NeuroDerm Beginns Patient Enrollment In PHase 2 Trial Of NDO612H FOr Advanced Parkinson's Disease

NeuroDerm Ltd. NDRM, a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today 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(R), 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.