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. 

 

 

 

 

https://news.cision.com/bergenbio-asa/r/bergenbio-announces-closure-of-eu-solidact-bemcentinib-study-arm-in-hospitalized-covid-19-patients,c3894718

(c) 2023 Cision. All rights reserved., source Press Releases - English