NeuroDerm starts enrolling patients in second Phase II trial of ND0612 to treat PD

ND0612 is 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 company said that previous Phase I and Phase IIa trials have 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.

The current double-blind, randomized placebo controlled Phase II trial 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.

The Phase II trial is supported by a grant of $1m by The Michael J. Fox Foundation for Parkinson’s Research, the second $1m grant from the Foundation to NeuroDerm’s continuous SC administration dopaminergic program.

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."