NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for CNS disorders, announced the start of patient enrollment in a first efficacy trial of ND0612H, the company’s continuously administered subcutaneous levodopa/carbidopa solution. This treatment is intended to be an alternative to current treatments for patients with advanced Parkinson’s disease that require surgical intervention.
The multicenter international phase II clinical study will compare the efficacy, safety and tolerability of ND0612H to the baseline oral standard of care. ND0612H, administered through a belt pump, is designed to deliver steady LD/CD levels and improve motor fluctuations that cannot be adequately controlled with oral therapy and might otherwise require surgical intervention.
"Previous studies demonstrated that continuous subcutaneous delivery of ND0612H has the capacity to produce stable plasma levodopa levels that currently can be reached and maintained only by treatments that require invasive surgery. In other studies the company demonstrated that continuous subcutaneous delivery of the low dose product, ND0612L, as an add-on, can improve motor fluctuations without causing an increase in dyskinesia, benefits that are similar to those obtained with invasive therapy such as deep brain stimulation and LD/CD intestinal gel, but avoiding the potentially serious side effects associated with those procedures,” said C. Warren Olanow, MD, Professor of Neurology and of Neuroscience at the Mount Sinai School of Medicine in New York City.
“This trial is intended to produce additional evidence that ND0612H is a viable alternative for advanced Parkinson’s patients who suffer motor complications that can no longer be satisfactorily controlled with current optimized therapies.”
This 28 day multicenter, parallel-group, rater-blinded, randomized pilot phase II study (designated 006) will investigate the efficacy, safety, tolerability and pharmacokinetics of two dosing regimens of ND0612H and compare them to the baseline oral standard of care. The study is expected to enroll a total of 36 advanced Parkinson’s disease patients.
"This first efficacy trial of ND0612H marks an important milestone in its clinical development. Advanced Parkinson’s disease patients who suffer motor complications that cannot be adequately controlled with current therapy face limited treatment options that include surgical intervention that may be associated with serious adverse effects and death. NeuroDerm is committed to provide advanced stage patients with a new therapy option that will be a safe, simple and effective alternative to current surgical treatments,” said Oded S. Lieberman, PhD, MBA, CEO of NeuroDerm.
The company is proceeding on track in Europe with a head-to-head pharmacokinetic (PK) comparison study of ND0612H and Duodopa, the results of which are expected in Q2 2016. The company is also planning to initiate a phase III pivotal efficacy trial for its ND0612L treatment for patients with moderate to severe Parkinson’s disease as well as a long-term safety follow-up in the first half of 2016.
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.
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 dyskinesias; however, a convenient route for continuous administration has not been introduced to date.