NeuroDerm Presents at the 14th European Federation of Neurological Societies Meeting and the 2nd World Parkinson’s Congress
NESS ZIONA, Israel, September 28th, 2010 / —NeuroDerm, Ltd. announce today that a platform presentation highlighting the company’s new dermal patch for the treatment of Parkinson’s disease, ND0611, was given yesterday at the 14th Congress of the European Federation of Neurological Societies in Geneva, Switzerland. A poster presentation will be given at the 2nd World Parkinson’s Congress in Glasgow, Scotland. (Sep 28th – Oct 1st, 2010).
The presentation described results of pre-clinical studies and preliminary clinical results of the phase I trial for ND0611, a proprietary drug formula for the continuous administration of carbidopa via a sub-cutaneous dermal patch. Professor Peter A. LeWitt, MD, presented data showing that, in pre-clinical studies fluctuations in plasma levodopa concentration profiles lessened markedly after continuous administration of ND0611. The levodopa half-life, area-under-the-curve values and trough concentrations after oral dosing were greatly increased when ND0611 was administered together with standard levodopa products, such as Sinemet®, Stalevo® and Sinemet® CR. In a phase I study in young, healthy volunteers, ND0611 proved safe and tolerable. When administered together with Sinemet®, preliminary analysis of levodopa plasma levels showed that several pharmacokinetic parameters – including levodopa area-under-the-curve, half-life, time with concentrations above 1000ng/ml, and trough levels – improved. This effect was achieved through an as-yet unclear mode of action that may involve a novel levodopa metabolic pathway.
ND0611, when administered together with oral levodopa medications, might permit more continuous levels of levodopa to be maintained in the brain, thus helping to manage motor fluctuations in Parkinson’s disease patients. “Following the encouraging safety, tolerability and pharmacokinetic results of the phase I clinical study we look forward to proceeding with the clinical development of ND0611,” said Sheila Oren, MD MBA,Vice President of Clinical and Regulatory Affairs at NeuroDerm. “ND0611 represents a novel approach to improving the bioavailability of oral levodopa and might provide a new treatment option with a significant clinical benefit to patients with Parkinson’s disease.”
NeuroDerm is an emerging pharmaceutical company that develops novel therapeutic dermal patches for the treatment of CNS diseases. NeuroDerm’s technology is based on proprietary reformulations of well-established oral drugs, whose low bioavailability is the major impediment to better efficacy. The company’s lead product is ND0611, a revolutionary skin patch for the treatment of Parkinson’s disease. Additional products for the treatment of Parkinson’s disease, ADD, ADHD, schizophrenia and Alzheimer’s disease are in different stages of development. NeuroDerm is headquartered in the Weizmann Science Park, Ness Ziona, Israel.