- Clinical Trial Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Two Dosing Regimens of ND0612 Compared With Oral Standard of Care Treatment in Patients With Advanced Parkinson’s Disease -
- Clinical and Pre-Clinical Data Investigating the Effect of Continuous Carbidopa Administration on Levodopa Plasma Levels Also Selected for Presentation -
- Preclinical Data for ND0701, NeuroDerm’s Investigational Continuous Subcutaneous Apomorphine Formulation for Advanced Parkinson’s Disease, Also Selected for Presentation -
REHOVOT, Israel, June 16, 2016 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (Nasdaq:NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that design of its ongoing Phase II clinical trial of ND0612H for the treatment of Parkinson’s diseases (trial 006), as well as other clinical and pre-clinical data on the effect of continuous carbidopa administration on levodopa plasma levels as well as pre-clinical data investigating ND0701, its new apomorphine product candidate for the treatment of Parkinson’s disease, will be presented at the 20th International Congress on Parkinson’s Disease and Movement Disorders taking place June 19 to June 23, 2016 in Berlin, Germany. ND0612H and ND0701, NeuroDerm’s investigational candidates for the treatment of severe Parkinson’s disease (PD), are continuously administered subcutaneous formulations of levodopa/carbidopa (LD/CD) and apomorphine.
Karl Kieburtz, MD, MPH, the Robert J. Joynt Professor in Neurology, Senior Associate Dean for Clinical Research and Director of the Clinical & Translational Science Institute at the University of Rochester Medical Center, will present a poster titled, “A randomized controlled clinical study to evaluate efficacy, safety and tolerability of SC L-dopa/carbidopa (ND0612H) infusion regimens in fluctuating PD patients,” (Abstract 1971). The poster will be presented in the Parkinson’s disease: Clinical trials, pharmacology and treatment session to be held 12:00 p.m. – 1:30 p.m. on June 23.
ND0612H’s first efficacy trial (trial 006), initiated in December 2015, is a multicenter, open-label, rater-blind Phase II study that will enroll 36 Parkinson's disease patients who experience at least 2.5 hours of “off” time per day and whose symptoms are not adequately controlled with oral medications. This trial is designed to investigate the safety, tolerability and pharmacokinetics of two regimens of ND0612H (continuous subcutaneous infusion over 24 or 14 hours) as well as their effect on “off” time in comparison to standard LD/CD therapy (change from baseline). Data presented will include the design and objectives of this study.
Oron Yacoby-Zeevi, PhD, DVM, VP R&D, will participate in a guided tour of a poster titled, “Continuous subcutaneous delivery of solubilized carbidopa improves the pharmacokinetic profile of levodopa” (Abstract 1973). The poster will also be presented in the session titled, “Parkinson’s disease: Clinical trials, pharmacology and treatment,” to be held from 12:00 p.m. to 1:30 p.m. on June 23. Presented data will include results from a series of pharmacokinetic studies in pigs, mice, and humans to characterize continuous subcutaneous carbidopa delivery co-administered with oral LD/CD on LD pharmacokinetics compared with oral LD/CD.
Dr. Yacoby-Zeevi will also present data from preclinical studies of ND0701 in a poster titled, “ND0701: A novel safe concentrated apomorphine formulation for continuous subcutaneous administration via a patch pump” (Abstract 1977). ND0701 is a drug candidate based on a novel, proprietary apomorphine formulation that was developed to have significantly better local tolerability and be approximately five times more concentrated than the current apomorphine-HCL based commercial products. ND0701 is designed to be administered through a small patch-pump and be a therapy alternative for advanced PD patients who suffer from high motor fluctuations and who do not respond well to LD/CD. The poster will be presented in the Parkinson’s disease: Clinical trials, pharmacology and treatment session to be held 12:00 p.m. – 1:30 p.m. on June 23. Presented data will include local site reactions following subcutaneous administration of ND0701 or apomorphine-HCL during a 24-hour period, and the apomorphine plasma concentrations reached in steady-state.
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
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD solution. Previously completed Phase II trials demonstrated that ND0612L maintained steady, therapeutic levodopa plasma concentrations that were associated with major changes 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 LD/CD Intestinal Gel.
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. Levodopa is the most effective treatment for Parkinson’s disease. However, chronic oral levodopa treatment is associated with fluctuations in motor response as result of which, despite the benefits of the drug, patients can experience periods of impaired 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 levodopa-treated Parkinson's disease patients and can interfere with day-to-day functions, causing patients to become severely disabled. Current evidence suggests that intermittent dosing with standard oral formulations of levodopa contributes to the development of these motor complications. By contrast, it has been shown that continuous administration of levodopa can effectively treat motor fluctuations in Parkinson's disease patients without increasing troublesome dyskinesia; however, a convenient route for 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. 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 levodopa and carbidopa (LD/CD) product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD 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.
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Oded S. Lieberman, PhD, CEO
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