REHOVOT, Israel, June 11, 2015 (GLOBE NEWSWIRE) -- NeuroDerm, Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today announced that it has started a pharmacokinetic (PK) clinical study to determine the dosing of the company's lead product candidate, ND0612H, a subcutaneously administered liquid formulation of levodopa (LD) and carbidopa (CD), for the treatment of advanced Parkinson's Disease.
"ND0612H is the first liquid levodopa/carbidopa (LD/CD) formulation designed to maintain steady levodopa plasma levels that can be administered through simple subcutaneous delivery. This study represents a significant clinical milestone for NeuroDerm as its results may allow ND0612H to be developed in Europe on the basis of PK similarity studies rather than full-scale efficacy studies," said Oded S. Lieberman, PhD, MBA, CEO of NeuroDerm. "Should the data from this trial support an abbreviated PK-based development of ND0612H in Europe, it would facilitate our efforts to make ND0612H available to patients as early as possible. We remain committed to bring to the market a simple, effective, subcutaneously-delivered LD/CD treatment alternative that, in the majority of advanced Parkinson's disease patients, would replace the need for the currently available highly invasive therapies that require surgical intervention."
This open-label, dose finding, PK study is expected to enroll a total of 24 healthy volunteers. In this study, the PK of subcutaneously administered ND0612H will be compared with that of Duodopa® intestinal gel, a product that requires surgical intervention. Results of this study are expected in the second half of 2015 and, if successful, will be used to design and conduct a follow-up, definitive PK similarity study in healthy volunteers.
"We look forward to the results of this much anticipated Phase II clinical study. Pending its final outcome and data analysis, we hope to soon thereafter initiate the definitive PK similarity study comparing ND0612H to Duodopa® that was required by the EMA as the basis for approval in Europe," added Dr. Lieberman.
In October 2014, the European Regulatory Authority (EMA) confirmed that it had agreed with NeuroDerm's proposal that a PK study comparing ND0612H with Duodopa® in healthy volunteers may constitute the basis for approval in Europe. If the company is successful in demonstrating in such studies that ND0612H produces similar PK profiles to Duodopa®, then a reduced clinical data package would be the basis for a marketing approval of ND0612H in Europe through a Centralized Procedure.
In December 2014, NeuroDerm announced topline results of its Phase IIa pharmacokinetic study of ND6012H and ND0612L, showing that continuous, subcutaneous delivery of its LD/CD product candidates led to clinically significant steady plasma levodopa levels. It further showed that ND0612H produced high plasma levodopa levels that, to date, could only be reached and maintained by products that require surgical intervention, such as Duodopa®. These results reinforced the assumption that ND0612H could provide an effective treatment alternative to highly invasive current therapies that involve surgical intervention such as Deep Brain Stimulation (DBS) and Duodopa/Duopa®.
A Phase II clinical efficacy study of ND0612H is also planned to commence in the United States in the second half of 2015.
ND0612H and ND0612L
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD. Recently completed phase II trials demonstrated that ND0612L maintained steady, therapeutic levodopa plasma concentrations that were associated with major improvements in several clinical parameters including "off time" reductions when added to optimized oral standard of care. ND0612H, intended for severe Parkinson's disease patients, was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to current treatments requiring surgery such as deep brain stimulation and Duodopa/Duopa®.
About Parkinson's disease
Parkinson's disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a debilitating decrease in the patient's motor and non-motor functions. Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient's quality of life. As the disease progresses, these symptoms become more severe, resulting in debilitating periods of decreased motor and non-motor functions, also referred to as "off" time. In addition, mainly as a result of excessive/intermittent oral doses of levodopa aimed at treating the "off" time, some patients experience involuntary movements, or dyskinesia. The "off" time and dyskinesia affect the majority of Parkinson's disease patients and interfere with day-to-day functions, causing patients to become severely disabled. Continuous administration of levodopa has been shown to effectively treat motor fluctuations in Parkinson's disease patients, however, a convenient route of continuous administration has not been introduced to date.
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 in Rehovot, Israel
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties. Such forward-looking statements may include projections regarding our future performance and may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under "Risk Factors" in our annual report on Form 20-F for the year ended December 31, 2014 filed with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Oded S. Lieberman, PhD, MBA, CEO
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