Regulatory Filings • Apr 25, 2022
Regulatory Filings
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BERGENBIO PRESENTS BEMCENTINIB COVID-19 CLINICAL TRIAL DATA AT ECCMID 2022
Bergen, Norway, 25 April 2022 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, announces that it is presenting data today from its Phase
IIa bemcentinib COVID-19 clinical trial (BCBC020) in a poster presentation at
the 32nd European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID), being held both online and in-person in Lisbon, Portugal, from April
23-26, 2022.
The poster presentation will share findings from the Company's Phase IIa open
label study of 115 patients evaluating bemcentinib in combination with Standard
of Care (SoC) compared to a SoC control arm in the treatment of moderate to
severe COVID-19 patients, immediatelyafter hospital admission (BGBC020).
Clinical data from the study show that bemcentinibtreatment (up to 14 days)
confers early and sustained protection, limiting clinical deterioration in
patients. Bemcentinib treated patients were discharged earlier from the
hospital, required less supplementary oxygen and demonstrated a significant
reduction in the need for intubation or ventilation.
Biomarker analysis demonstrates that treatment with bemcentinibreduced markers
of acute inflammation and profibrotic cytokines, and increased expression of
protective factors. These changes were more pronounced in patients with more
serious disease, determined by high C-Reactive Protein (CRP) rates, high
neutrophil to lymphocyte ratio (N/L) ratio or increased oxygen usage.
Preclinical data is also being presented from in vitro studies in lung
epithelial cells on bemcentinib's activity on variants of concern. These data
suggest that bemcentinib inhibits infection of multiple SARS-CoV-2 variants,
including Omicron, building on previous preclinical research from the Company.
Martin Olin, CEO of BerGenBio, commented: "The data we are presenting at ECCMID
today further demonstrates the effectiveness of bemcentinib as a treatment for
severe respiratory infections such as COVID-19. We have been pleased to see
bemcentinib's impact on reducing disease deterioration in patients. In addition,
we're encouraged to see that bemcentinib exerts a broad anti-inflammatory and
pro-repair effect on blood biomarkers. We look forward to the initiation of the
EUSolidAct platform trial which will further assess bemcentinib in hospitalised
COVID-19 patients."
Details of today's poster presentation are as follows:
Abstract: 04778: Bemcentinib modulation of inflammatory, fibrotic and tissue
repair pathways correspond with favourable clinical outcomes in hospitalised
COVID-19 patients demonstrating higher severity cues: a biomarker perspective
Session Name: 12c. Clinical features, case management, outcome (incl long-term):
programme no. L0383
Time, Location: Monday, 25th April 2022, 12:00pm - 13:00pm (WEST)
-End-
Contacts:
Martin Olin CEO, BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
Consilium Strategic Communications
+44 20 3709 5700
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 and COVID
-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is
undergoing phase I clinical testing.
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. Suchrisks, 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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