Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Bioteknik |
2021-03-04 07:00:15
Bergen, Norway, 4[th] March 2021?- 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."
-Ends-
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.