Mitsubishi Tanabe initiates Phase III BouNDless study of ND 0612 to treat Parkinson's disease.

Mitsubishi Tanabe Pharma America announced the initiation of the Phase III BouNDless study investigating the efficacy, safety and tolerability of ND 0612, a potential non-surgical, subcutaneous continuous treatment, compared to oral immediate-release carbidopa/levodopa (CD/LD) in people with Parkinson's disease (PD) experiencing motor fluctuations.

Clinical development of ND 0612 is being led by NeuroDerm. If regulatory approval is obtained, MTPA intends to commercialize the therapy in the U.S. Both MTPA and NeuroDerm are wholly owned subsidiaries of Mitsubishi Tanabe Pharma Corporation (MTPC). The multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial will enroll a total of approximately 300 people with PD experiencing motor fluctuations, whose symptoms are no longer controlled by conventional treatments (average of at least 2.5 hours motor fluctuations daily, with a minimum of 2 hours every day in the "OFF" state during waking hours), at approximately 120 sites globally. The primary objective of the study is to determine the effect of ND 0612 on daily "GOOD ON" time (defined as the sum of "ON" time without dyskinesia and "ON" time with non-troublesome dyskinesia), as measured by a self-reported patient diary assessing motor function. The BouNDless study design will be presented at the International Congress of Parkinson's Disease and Movement Disorders in Nice, France, being held September 22-26, 2019.