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 may offer a new treatment alternative that can be widely adopted for chronic control of the most common problems affecting Parkinson's disease."
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