NeuroDerm Announces Enrollment in a Phase 1 Study of ND0612, a Continuous Levodopa/Carbidopa Drug for the Treatment of Parkinson’s Disease
Ness Ziona, November 20, 2012 / — NeuroDerm, Ltd. announced today that enrollment of healthy subjects is ongoing in its Phase I clinical trial of ND0612, a novel drug formulation for the treatment of Parkinson’s disease. ND0612 is a proprietary levodopa/carbidopa liquid formula administered continuously via a subcutaneous delivery patch device. It is designed to provide steady levodopa blood levels and enhanced bioavailability of oral levodopa for the reduction of motor complications in Parkinson’s disease.
In pre-clinical studies of ND0612, plasma concentrations of levodopa reached straight-line steady state levels. The current Phase I double-blind, dose-escalation trial in young, healthy volunteers will assess ND0612 for safety and tolerability as well as for levodopa and carbidopa steady state plasma levels.
“This first trial of ND0612 in man is a significant step in the development of a new levodopa treatment standard for Parkinson’s disease” said Oded S. Lieberman, PhD, NeuroDerm’s Chairman and CEO. “For many years, oral levodopa has been the leading Parkinson’s disease drug therapy. However, due to low and erratic oral levodopa bioavailability, advanced Parkinson’s patients suffer from debilitating motor complications even under the best current standard of care. Should ND0612 achieve constant levodopa base blood levels, than low, harmful levodopa trough levels would be prevented, the efficacy of current levodopa therapy could be significantly raised and a new standard of care in our ability to treat and reduce motor complications in Parkinson’s disease patients may be established”.
About Parkinson’s Disease
Parkinson’s disease affects approximately 6M patients in the world. It is caused by decreasing dopamine signaling in the brain as dopaminergic brain cells die off. Levodopa is the “Gold Standard” therapy for Parkinson’s disease and virtually all patients receive it. When administered through the oral route, however, levodopa combined with a decarboxylase inhibitor (carbidopa or benserazide) demonstrates a short clearance half-life and low bioavailability that contribute to motor complications in Parkinson’s disease patients. Stable levodopa blood levels have been regarded as the “Holy Grail” of Parkinson’s drug therapy, and ways to achieve this have been under investigation for several decades.
ND0612 is based on a proprietary sub-cutaneous levodopa/carbidopa drug formulation that bypasses the digestive tract. It continuously delivers levodopa to achieve straight-line and clinically-significant levodopa blood levels. It also delivers subcutaneous carbidopa to improve the bioavailability of oral levodopa. ND0612 is being developed for administration as an adjunct to oral levodopa via a subcutaneous delivery patch as a new treatment and intervention option in Parkinson’s disease treatment. It should reduce off-time and improve the management of motor fluctuations even in patients under the best current standard of care with oral levodopa therapy.
NeuroDerm is an emerging pharmaceutical company that develops therapies for the treatment of CNS diseases. NeuroDerm’s technology is based on proprietary reformulations of well established oral drugs to achieve better efficacy. The company’s lead products are ND0611 and ND0612, novel sub-cutaneous drug formulations for the treatment of Parkinson’s disease and ND0801, a combination drug for the treatment of ADD/ADHD. Other programs, including those focused at schizophrenia and Alzheimer’s disease, are in different stages of development. NeuroDerm is headquartered in the Weizmann Science Park, Ness Ziona, Israel.