REHOVOT, Israel, June 18, 2015 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (Nasdaq:NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, announced that its poster presentation, "Stable levodopa plasma levels with ND0612 (LD/CD for subcutaneous infusion) in Parkinson's disease (PD) patients with motor fluctuations," has been selected as part of the 19th International Congress of Parkinson's Disease and Movement Disorders Blue Ribbon Highlights Session, which was held today in San Diego. Chosen by a panel of experts from nearly 1,500 poster presentations, the Blue Ribbon Session provides a critical review of the best poster presentations, highlighting relevance, novelty and quality of both clinical data and basic research, according to the International Parkinson and Movement Disorder Society. The presentation had previously been accepted as a late-breaking poster.
"Being selected to the Blue Ribbon Highlights Session is an exceptional honor for NeuroDerm as it underscores peer acknowledgement that NeuroDerm's clinical results with its lead product candidates represent the best and most exciting work at this conference this year, and that NeuroDerm's product candidates may lead to future breakthroughs in the treatment of Parkinson's disease," said Oded Lieberman, PhD, MBA, CEO. "More importantly, the data presented at this meeting emphasizes NeuroDerm's potential to offer greatly improved future treatment options, including the prospect of an effective, non-surgical treatment alternative for advanced patients that currently face only limited, highly-invasive treatment options, condemning many of them to a debilitating and devastating life with Parkinson's disease."
Previously presented results demonstrated that NeuroDerm's subcutaneously administered LD/CD led to clinically-significant plasma levodopa levels that suggest that the high dose version, ND0612H, intended to maintain high, consistent and stable levodopa plasma levels in severe Parkinson's disease patients, may provide an effective therapeutic alternative in most patients to the current treatment options that require surgery. In this poster additional statistical analyses were presented that reinforce the marked reduction of fluctuations in levodopa plasma levels and enhance the good safety and tolerability profile.
The company also presented data from a previously presented Phase II study, "Pharmacokinetic profile of ND0612L (levodopa/carbidopa for subcutaneous infusion) in patients with moderate to severe Parkinson's disease," which also demonstrated that subcutaneous continuous delivery of LD/CD with ND0612L, the low dose version intended to treat moderate stage Parkinson's patients, provides relatively stable levodopa levels with reduced variability compared with orally administered levodopa. Patients treated with ND0612L consistently maintained their plasma LD concentration above a high minimum threshold, showed a lower peak-to-trough ratio and lower fluctuation index. Exploratory efficacy analysis showed that ND0612L treatment markedly reduced off time and markedly improved quality of life and quality of sleep.
Oral administration of LD/CD is regarded as the "gold standard" treatment for patients suffering from Parkinson's disease. Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels. Virtually all patients diagnosed with Parkinson's disease will require levodopa at some point over the course of their treatment for the disease, and 70% to 80% of patients receive the drug at any given point in time. However, levodopa is limited by its short half-life. Approximately three to four hours after a single dose, almost none of the drug remains in the plasma. In addition, levodopa suffers from low absorption when administered orally, with only about 30% of the levodopa entering the blood stream.
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD, maintaining steady, therapeutic levodopa plasma concentrations both day and night.
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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