NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today announced the start of patient enrollment in a long-term safety study (trial 012) of the company’s continuously administered subcutaneous levodopa/carbidopa (LD/CD) formulation used in both ND0612H and ND0612L.
The one-year international, open label study will investigate the long-term safety of low and high dose regimens of ND0612. The study is expected to enroll approximately 100 patients, including patients who have previously completed the company’s phase 2 and 3 studies as well as new patients. At least 50 patients will be treated with the highest dose regimen. ND0612, continuously administered through a belt pump, is designed to maintain steady LD/CD levels to improve motor fluctuations that cannot be adequately controlled with oral therapy and, in the case of advanced patients, provide an alternative to treatments requiring surgical intervention.
“This trial is intended to produce long-term evidence of the safety profile of ND0612 as a viable new treatment option for patients with Parkinson’s disease, and a non-surgical alternative for advanced patients who suffer motor complications, who can no longer be controlled with current best standard of care oral therapies,” said Sheila Oren, MD, MBA, Vice President of Clinical and Regulatory Affairs of NeuroDerm. “Previous shorter-term studies with ND0612 have shown clinical benefits that were similar to those obtained with invasive surgical procedures while exhibiting a good safety profile, in contrast to the potentially serious and sometimes life-threatening side effects associated with invasive surgical therapies such as deep brain stimulation and LD/CD intestinal gel.”
“This long-term safety trial marks another important milestone for NeuroDerm and the clinical development of ND0612. Upon the completion of this trial anticipated in 2017, as well as the other parallel trials outlined in our clinical development plan, we intend to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). We believe that ND0612 has the potential to become a simple therapy alternative that will offer significant new benefits for both moderate and advanced Parkinson’s disease patients who suffer motor complications that cannot be adequately controlled with current therapy,” said Oded Lieberman, PhD, MBA, CEO of NeuroDerm.
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.