- An Encore Presentation on ND0612 Will be Given at the Invited Science: Movement Disorders Session Following the Identification of ND0612 Stable Levodopa Plasma Levels as a Critical Advance in the Field of Neuroscience -
- A Platform Presentation on the Effects of Continuously Delivered Carbidopa on Levodopa Bioavailability Compared to Oral Carbidopa Will Also be Presented at the Movement Disorders: Parkinson’s Disease Clinical Trials and Therapeutics Session -
REHOVOT, Israel, April 05, 2016 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (Nasdaq:NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that the Science Committee of the American Academy of Neurology (AAN) identified NeuroDerm’s submission for the Movement Disorders Congress, “Stable levodopa plasma levels with ND0612 (levodopa/carbidopa for subcutaneous infusion) in Parkinson’s disease (PD) patients with motor fluctuations,” as a critical advance in the field of neuroscience and selected the data for an encore presentation at the American Academy of Neurology 68th Annual Meeting taking place April 15-21 in Vancouver, BC, Canada.
Separately, pre-clinical and clinical data on the effect of continuous carbidopa on levodopa pharmacokinetics has been selected for a platform presentation.
Sheila Oren, MD, MBA, Vice President of Clinical & Regulatory Affairs at NeuroDerm, will present, at the invitation of the AAN, “Stable Levodopa Plasma Levels With ND0612 (Levodopa/Carbidopa for Subcutaneous Infusion) in Parkinson’s Disease (PD) Patients With Motor Fluctuations,” at 5:10 p.m. PT on April 19th in the Invited Science: Movement Disorders session. This new scientific session, organized in partnership with the International Parkinson and Movement Disorders Society, features clinically important work on movement disorders related topics. The results obtained with ND0612 were selected for this session, which highlights some of the most exciting advances in the movement disorders field.
The ND0612 Phase IIa data, most recently presented at the 19th International Congress of Parkinson’s Disease and Movement Disorders Annual Meeting in June 2015, demonstrated that NeuroDerm's subcutaneously administered levodopa and carbidopa (LD/CD) led to clinically-significant plasma levodopa levels. These results suggest that ND0612H, intended to maintain high, consistent and stable levodopa plasma levels in severe PD patients through simple sub-cutaneous delivery, may provide, in the majority of these patients, a safe and effective alternative to the current treatment options that require surgery.
Oron Yacoby-Zeevi, PhD, DVM, Vice President of R&D at NeuroDerm, will separately deliver a presentation, titled “Continuous Subcutaneous Administration of Carbidopa Enhances Levodopa Pharmacokinetics: A Series of Studies Conducted in the Pig, Mouse, and Healthy Volunteers,” (Abstract S40.002) at 1:15 p.m. PT on April 20th in a Scientific Platform Session on Movement Disorders: Parkinson’s Disease Clinical Trials and Therapeutics. These preclinical and clinical studies evaluated the impact of continuous subcutaneous carbidopa delivery on the pharmacokinetics of levodopa. The results show that continuous subcutaneous carbidopa delivery improves oral and subcutaneous levodopa bioavailability compared to oral carbidopa, and provide an additional rational and mechanism of action for the improved levodopa pharmacokinetic properties shown with ND0612.
About Levodopa
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, ND0612L
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.
About NeuroDerm
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. The company has three 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 are ND0612L and ND0612H, which are used for treatment of moderate and advanced Parkinson's disease patients, respectively, and which are delivered subcutaneously. In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from moderate to severe Parkinson's disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.
Forward-Looking Statements
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, 2015 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.
NeuroDerm Contact:
Oded S. Lieberman, PhD MBA, CEO
oded@neuroderm.com
Tel.: +972-8-946 2729
Cell: +1-617-517 6077
U.S. Investor Contact:
David Carey
Lazar Partners Ltd.
dcarey@lazarpartners.com
+212-867-1762