NeuroDerm, Ltd. announced today that enrollment of healthy subjects is ongoing in its Phase I clinical trial of ND0612, a novel drug formulation for the treatment of Parkinson's disease. ND0612 is a proprietary levodopa/carbidopa liquid formula administered continuously via a subcutaneous delivery patch device. It is designed to provide steady levodopa blood levels and enhanced bioavailability of oral levodopa for the reduction of motor complications in Parkinson's disease.
In pre-clinical studies of ND0612, plasma concentrations of levodopa reached straight-line steady state levels. The current Phase I double-blind, dose-escalation trial in young, healthy volunteers will assess ND0612 for safety and tolerability as well as for levodopa and carbidopa steady state plasma levels.
"This first trial of ND0612 in man is a significant step in the development of a new levodopa treatment standard for Parkinson's disease," said Oded S. Lieberman, PhD, NeuroDerm's Chairman and CEO. "For many years, oral levodopa has been the leading Parkinson's disease drug therapy. However, due to low and erratic oral levodopa bioavailability, advanced Parkinson's patients suffer from debilitating motor complications even under the best current standard of care. Should ND0612 achieve constant levodopa base blood levels, than low, harmful levodopa trough levels would be prevented, the efficacy of current levodopa therapy could be significantly raised and a new standard of care in our ability to treat and reduce motor complications in Parkinson's disease patients may be established."