NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, announced that the first patients with severe Parkinson’s disease have been enrolled and dosed in a Phase 2a trial of ND0612H. ND0612H is a high-dose form of NeuroDerm’s proprietary liquid levodopa/carbidopa (LD/CD) drug formulation, delivered continuously through subcutaneous administration by a belt-pump.
“ND0612H is being developed for severe stage Parkinson’s disease patients who are refractory to oral levodopa and have only limited remaining treatment options such as continuous intra-duodenal LD/CD gel infusion and Deep Brain Stimulation. Both treatments require highly invasive surgical intervention and are associated with serious complications. Many patients, therefore, are either deterred or prevented from using them,” said Oded Lieberman, NeuroDerm’s CEO. “Because of its subcutaneous delivery route, ND0612H should offer these patients, for the first time, the advantage of continuous levodopa therapy without having to go through surgery that is required for alternative treatments. We hope that severe Parkinson’s patients will be able to benefit in the future from a widely accessible, highly effective new treatment alternative that may have a dramatic influence on their lives.”
The objective of this Phase 2a clinical study is to evaluate the pharmacokinetic profile and the steady state levodopa blood levels of different doses of ND0612H as well as of ND0612L, a low-dose form of liquid LD/CD for moderate stage Parkinson’s disease patients delivered through a similar belt-pump device.
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson’s disease by maintaining steady, therapeutic levodopa plasma levels in a convenient manner both day and night. ND0612H is intended to replace current treatments for patients with severe stage Parkinson’s disease that require highly invasive surgery associated with serious side effects.
ND0612L, the low dose drug form intended for moderate stage Parkinson’s disease patients, has just completed patient enrollment and treatment in a Phase 2 double-blind, randomized, placebo-controlled study supported by a grant from The Michael J. Fox Foundation for Parkinson’s Research. Top-line results from this study are expected in the fourth quarter of 2014.
ND0612L was shown in previous Phase 1 and Phase 2a studies to be safe and tolerable, reaching steady state, clinically meaningful levodopa blood concentrations.
Date: September 3, 2014