NeuroDerm, Ltd. was informed today that it was awarded a grant of $1M by The Michael J. Fox Foundation for Parkinson's Research. These funds will support the next clinical study with ND0611, a new dermal patch for the treatment of Parkinson's disease, as part of the Foundation's prestigious Clinical Intervention Awards 2010 program. This study will evaluate the safety, tolerability, levodopa pharmacokinetics, and possible clinical benefits of ND0611 in advanced Parkinson's disease patients.
ND0611 is a proprietary drug formula that enables, for the first time, the continuous administration of carbidopa via a sub-cutaneous dermal patch. Carbidopa is conventionally administered orally with levodopa to prevent its breakdown. In pre-clinical studies, plasma levodopa concentration profiles showed markedly less fluctuation after continuous administration of ND0611. The levodopa area-under-the-curve values and trough concentrations were greatly increased when ND0611 was administered together with standard levodopa products (Sinemet(R), Stalevo(R) and Sinemet(R) CR). This effect was achieved through an as-yet unclear mode of action that may involve a novel levodopa metabolic pathway. Subcutaneous carbidopa delivery may permit more continuous levels of levodopa to be maintained in the brain, thus helping to manage motor fluctuations in Parkinson's disease patients.
"The enormous show of confidence by The Michael J. Fox Foundation for Parkinson's Research in this new therapeutic approach for Parkinson's disease strengthens our efforts to develop innovative treatments for the many unmet needs of patients with this disorder," said Oded S. Lieberman, PhD, NeuroDerm's Chairman and CEO. "It also underscores NeuroDerm's deep commitment and expertise in the development of novel therapeutics for diseases of the central nervous system."
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