Mitsubishi Tanabe Pharma to Present Phase 3 Data on Continuous Levodopa Infusion ND0612 for Parkinson's Disease
核心洞察
Mitsubishi Tanabe Pharma America (搜索) will present four poster presentations on investigational ND0612 at the 2025 International Congress of Parkinson's Disease (搜索) and Movement Disorders.
The presentations will share findings from the pivotal Phase 3 BouNDless study evaluating ND0612 versus standard of care in Parkinson's disease (搜索) patients experiencing motor fluctuations (搜索).
ND0612 is a 24-hour continuous subcutaneous infusion of liquid levodopa/carbidopa designed to address motor fluctuations (搜索) in Parkinson's disease (搜索) patients.
Mitsubishi Tanabe Pharma America (搜索) announced four poster presentations on investigational ND0612 will be shared at the 2025 International Congress of Parkinson's Disease (搜索) and Movement Disorders, being held October 5-9 in Honolulu, Hawaii. The presentations will showcase findings from the pivotal Phase 3 BouNDless study evaluating the continuous subcutaneous infusion therapy in Parkinson's disease patients experiencing motor fluctuations (搜索).
"We look forward to hearing from leading experts in the field at the meeting and discussing new data on ND0612," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at Mitsubishi Tanabe Pharma America (搜索). "We continue to refine our understanding of the potential of ND0612 and are committed to collaborating with the greater scientific community to drive forward innovation in Parkinson's disease (搜索) research."
Phase 3 BouNDless Study Results
The presentations will share findings from the Phase 3 BouNDless study (NCT04006210), which evaluated ND0612 versus standard of care in people with Parkinson's disease (搜索) experiencing motor fluctuations (搜索). The study assessed key endpoints including ON time and OFF time, along with pharmacokinetics, efficacy across disease stages, dyskinesia (搜索) and functional outcomes.
Four specific presentations are scheduled for October 7 in Exhibit Hall 1 from 12:00-2:30 p.m. HST:
Pharmacokinetic Analysis of Subcutaneous Levodopa/Carbidopa Delivery with ND0612 will be presented by Jordan Dawson from Mitsubishi Tanabe Pharma America (搜索) at 12:12 p.m. HST.
Efficacy of ND0612 in Patients at Different Stages of Disease Severity will examine subgroup analyses from the randomized, active-controlled study, presented by Harini Sarva, M.D., FAAN from New York Presbyterian Hospital at 12:24 p.m. HST.
Dyskinesia (搜索) Outcomes with ND0612 in Parkinson's Disease (搜索) will analyze results from the randomized, active-controlled study, presented by Alberto Espay, M.D., FAAN from University of Cincinnati at 12:57 p.m. HST.
Reduced Falls with ND0612 will present supportive analyses from the BouNDless Phase 3 study, delivered by Stuart H. Isaacson, M.D., FAAN from Parkinson's Disease (搜索) & Movement Disorders Center of Boca Raton at 1:42 p.m. HST.
Investigational Therapy Design
ND0612 is an investigational drug-device combination therapy designed as a 24-hour, continuous subcutaneous infusion of liquid levodopa/carbidopa for treating motor fluctuations (搜索) in people with Parkinson's disease (搜索). Development of the investigational therapy is being led by NeuroDerm (搜索), Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation.
The continuous delivery approach represents a potential advancement in addressing motor fluctuations (搜索) that commonly affect Parkinson's disease (搜索) patients as their condition progresses. The subcutaneous infusion method aims to provide steady medication levels throughout the day, potentially reducing the on-off fluctuations that can significantly impact patient quality of life.