OpGen Subsidiary Curetis and BioVersys Sign Collaboration Agreement for Clinical Trial Support
October 25 2022 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision
medicine company harnessing the power of molecular diagnostics and
bioinformatics to help combat infectious disease, and BioVersys AG,
a privately-held clinical stage, multi-asset Swiss pharmaceutical
company focusing on research and development of small molecules for
multidrug-resistant bacterial infections with applications in
antimicrobial resistance (AMR) and targeted microbiome modulation,
today announced the signing of a collaboration agreement for the
deployment and use of the Unyvero platform in BioVersys’ upcoming
Phase II clinical trial of novel drug candidate BV100.
BV100 is a much-needed injectable formulation of
rifabutin to treat serious infections caused by Carbapenem
Resistant Acinetobacter baumannii (CRAB) in patients with
ventilator-associated bacterial pneumonia (VABP), hospital-acquired
bacterial pneumonia (HABP) and bloodstream infections (BSI). Today,
mortality is typically around 50% in these patients and there are
little to no effective and safe treatment options.
In the planned Phase II clinical trial, hospital
sites will be using the Unyvero HPN for hospitalized pneumonia
patients as a rapid diagnostic test to help optimize enrollment.
Unyvero HPN allows the detection of not only Acinetobacter
baumannii but a broad array of many pathogens as well as AMR
markers that provides the broadest set of carbapenemase resistance
markers available in an integrated pneumonia cartridge.
To ensure smooth and seamless operations, the
Curetis team will train a team of trainers at BioVersys and their
clinical research organization (CRO) for the Phase II trial.
BioVersys will rent the Unyvero systems for the duration of the
trial and will purchase the pneumonia cartridges and all
consumables for the rapid diagnostics from Curetis. All data
pertaining to the clinical trial will be owned by BioVersys and can
be used in their future clinical development and regulatory
submissions as needed.
Dr. Marc Gitzinger, Chief Executive Officer and
founder of BioVersys commented: “Rapid diagnostics such as the
Curetis Unyvero platform are increasingly becoming integral to
clinical trials operational excellence in AMR, along with the
urgent need to develop novel patient orientated solutions for the
most difficult to treat infections. BioVersys is pleased to partner
with Curetis, as we rapidly develop BV100 to address the
unacceptably high CRAB mortality rate due to the lack of safe and
efficacious treatment options for these patients.”
Oliver Schacht, PhD, Chief Executive Officer of
OpGen Inc. added: “The entire OpGen and Curetis team is excited to
begin our collaboration with BioVersys and support their Phase II
clinical trial of BV100 with our Unyvero platform. With Unyvero
being the first to market CE IVD marked and FDA cleared sample to
answer platform to offer a comprehensive and uniquely
differentiated pneumonia panel and the broadest panel of AMR
markers, we believe that there will be significant value added to
patient selection and enrollment into the trial. It adds to the
growing body of clinical evidence demonstrating the benefits of
rapid pneumonia testing in hospitalized patients, also for
pharmaceutical and biotech companies and their clinical
trials.”
About BioVersys
BioVersys AG is a privately owned clinical stage
Swiss pharmaceutical company focusing on research and development
of small molecules acting on novel bacterial targets with
applications in antimicrobial resistance (AMR) and targeted
microbiome modulation. With the company’s award-winning TRIC
technology we can overcome resistance mechanisms, block virulence
production and directly affect the pathogenesis of harmful bacteria
towards the identification of new treatment options in the
antimicrobial and microbiome fields. By this means, BioVersys
addresses the high unmet medical need for new treatments against
life-threatening resistant bacterial infections and
bacteria-exacerbated chronic inflammatory microbiome disorders. Our
most advanced research and development programs address nosocomial
infections of Acinetobacter baumannii (BV100, Phase
II-ready), and tuberculosis (BVL-GSK098, Phase II-ready) in
collaboration with GlaxoSmithKline (GSK) and a consortium of the
University of Lille. BioVersys is located in the Technologiepark in
the biotech hub of Basel.
For more information, please visit www.bioversys.com.
About OpGen, Inc. OpGen, Inc.
(Rockville, MD, U.S.A.) is a precision medicine company harnessing
the power of molecular diagnostics and bioinformatics to help
combat infectious disease. Along with our subsidiaries, Curetis
GmbH and Ares Genetics GmbH, we are developing and commercializing
molecular microbiology solutions helping to guide clinicians with
more rapid and actionable information about life threatening
infections to improve patient outcomes, and decrease the spread of
infections caused by multidrug-resistant microorganisms, or MDROs.
OpGen’s current product portfolio includes Unyvero, Acuitas AMR
Gene Panel, and the ARES Technology Platform including ARESdb, NGS
technology and AI-powered bioinformatics solutions for antibiotic
response prediction including ARESiss, ARESid, and AREScloud, as
well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test
kit.
For more information, please visit www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
the collaboration agreement entered into by OpGen’s subsidiary
Curetis GmbH and BioVersys AG for their BV100 phase II clinical
trial. These statements and other statements regarding OpGen’s
future plans and goals constitute "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and are intended
to qualify for the safe harbor from liability established by the
Private Securities Litigation Reform Act of 1995. Such statements
are subject to risks and uncertainties that are often difficult to
predict, are beyond our control, and which may cause results to
differ materially from expectations. Factors that could cause our
results to differ materially from those described include, but are
not limited to, the success of our commercialization efforts, our
ability to successfully, timely and cost-effectively develop, seek
and obtain regulatory clearance for and commercialize our product
and services offerings, the rate of adoption of our products and
services by hospitals and other healthcare providers, the fact that
we may not effectively use proceeds from recent financings, the
continued realization of expected benefits of our business
combination transaction with Curetis GmbH, the continued impact of
COVID-19 on the Company’s operations, financial results, and
commercialization efforts as well as on capital markets and general
economic conditions, our ability to satisfy debt obligations under
our loan with the European Investment Bank, the effect of the
military action in Russia and Ukraine on our distributors,
collaborators and service providers, our liquidity and working
capital requirements, the effect on our business of existing and
new regulatory requirements, and other economic and competitive
factors. For a discussion of the most significant risks and
uncertainties associated with OpGen's business, please review our
filings with the Securities and Exchange Commission. You are
cautioned not to place undue reliance on these forward-looking
statements, which are based on our expectations as of the date of
this press release and speak only as of the date of this press
release. We undertake no obligation to publicly update or revise
any forward-looking statement, whether as a result of new
information, future events or otherwise.
OpGen:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Alyssa
FactorEdison Groupafactor@edisongroup.com
BioVersys contactsEliane
SchmidtExecutive Assistant to CEOTel. +41 61 633 22
50info@bioversys.com
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