BERGEN, Norway, December 15, 2022 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced that the Trial Steering Committee of
the EU-SolidAct has recommended to discontinue the bemcentinib study arm in the
Ph2b EU-SolidAct platform study in hospitalized COVID-19 patients due to a lack
of eligible patients. This recommendation is supported by BerGenBio. The
regulatory sponsor of the study, Oslo University Hospital, will enact this
decision.
In April 2023, BerGenBio announced that the parties unanimously decided to pause
the bemcentinib study arm due to a lack of eligible patients. The parties also
agreed that a potential resumption of the study arm would be subject to eligible
patients being available.
BerGenBio will not incur any financial impact from the closure of the
bemcentinib study arm.
Martin Olin, BerGenBio's Chief Executive Officer stated, "The changing nature of
the COVID-19 pandemic makes further conduct of this study arm infeasible and we
agree with the Trial Steering Committee's decision. Our prior work in
hospitalized COVID-19, including two Phase 2 studies, confirms that bemcentinib
may reduce patient morbidity and mortality when severe respiratory infections
are present. This extensive dataset gives us reassurance that further work in
this area is warranted and we continue to evaluate the potential of bemcentinib
in severe respiratory infections caused by other viral pathogens, including
Respiratory Syncytial Virus (RSV) and influenza."
-End-
Contacts
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
Investor Relations / Media Relations
Jan Lilleby
jl@lillebyfrisch.no
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 cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate, bemcentinib, a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and severe respiratory infections.
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
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.