Neuron23 is incorporating Roche digital biomarkers in a global trial of NEU-411, a selective inhibitor of LRRK2, in early-stage Parkinson’s disease (PD). Neuron23 is a clinical-stage biotechnology company focused on developing precision medicines for neurological diseases.

Roche has developed a smartphone app incorporating digital biomarkers to assess Parkinson’s Disease. These digital biomarkers are various tests that gauge a user’s accuracy in tracing shapes and performing other manual dexterity tasks. The navify digital biomarker system has been designed to measure PD symptoms, such as slowed movement and tremor, as well as non-motor symptoms such as cognition.

Benefits of this smartphone-based system include greater frequency of data measurement as compared to clinical rating scales. The smartphone system can be used weekly, or more frequently, compared to every 8-12 weeks for conventional tests. It can also be more objective and precise in quantification of symptoms.

“The use of a digital biomarker as the primary endpoint in our clinical study has the potential to more precisely detect the impact of NEU-411 on Parkinson’s disease progression in patients, while simultaneously reducing the burden on study participants with fewer in-clinic visits, improving clinical trial efficiency and lowering costs,” said Sam Jackson, M.D., Chief Medical Officer of Neuron23. “Collaborating with Roche, the leader in development of digital biomarkers for Parkinson’s disease, provides Neuron23 with access to the leading digital platform developed specifically for the purpose of precisely measuring disease progression.”

“Many neurodegenerative diseases, such as Parkinson’s disease, share similar symptoms and features, making reliable diagnosis challenging,” said Moritz Hartmann, Global Head of Roche Information Solutions. “Roche’s digital biomarker, in conjunction with Neuron23’s Phase 2 clinical trial, represents an important step in the journey to diagnose and treat Parkinson’s disease.”

Under the Collaboration Agreement, Roche will provide device hardware and software, site support, and digital biomarker development expertise. Neuron23 will be responsible for all aspects of clinical trial conduct.

LRRK2 is a complex, multidomain protein found in neurons and many other cell types and tissues throughout the body. Mutations in the LRRK2 gene are among the most common genetic causes of PD, affecting approximately 2% of people with the disease. Individuals who inherit gain-of-function mutations in LRRK2 are at higher risk of developing PD later in life. Additionally, there is emerging evidence that LRRK2 activity may play a role in a subset of the larger population of people with non-familial PD, known as idiopathic PD, suggesting that therapies targeting LRRK2 could be beneficial to a broader patient population than just individuals with rare, familial LRRK2 mutations.

NEU-411 is a brain-penetrant, selective small molecule kinase inhibitor designed to target LRRK2-driven Parkinson’s disease, which is believed to affect approximately 30% of people with PD. By inhibiting the overactive LRRK2 kinase, NEU-411 aims to address the underlying cause of disease progression, offering a more targeted and potentially more effective treatment option.