NeuroDerm, Ltd. announced today that enrollment of patients is ongoing in its Phase IIa clinical trial of ND0612, a novel drug formulation for the treatment of Parkinson's disease. ND0612 is a proprietary levodopa/carbidopa liquid formula under development for continuous sub-cutaneous administration through a patch pump. It is designed to provide steady levodopa blood levels in Parkinson's disease.
In previous phase I studies, ND0612 was shown to be safe and tolerable and reached steady state, clinically meaningful levodopa concentrations for the first time in man. Furthermore, steady state levodopa concentrations were maintained in a practical manner during both day and night. The current Phase II double-blind, randomized placebo controlled study in Parkinson's disease patients will assess ND0612 for safety and tolerability as well as for levodopa and carbidopa steady state plasma levels.
"Following its success in phase I trials, ND0612 is now entering trials in patients. An important objective of this study will be to find out what steady state levodopa concentrations can be reached in patients. In healthy volunteers, ND0612 reached day and night steady state levodopa levels, the elusive holy grail of Parkinson's levodopa therapy, in a conveniently administered drug that should be available to all PD patients. Moreover, ND0612 bypasses the gastrointestinal tract and should be little influenced by intestinal absorption or oral ingestion of food or drugs. This trial marks a landmark in the development of ND0612, a novel levodopa drug that could become a breakthrough treatment option in Parkinson's Diseases."