Centogene N.V. (Nasdaq: CNTG), the essential life science partner
for data-driven answers in rare and neurodegenerative diseases,
today announced that it has extended the Rostock International
Parkinson's Disease (ROPAD) Study to recruit and genetically test
additional patients over the next few years. Based on initial
findings of the more than 12,500 participants already recruited and
genetically tested, the study will now focus its efforts on 48
sites across 10 countries, consisting of Argentina, Belgium,
Brazil, Germany, Israel, Italy, Portugal, Spain, the U.K., and the
U.S.
In 2018, CENTOGENE entered a strategic
collaboration with Denali Therapeutics for the targeted global
identification of PD patients with genetic variations in the LRRK2
gene. The LRRK2 gene is one of the most common mutated genes in
familial PD.
Patients enrolled in ROPAD and identified
with LRRK2 genetic variations may be eligible for
participation in ongoing interventional clinical studies. CENTOGENE
conducts clinical studies with pharma partners around the world,
such as Denali Therapeutics. Denali, in collaboration with Biogen
Inc., is currently evaluating the efficacy and safety of BIIB122
(DNL151), a small molecule, LRRK2 inhibitor, that aims to
slow the progression of PD in individuals with pathogenic genetic
variations in LRRK2 in the LIGHTHOUSE study. More
information about LIGHTHOUSE (NCT05418673) is available
at ClinicalTrials.gov.
“Parkinson’s disease is a devastating
neurodegenerative disease – affecting over 10 million people
worldwide from all walks of life. There is an urgent medical need
to unveil multidimensional data,” said Kim Stratton, Chief
Executive Officer at CENTOGENE. “At CENTOGENE, we find it truly
essential to establish a more inclusive and comprehensive approach
from diagnostics to drug discovery, development, and
commercialization. By extending this study alongside Denali, we are
generating multi-ethnic insights into the genetic causes –
accelerating potentially disease-modifying therapeutics for PD
patients around the world.”
“Denali is the first company to conduct clinical
trials with oral, small molecule LRRK2 inhibitors for the treatment
of Parkinson’s disease. This partnership with CENTOGENE has played
a key role in our global efforts to identify PD patients with
genetic variations in the LRRK2 gene,” said Carole Ho, M.D., Chief
Medical Officer and Head of Development at Denali. “We are
committed to working together in collaboration with Biogen to
accelerate the development of a therapy to potentially slow or stop
the progression of PD, a disease affecting several million patients
worldwide.”
About ROPAD
The Rostock International Parkinson's Disease Study (ROPAD) is a
global epidemiological study focusing on the role of genetics in
Parkinson's disease. The major goal of the study is to characterize
the genetics of PD to establish a better understanding of the
disease etiology, diagnosis, and severity.CENTOGENE utilizes
CentoCard®, the Company’s proprietary, CE-marked Dried Blood Spot
(DBS) collection kit in combination with state-of-the-art
sequencing technologies to screen for mutations
in LRRK2 and other PD-associated genes. To date, over
12,500 participants from around the world have been tested over a
three-year period. The study has now been extended in order to
recruit and genetically test additional participants.Patients with
genetic variations in PD-associated genes are offered further
clinical assessment in a supplementary study, ‘Lübeck International
Parkinson’s Disease Project (LIPAD),’ conducted at the University
of Lübeck, where a detailed phenotyping of participants will be
performed. Patients may be eligible for participation in ongoing
interventional clinical studies, including with study partner
Denali Therapeutics and Biogen Inc., which are developing a small
molecule LRRK2 inhibitor for the treatment of Parkinson’s disease
in collaboration with Biogen Inc.The ROPAD Study protocol and
initial findings were published in December 2020 in the
journal Movement Disorders, the official Journal of the
International Parkinson and Movement Disorder
Society: https://pubmed.ncbi.nlm.nih.gov/33314351/
About LRRK2 and BIIB122Following discovery of
the LRRK2 mutation as a pathogenic genetic factor for Parkinson’s
disease, further research has uncovered that it has the potential
to be a novel therapeutic target for Parkinson’s disease. Mutations
in leucine-rich repeat kinase 2 (LRRK2) account for 4-5% of
familial and 1-2% of sporadic Parkinson’s disease.
