Centogene N.V. (Nasdaq: CNTG), the commercial-stage essential
biodata life science partner for rare and neurodegenerative
diseases, today announced reaching a significant milestone with the
recruitment and genetic testing of 12,500 participants in the
Rostock International Parkinson's Disease (ROPAD) Study. With more
than 120 study sites around the world, CENTOGENE is leading the
largest study of its kind – a global observational study focused on
the role of genetics in Parkinson's disease (PD). As part of the
ROPAD study, CENTOGENE utilizes CentoCard®, its proprietary,
CE-marked dried blood spot collection kit in combination with
state-of-the-art sequencing technologies to develop a
first-in-class Parkinson’s Disease Panel that is being used to
screen participants for mutations in leucine-rich repeat kinase 2
(LRRK2) as well as other PD-associated genes. CENTOGENE’s
Parkinson’s Disease Panel has been widely adopted by clinicians,
and its use could provide vital information to allow more precise
therapeutic development in the future.
Having met the initial milestone of recruiting
and performing genetic testing of 10,000 participants in March
2021, CENTOGENE and Denali Therapeutics extended their partnership
to recruit and test an additional 2,500 patients. In 2018,
CENTOGENE entered a strategic collaboration with Denali
Therapeutics for the targeted global identification of PD patients
with mutations 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 a LRRK2 mutation
may be eligible for participation in future therapeutic clinical
studies. CENTOGENE conducts clinical studies with biopharma
partners around the world, such as Denali Therapeutics, who are
currently evaluating the efficacy and safety of a small molecule,
LRRK2 inhibitor, which aims to slow the progression of PD in
individuals with a pathogenic mutation in LRRK2 in the LIGHTHOUSE
study. More information about LIGHTHOUSE (NCT05418673) is available
at ClinicalTrials.gov.
“Parkinson’s disease is a devastating
neurodegenerative disease, and there is a significant medical need
to truly unveil deeper data on PD genetics to accelerate diagnosis
and personalized Parkinson’s treatments,” said Kim Stratton, Chief
Executive Officer at CENTOGENE. “In reaching such a pivotal
milestone in our Parkinson’s disease study, we have been able to
unlock significant insights into the genetic factors – which we
believe together with partners, such as Denali with their
therapeutics targeting LRRK2, will accelerate the development of
potentially life-saving therapeutics for many PD patients around
the world.”
“More than 10 million people worldwide are
affected by Parkinson’s disease, many of which are tied to genetic
factors, like LRRK2,” said Carole Ho, M.D., Chief Medical Officer
at Denali. “In combining forces with CENTOGENE, we have unlocked
significant insights and are committed to working together towards
a unified goal of accelerating the development of potentially
life-saving therapeutics for PD patients around the world.”
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 (PD). 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 collection kit in
combination with state-of-the-art sequencing technologies to screen
for mutations in LRRK2 and other PD-associated genes. This is based
on insights powered by the CENTOGENE Biodatabank, what the Company
believes to be the world’s largest real-world data repository for
rare and neurodegenerative diseases. Throughout this study, 12,500
participants from around the world have been tested over a circa
three-year period.
Patients with mutations in PD 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 is being performed. Patients enrolled in ROPAD and
identified with a LRRK2 mutation may be eligible for participation
in future therapeutic clinical studies. CENTOGENE conducts clinical
studies with biopharma partners around the world, such as Denali
Therapeutics, who are currently developing a small molecule, LRRK2
inhibitor for the treatment of PD.
To learn more about ROPAD, visit:
https://www.centogene.com/pharma/clinical-trial-support/rostock-international-parkinsons-disease-study-ropad
About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical
company developing a broad portfolio of product candidates
engineered to cross the blood-brain barrier (BBB) for
neurodegenerative diseases. 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 (Nasdaq: CNTG) is transforming
real-world clinical, genetic, and multiomic data to enable better
health outcomes for patients with rare and neurodegenerative
diseases. For over 15 years, CENTOGENE has been providing
diagnostic insights to patients with genetic diseases through our
network of nearly 30,000 active physicians. CENTOGENE now believes
its Biodatabank is the world’s largest real-world data repository
of corresponding patients from more than 120 countries. Simplified
logistics solutions, including CentoCard® for sending biosamples,
and our ISO, CAP, & CLIA certified state-of-the-art multiomic
reference labs offer patients rapid and reliable diagnoses to
support the identification and personalization of their treatments.
Ultimately, offering the best treatment for patients involves
developing new or better therapies. We are de-risking orphan drug
discovery and development by partnering with more than 30 biopharma
in target & drug screening, clinical development, market access
and expansion. CENTOGENE engages in biodata partnerships with our
Biodata Licenses and Insight Reports.
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 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 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.
Media Contact:
CENTOGENEBen LeggCorporate
CommunicationsPress@centogene.com
Lennart StreibelInvestor
RelationsInvestor.Relations@centogene.com
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