NESS ZIONA, Israel, June 1, 2010 /PRNewswire/ — NeuroDerm,
Ltd. announced today the successful enrollment and dosing in its
Phase I clinical trial of ND0611. ND0611, a proprietary drug
formula administered via a dermal patch, is designed to maintain
continuous therapeutic levodopa concentrations for improving the
treatment of Parkinson’s disease.
ND0611 increases levodopa bioavailability and extends its
effects by administering a novel pharmaceutical. Previous animal
studies found that ND0611 modified levodopa pharmacokinetics by (i)
increasing levodopa plasma half-life and area-under-the-curve
(AUC), (ii) maintaining levodopa plasma concentrations in a typical
therapeutic range, and (iii) extending dopaminergic stimulation in
the brain. ND0611’s mode of action involves an under-exploited
levodopa metabolic pathway and has the potential for markedly
improving clinical benefits from levodopa (the most effective drug
for Parkinson’s disease).
This Phase 1 study was conducted in healthy volunteers with the
purpose of measuring the safety and tolerability of ND0611 at
different doses. Further analysis will be completed to determine
the pharmacokinetic profile of levodopa in plasma. The company
expects to present the results of this phase 1 study in the second
half of 2010.
“The completion of this first step in the clinical development
of ND0611 marks an important milestone in the path to develop a new
therapeutic alternative for Parkinson’s disease patients,” said
Oded S. Lieberman, PhD, NeuroDerm’s
Chairman and CEO. “While constant levodopa plasma concentrations
achieved through continuous levodopa infusion have been shown to
bring significant benefit to Parkinson’s patients, these options
are generally impractical. In contrast, ND0611
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