BIIB122 is a selective, central nervous system-penetrant small
molecule inhibitor of LRRK2 that is hypothesized to improve
lysosomal dysfunction, which was discovered and initially developed
by Denali. Denali and Biogen are co-developing and
co-commercializing BIIB122 for the potential treatment of
Parkinson’s disease. BIIB122 is an investigational drug that is not
approved by any regulatory authority, and its safety and efficacy
have not been established.
About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company developing a
broad portfolio of product candidates engineered to cross the BBB
for neurodegenerative diseases and lysosomal storage disorders.
Denali pursues new treatments by rigorously assessing genetically
validated targets, engineering delivery across the BBB and guiding
development through biomarkers that demonstrate target and pathway
engagement. Denali is based in South San Francisco. For additional
information, please visit www.denalitherapeutics.com.
About CENTOGENE
CENTOGENE’s mission is to provide data-driven, life-changing
answers to patients, physicians, and pharma companies for rare and
neurodegenerative diseases. We integrate multiomic technologies
with the CENTOGENE Biodatabank – providing dimensional analysis to
guide the next generation of precision medicine. Our unique
approach enables rapid and reliable diagnosis for patients,
supports a more precise physician understanding of disease states,
and accelerates and de-risks targeted pharma drug discovery,
development, and commercialization.
Since our founding in 2006, CENTOGENE has been offering rapid
and reliable diagnosis – building a network of approximately 30,000
active physicians. Our ISO, CAP, and CLIA certified multiomic
reference laboratories in Germany utilize Phenomic, Genomic,
Transcriptomic, Epigenomic, Proteomic, and Metabolomic datasets.
This data is captured in our CENTOGENE Biodatabank, with nearly
700,000 patients represented from over 120 highly diverse
countries, over 70% of whom are of non-European descent. To date,
the CENTOGENE Biodatabank has contributed to generating novel
insights for more than 260 peer-reviewed publications.
By translating our data and expertise into tangible insights, we
have supported over 50 collaborations with pharma partners.
Together, we accelerate and de-risk drug discovery, development,
and commercialization in target & drug screening, clinical
development, market access and expansion, as well as offering
CENTOGENE Biodatabank Licenses and Insight Reports to enable a
world healed of all rare and neurodegenerative diseases.
To discover more about our products, pipeline, and
patient-driven purpose, visit www.centogene.com and follow us on
LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the U.S. federal securities laws. Statements
contained herein that are not clearly historical in nature are
forward-looking, and the words “anticipate,” “believe,”
“continues,” “expect,” “estimate,” “intend,” “project,” and similar
expressions and future or conditional verbs such as “will,”
“would,” “should,” “could,” “might,” “can,” and “may,” are
generally intended to identify forward-looking statements. Such
forward-looking statements involve known and unknown risks,
uncertainties, and other important factors that may cause
CENTOGENE’s actual results, performance, or achievements to be
materially different from any future results, performance, or
achievements expressed or implied by the forward- looking
statements. Such risks and uncertainties include, among others,
negative economic and geopolitical conditions and instability and
volatility in the worldwide financial markets, possible changes in
current and proposed legislation, regulations and governmental
policies, pressures from increasing competition and consolidation
in our industry, the expense and uncertainty of regulatory
approval, including from the U.S. Food and Drug Administration, our
reliance on third parties and collaboration partners, including our
ability to manage growth, execute our business strategy and enter
into new client relationships, our dependency on the rare disease
industry, our ability to manage international expansion, our
reliance on key personnel, our reliance on intellectual property
protection, fluctuations of our operating results due to the effect
of exchange rates, our ability to streamline cash usage, our
continued ongoing compliance with covenants linked to financial
instruments, our requirement for additional financing, or other
factors. For further information on the risks and uncertainties
that could cause actual results to differ from those expressed in
these forward-looking statements, as well as risks relating to
CENTOGENE’s business in general, see CENTOGENE’s risk factors set
forth in CENTOGENE’s Form 20-F filed on March 31, 2022, with the
Securities and Exchange Commission (the “SEC”) and subsequent
filings with the SEC. Any forward-looking statements contained in
this press release speak only as of the date hereof, and
CENTOGENE’s specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events, or otherwise.
Contact:
CENTOGENE
Ben Legg Corporate
Communications Press@centogene.com
Lennart StreibelInvestor RelationsIR@centogene.com
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