Israel-based pharmaceutical company NeuroDerm has started patient enrolment in its second Phase II clinical trial of ND0612, a novel drug formulation, for the treatment of Parkinson's disease (PD).
ND0612 is a proprietary levodopa/carbidopa liquid formulation being developed for continuous subcutaneous administration through a patch pump and is designed to provide steady levodopa blood levels for the treatment of PD.
The ongoing double-blind, randomised placebo controlled Phase II study will evaluate 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.
The trial is supported by a grant of $1m each from The Michael J Fox Foundation for Parkinson's Research and the Foundation to NeuroDerm's continuous SC administration dopaminergic programme.
NeuroDerm CEO Oded Lieberman said following the 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," Lieberman said.
"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."
The previous Phase I and Phase IIa trials showed that ND0612 is safe, tolerable and reached steady state, clinically meaningful levodopa concentrations.
In addition, it was showed that the levodopa concentrations could be preset to reach different day and night levels.
ND0612 continuously delivers levodopa to achieve straight-line and clinically-significant levodopa blood levels both day and night.
In addition, ND0612 also delivers subcutaneous continuous carbidopa to further improve the bioavailability of levodopa.
NeuroDerm believes ND0612 help improves the management of motor fluctuations even in patients under the best current standard of care with oral levodopa therapy.