NeuroDerm Announces Start of Phase 2a Study of Continuous Subcutaneous Liquid Levodopa/Carbidopa Administration for Patients with Severe Parkinson’s Disease
Continuous levodopa therapy with ND0612H has the potential to prevent or delay the need for surgical intervention in patients with severe stage Parkinson’s disease
REHOVOT, September 03, 2014 / — NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that the first patients with severe Parkinson’s disease have been enrolled and dosed in a Phase IIa 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 S. Lieberman, PhD, 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 IIa 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 II 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 I and phase IIa studies to be safe and tolerable, reaching steady state, clinically meaningful levodopa blood concentrations.
About Parkinson’s Disease
Parkinson’s disease affects approximately 5 million patients worldwide. It is caused by decreasing dopamine signaling in the brain as dopaminergic brain cells die off. Levodopa is the “Gold Standard” therapy for Parkinson’s disease and virtually all patients receive it, together with a levodopa degradation inhibitor (usually carbidopa). When administered through the oral route, however, levodopa plasma concentrations undergo sharp fluctuations reaching high peaks and low troughs that contribute to the clinical and motor complications in Parkinson’s patients. In advanced Parkinson’s disease patients, oral levodopa therapy becomes ineffective, leaving patients with limited treatment options that are highly invasive and/or burdensome such as deep brain stimulation or intra-duodenal LD/CD gel infusion.
Our product candidates, ND0612L and ND0612H, are the first liquid formulations of levodopa and carbidopa to be administered subcutaneously to conveniently achieve steady state levodopa plasma levels. Levodopa and carbidopa are nearly always administered orally and suffer from an unfavorable pharmacokinetic profile associated with this administration route. NeuroDerm’s proprietary technology for continuous subcutaneous delivery of liquid levodopa and carbidopa is a novel approach designed to improve the drugs’ pharmacokinetic profile and maintain stable, therapeutic levodopa plasma concentrations, thereby significantly ameliorating motor fluctuations and non-motor complications in Parkinson’s disease.
NeuroDerm is a clinical-stage pharmaceutical company developing central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. In Parkinson’s disease, the company has four product candidates in different stages of development which offer a solution for almost every Parkinson’s disease patient from the moderate to the very severe stage of the disease. The company has developed a line of LD/CD product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD line of product candidates includes: ND0612L and ND0612H, delivered subcutaneously, for moderate and for advanced Parkinson’s disease patients, respectively, and ND0680 for a subset of severe Parkinson’s disease patients whose symptoms have advanced to a highly advanced stage, requiring even higher doses of LD/CD. In addition NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from severe Parkinson’s disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park, Rehovot, Israel.
Oded S. Lieberman, PhD MBA, CEO
Tel.: +972-8-946 2729
Cell: +1-617-517 6077
U.S. Investor Contact:
Lazar Partners Ltd.
U.S. Media Contact:
Lazar Partners Ltd.