In previous phase I and phase IIa studies, ND0612L was shown to be safe and tolerable and reached steady state, clinically meaningful levodopa concentrations. Furthermore, it was demonstrated that the levodopa concentrations could be preset to reach different day and night levels. The current Phase II double-blind, randomized placebo controlled study in Parkinson’s disease patients will assess ND0612L in 30 Parkinson’s disease patients over a period of 21 days for safety, tolerability, levodopa and carbidopa steady state plasma levels, and exploratory clinical parameters. This trial is supported by a grant of $1M by The Michael J. Fox Foundation for Parkinson’s Research, the second $1M grant from the Foundation to NeuroDerm’s continuous SC administration dopaminergic program.
“Following its success in earlier phase I and phase IIa trials, ND0612L is now entering more advanced phase II trials in patients. An important objective of this study will be to asses longer term steady state levodopa concentrations in patients and obtain a first impression of their effect on the patients” said Oded S. Lieberman, PhD, NeuroDerm’s CEO. “ND0612L bypasses the gastrointestinal tract, should not be influenced by intestinal absorption or oral ingestion of food or drugs, and is administered in a controlled, predetermined rate both day and night – a treatment mode that has not been available to date to Parkinson’s patients. This trial marks an important step in the development of ND0612L that could become a breakthrough treatment option for Parkinson’s disease patients.”
About Parkinson’s Disease
Parkinson’s disease affects approximately six million 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 orally, 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.
ND0612L is based on a proprietary subcutaneous levodopa/carbidopa drug formulation that bypasses the digestive tract. It continuously delivers levodopa to achieve straight-line and clinically-significant levodopa blood levels both day and night. It also delivers subcutaneous continuous carbidopa to further improve the bioavailability of levodopa. ND0612L 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 is developing several novel subcutaneous drug formulations for the treatment of Parkinson’s disease and a combination drug for the treatment of cognitive disorders in diseases such as ADD/ADHD, NeuroDerm is headquartered in the Weizmann Science Park, Ness Ziona, Israel.