NeuroDerm announced that enrolment of patients is ongoing in its second phase II clinical trial of ND0612, a novel drug formulation for the treatment of Parkinson’s disease. ND0612 is a proprietary levodopa/carbidopa liquid formulation under development for continuous subcutaneous administration through a patch pump. It is designed to provide steady levodopa blood levels for the treatment of Parkinson’s disease.
According to a company release, in previous phase I and phase IIa studies, ND0612 was shown to be safe and tolerable and reached steady state, clinically meaningful levodopa concentrations. Furthermore, it was demonstrated that the levodopa concentrations could be preset to reach different day and night levels. The current Phase II double-blind, randomised placebo controlled study in Parkinson’s disease patients will assess ND0612 in 30 Parkinson’s disease patients over a period of 21 days for safety, tolerability, levodopa and carbidopa steady state plasma levels, and exploratory clinical parameters. This trial is supported by a grant of US$1 million by The Michael J Fox Foundation for Parkinson’s Research, the second US$1 million grant from the Foundation to NeuroDerm’s continuous SC administration dopaminergic programme.
“Following its success in earlier phase I and phase IIa trials, ND0612 is now entering more advanced phase II trials in patients. An important objective of this study will be to asses longer term steady state levodopa concentrations in patients and obtain a first impression of their effect on the patients” says Oded S Lieberman, NeuroDerm’s chief executive officer. “ND0612 bypasses the gastrointestinal tract, should not be influenced by intestinal absorption or oral ingestion of food or drugs, and is administered in a controlled, predetermined rate both day and night—a treatment mode that has not been available to date to Parkinson’s patients. This trial marks an important step in the development of ND0612 that could become a breakthrough treatment option for Parkinson’s disease patients.”