Digital biomarker to enhance precision, reduce patient burden and boost efficiency of global Phase 2 trial of NEU-411 in early Parkinson’s disease
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--#LRRK2--Neuron23® Inc., a clinical-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases, today announced a collaboration with Roche to incorporate a digital biomarker developed by Roche Information Solutions (RIS), the Roche group focused on digital health solutions, as the primary endpoint in the global Phase 2 NEULARK clinical trial of NEU-411, a brain-penetrant, potent and selective inhibitor of LRRK2, in early-stage Parkinson’s disease (PD).
Clinical development in PD has historically been challenged by symptom variability that reduces the sensitivity and reliability of clinical outcome assessments. The navify® digital biomarker solution has been designed to frequently measure PD symptoms, such as slowed movement and tremor, as well as non-motor symptoms such as cognition. Potential benefits of using this smartphone-based solution include significantly greater frequency of data measurement as compared to clinical rating scales, which are typically assessed every 8-12 weeks, as well as more objective and precise quantification of symptoms. Built on extensive clinical and observational data in PD patients, the navify digital biomarker solution provides valuable insights into disease progression.
“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. Financial terms of the agreement were not disclosed.
About Parkinson’s disease
Parkinson’s disease (PD) is a brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness and difficulty with balance and coordination. Symptoms usually begin gradually and worsen over time. As the disease progresses, people may have difficulty walking and talking. Additional symptoms can include mental and behavioral changes, such as sleep problems, depression, memory difficulties and fatigue.
Some cases of PD appear to be hereditary, and a few cases can be traced to specific genetic mutations. Currently, there is no cure or therapy that impacts underlying disease progression available for PD, and treatment options are only used to alleviate some symptoms.
About LRRK2
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.
About NEU-411
NEU-411 is a brain-penetrant, potent and 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. In a Phase 1 clinical trial, NEU-411 was safe and well tolerated in over 100 healthy volunteers for up to 28 days. NEU-411 also demonstrated robust target engagement of the LRRK2 pathway using fluid-based biomarkers that can be detected in healthy individuals, demonstrating NEU-411’s ability to inhibit LRRK2. Extensive pharmacodynamic, pharmacokinetic and chronic safety studies in animals have provided a strong foundation for NEU-411’s clinical development.
About Neuron23®
Neuron23® Inc. is a clinical-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases. Neuron23 combines recent advances in human genetics with a state-of-the-art drug discovery and biomarker platform using advanced techniques in machine learning and artificial intelligence to advance therapeutics for devastating diseases. The Company’s focus areas are neurodegenerative diseases, neuroinflammatory diseases, and systemic autoimmune and inflammatory diseases. Founded in 2018, Neuron23 has assembled a world-class team of experts and entrepreneurs located in South San Francisco, CA. For more information, please visit www.neuron23.com.
Contacts
Ashlea Kosikowski
1AB
ashlea@1abmedia.com
