Providing patients with genetic testing designed to accelerate the diagnosis and personalized treatment of Parkinson’s disease (PD)
- The Rostock International Parkinson's Disease (ROPAD) Study aims to characterize the genetics of PD to establish a better understanding of disease progression, diagnosis, and treatment for patients
- Having recently reached a significant milestone of 10,000 participants, the study now aims to recruit and genetically test an additional 2,500 patients for Parkinson’s, one of CENTOGENE’s key prioritized diseases
- This next phase of the ROPAD Study will focus on 40 targeted sites across 11 countries – maximizing regional efforts to generate insights into the genetic factors of Parkinson’s
CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, May 10, 2021 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, announced today that it has extended the Rostock International Parkinson's Disease (ROPAD) Study. Having recently met the milestone of recruiting and performing genetic testing of 10,000 participants, the study now aims to recruit and test an additional 2,500 patients by the end of 2021 – helping to generate insights into one of CENTOGENE’s key prioritized diseases. Based on initial findings, the study will focus its efforts on 40 sites across 11 countries, including Brazil, Germany, Italy, Spain, and the U.S.
Prof. Peter Bauer, Chief Genomic Officer at CENTOGENE, said, "We recently reached a significant study milestone, but this is just the beginning. There are several steps ahead that need to be taken to get patients the solutions they need. By extending this study and recruiting additional patients, we will be able to unveil deeper data on Parkinson's disease genetics, diagnose patients earlier, and accelerate personalized Parkinson’s treatments.”
In 2018, CENTOGENE entered into a strategic collaboration with Denali Therapeutics for the targeted global identification and recruitment of Parkinson’s disease patients with mutations in the LRRK2 gene. Mutations in LRRK2 are one of the most commonly known genetic causes of Parkinson’s disease. Patients enrolled in ROPAD with an LRRK2 mutation may be eligible for participation in future therapeutic clinical studies, including with Denali Therapeutics, which is developing a small molecule LRRK2 inhibitor for the treatment of Parkinson’s disease in collaboration with Biogen.
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 collection kit in combination with state-of-the-art sequencing technologies to screen for mutations in LRRK2 and other PD-associated genes. To date, 10,000 participants from around the world have been tested over a two-year period. The study has now been extended in order to recruit and genetically test an additional 2,500 participants.
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 will be performed. Patients may be offered participation in future interventional clinical studies, including with study partner Denali Therapeutics, which is developing a small molecule LRRK2 inhibitor for the treatment of Parkinson’s disease in collaboration with Biogen.
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 CENTOGENE
CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies. Our goal is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our extensive rare disease knowledge, including epidemiological and clinical data, as well as innovative biomarkers. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository with over 3.9 billion weighted data points from approximately 600,000 patients representing over 120 different countries as of December 31, 2020.
The Company’s platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, and also a biobank of these patients’ blood samples. CENTOGENE believes this represents the only platform that comprehensively analyzes multi-level data to improve the understanding of rare hereditary diseases, which can aid in the identification of patients and improve our pharmaceutical partners’ ability to bring orphan drugs to the market. As of December 31, 2020, the Company collaborated with over 30 pharmaceutical partners.
Important Notice and Disclaimer
This press release contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions, or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of our strategies, financing plans, growth opportunities, and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project” or “expect,” “may,” “will,” “would,” “could,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the Company. However, these forward- looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties, and other variable circumstances, such as negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, 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, or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
For further information, please refer to the Risk Factors section in our Annual Report for the year ended December 31, 2020, on Form 20-F filed with the SEC on April 15, 2021, and other current reports and documents furnished to or filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov .
Media Contact: CENTOGENE Ben Legg Corporate Communications press@centogene.com FTI Consulting Bridie Lawlor O’Boyle +1.917.929.5684 bridie.lawlor@fticonsulting.com
