Mitsubishi Tanabe Pharma America (MTPA) has started the Phase III BouNDless trial to evaluate ND0612 in patients with Parkinson’s disease (PD).
The trial will evaluate the efficacy, safety and tolerability of the potential non-surgical, subcutaneous continuous treatment ND0612 compared to oral immediate-release carbidopa/levodopa (CD/LD).
MTPA president Atsushi Fujimoto said: “While oral CD/LD is the established standard for treating motor symptoms in Parkinson’s disease, many patients experience a decline in benefit as their disease advances, requiring them to take multiple doses throughout the day in an effort to control symptoms, often with unpredictable results.”
The multi-centre, randomised, double-blind clinical trial will enrol around 300 subjects with PD experiencing motor fluctuations from across 120 global sites.
The key objective of the study is to determine the safety and efficacy of ND0612 on daily ‘GOOD ON’ time, which is defined as the sum of ‘ON’ time without dyskinesia and ‘ON’ time with non-troublesome dyskinesia, as measured by a self-reporting patient diary that assesses motor function.
NeuroDerm is leading the clinical development of ND0612.
MTPA plans to commercialise the therapy in the US after receiving regulatory approval.
MTPA and NeuroDerm are the fully-owned subsidiaries of Mitsubishi Tanabe Pharma Corporation (MTPC).
NeuroDerm chief medical officer Sheila Oren said: “Given the limitations of current therapeutic options for Parkinson’s disease, we recognised the importance of developing a potential non-surgical continuous treatment that may stabilise CD/LD plasma levels and alleviate the disabling motor fluctuations that are often exacerbated with disease progression.”
In March 2014, NeuroDerm started patient enrolment in its second Phase II clinical trial of ND0612.