NeuroDerm Ltd. Announces Enrollment in a Phase 2 Study of ND0612, a Continuous Levodopa/Carbidopa Drug for the Treatment of Parkinson's Disease
Published: Apr 15, 2013
In previous phase I studies, ND0612 was shown to be safe and tolerable and reached steady state, clinically meaningful levodopa concentrations for the first time in man. Furthermore, steady state levodopa concentrations were maintained in a practical manner during both day and night. The current Phase II double-blind, randomized placebo controlled study in Parkinson's disease patients will assess ND0612 for safety and tolerability as well as for levodopa and carbidopa steady state plasma levels.
"Following its success in phase I trials, ND0612 is now entering trials in patients. An important objective of this study will be to find out what steady state levodopa concentrations can be reached in patients. In healthy volunteers, ND0612 reached day and night steady state levodopa levels, the elusive holy grail of Parkinson's levodopa therapy, in a conveniently administered drug that should be available to all PD patients. Moreover, ND0612 bypasses the gastrointestinal tract and should be little influenced by intestinal absorption or oral ingestion of food or drugs. This trial marks a landmark in the development of ND0612, a novel levodopa drug that could become a breakthrough treatment option in Parkinson's Diseases."
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 levodopa. ND0612 is being developed for administration via a subcutaneous delivery patch as a new treatment and intervention option in Parkinson's disease treatment. It should significantly 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 cognitive disorders in diseases such as ADD/ADHD, schizophrenia and Alzheimer's disease. NeuroDerm is headquartered in the Weizmann Science Park, Ness Ziona, Israel.
Oded S. Lieberman, PhD MBA, Chairman & CEO
Tel.: +972-8-946 2729; Cell: +1-617-517 6077
SOURCE NeuroDerm Ltd