechanisms of drug resistance and immune escape by tumour cells,
leading to aggressive metastatic cancers. AXL suppresses the
body's immune response to tumours and drives treatment failure
across many cancers. High AXL expression defines a very poor
prognosis subgroup in most cancers. AXL inhibitors, such as
bemcentinib, therefore, have potential high value as monotherapy
and as the cornerstone of cancer combination therapy, addressing
significant unmet medical needs and multiple high-value market
opportunities. Research has also shown that AXL mediates other
aggressive diseases including fibrosis.
About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potential
first-in-class, potent and highly selective AXL inhibitor,
currently in a broad phase II clinical development programme. It is
administered as an oral capsule and taken once per day. Ongoing
clinical trials are investigating bemcentinib in COVID-19, and
multiple solid and haematological tumours, in combination with
current and emerging therapies (including immunotherapies, targeted
therapies and chemotherapy), and as a single agent. Bemcentinib
targets and binds to the intracellular catalytic kinase domain of
AXL receptor tyrosine kinase and inhibits its activity.
About BerGenBio ASA
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. The company's
proprietary lead candidate, bemcentinib, is a potentially
first-in-class selective AXL inhibitor in a broad phase II
clinical development programme focused on combination and single
agent therapy in 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 a companion
diagnostic test to identify patient populations most likely to
benefit from AXL inhibition: this is expected to facilitate
more efficient registration trials supporting 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
Contacts
Richard Godfrey CEO, BerGenBio ASA
ir@bergenbio.com
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 20 3709 5700
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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https://news.cision.com/bergenbio-asa/r/bergenbio-closes-recruitment-into-trial-assessing-bemcentinib-in-covid-19-patients,c3299896
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