Positive Phase 3 ND0612 Trial Results for Parkinson's Motor Fluctuations

A significant breakthrough in Parkinson's disease treatment has been reported by Mitsubishi Tanabe Pharma Corporation (MTPA), with the successful Phase 3 BouNDless trial results published in The Lancet Neurology. The trial focused on ND0612, a novel subcutaneous infusion therapy for patients experiencing motor fluctuations. The study showed that ND0612 was more effective than oral levodopa/carbidopa at increasing "ON" time without dyskinesia and reducing "OFF" time, after a 12-week period.

Professor Alberto Espay, the lead U.S. investigator for the trial, highlighted the importance of oral levodopa/carbidopa as the primary treatment for Parkinson's disease, but also noted its diminishing efficacy over time. The positive results from the trial offer hope for patients with limited options due to motor fluctuations.

Participants in the study underwent an initial phase with oral immediate-release levodopa/carbidopa, followed by a phase with ND0612 infusion in addition to oral medication. They were then randomly assigned to either continue with ND0612 or switch to oral levodopa/carbidopa for 12 weeks in a double-blind setting. The primary endpoint was significantly achieved with ND0612, adding 1.72 hours of "ON" time without troublesome dyskinesia. Additionally, ND0612 led to a 1.4-hour reduction in daily "OFF" time compared to oral medication.

The secondary endpoints also showed positive results, with improvements in the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II scores, and in the global impressions of both patients and clinicians. The safety profile of ND0612 was found to be in line with that of oral levodopa/carbidopa, although infusion site reactions were more common in the ND0612 group.

Dr. Gustavo A. Suarez Zambrano, Vice President of Medical Affairs at MTPA, emphasized the potential impact of ND0612 on the lives of those with Parkinson's disease and the company's commitment to addressing unmet needs in patient care. The ongoing BouNDless trial results are complemented by long-term safety data from the BeyoND study, which has been following some patients for up to eight years.

ND0612 is an innovative drug-device combination therapy developed by NeuroDerm, Ltd., a subsidiary of MTPC, for the continuous 24-hour subcutaneous infusion of liquid levodopa/carbidopa. The therapy is currently under review by the U.S. Food and Drug Administration (FDA), with a target action date set for the second quarter of 2024.

MTPA, based in Jersey City, New Jersey, is a subsidiary of MTPC, established to advance the pharmaceutical pipeline and commercialize products in North America. MTPC, founded in 1678 and part of the Mitsubishi Chemical Group, is dedicated to creating hope for those facing illness, focusing on areas such as the central nervous system, immuno-inflammation, diabetes, kidney disease, and cancer. The company is committed to precision medicine and developing comprehensive solutions for patient care.

NeuroDerm, Ltd., based in Israel, is another subsidiary of MTPC, focused on improving the quality of life for patients through innovative therapies and technologies, particularly for central nervous system disorders.