Centogene N.V. announced that it has extended the Rostock International Parkinson's Disease 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 articipation 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.

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. Following 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. 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.