NESS ZIONA, Israel, June 19, 2013 /PRNewswire/ --
NeuroDerm, Ltd. today announced that results from a phase I study in volunteers, and preliminary results from a phase IIA study in advanced Parkinson's patients, of ND0612, were presented at the 2013 International Congress of Parkinson's Disease and Movement Disorders. ND0612 is a proprietary levodopa/carbidopa liquid drug formula under development for continuous administration through a sub-cutaneous (SC) delivery patch that would maintain constant levodopa plasma concentrations.
ND0612 has been shown in both trials to be safe and tolerable and, for the first time in man, to maintain steady state, clinically meaningful levodopa plasma concentrations. ND0612 can be administered subcutaneously in a convenient manner and has the potential to significantly improve the current standard of treatment of Parkinson's disease patients.
"We are encouraged by ND0612's potential to achieve steady state levodopa plasma levels both day and night and by its potential to become a widely accessible drug. Based on the positive data, as well as on discussions with the Food and Drug Administration, NeuroDerm is planning to continue the clinical development of ND0612 and initiate advanced clinical trials with ND0612 in the coming months", said Oded S. Lieberman, PhD, NeuroDerm's CEO.
Constant Therapeutic Levodopa Plasma Concentrations Maintained by Continuous Subcutaneous Administration of ND−0612, a Novel Formulation of Levodopa/Carbidopa
Y. Caraco, S. Oren, P. LeWitt
HCRC, Hadassah Medical Center, Jerusalem, Israel; Neurology, Wayne State University and Henry Ford Hospital, West Bloomfield, Michigan, USA; NeuroDerm, Ltd, Ness Ziona, Israel
Data from 54 volunteers showed that continuous SC delivery of ND0612 is safe, tolerable and achieved dose dependent, constant, LD plasma concentrations. ND0612 decreased LD plasma fluctuations and its peak-to-trough ratio and could be administered at differing day and night infusion rates. ND0612 could also be administered together with other oral PD medications such as entacapone.
Additional key findings presented include:
ND0612, A Novel Formulation Of Levodopa/Carbidopa For Continuous, Subcutaneous Administration, Achieves Steady-State Levodopa Plasma Concentrations In Parkinson's Disease Patients
Y. Caraco, S. Oren, O. Yacoby-Zeevi, P. LeWitt, N. Giladi
Clinical Pharmacology Unit, Hadassah University Hospital, Jerusalem, Israel; NeuroDerm, Ltd, Ness Ziona, Israel;Neurology, Wayne State University and Henry Ford Hospital, West Bloomfield, Michigan, USA; Neurology, Tel Aviv Medical Center and Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
Preliminary data from 8 advanced Parkinson's disease patients showed that subcutaneous ND0612 delivery achieved steady-state plasma LD concentrations ranging from 700-900 ng/ml (which is a typical therapeutic range). Fluctuations in LD plasma concentration were significantly reduced. With ND0612, LD concentration could be adjusted by controlling the infusion rate (programmed during day and night) and by adding oral LD/CD and a COMT inhibitor. Peripheral catechol-O-methyl transferase (COMT) was probably the main metabolic pathway acting on LD. The amount of entacapone provided in Stalevo® was apparently insufficient to inhibit the extensive COMT activity. Therefore, we conclude that, with ND0612, additional inhibition of COMT would further contribute to increasing plasma LD concentration.
Additional preliminary key findings presented include:
About Parkinson's Disease
Parkinson's disease affects approximately 6M 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 through the oral route, 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 the main challenge of Parkinson's drug therapy, and ways to achieve this have been under investigation for several decades.
ND0612 is based on a proprietary sub-cutaneous levodopa/carbidopa drug formulation that bypasses the digestive tract. It continuously delivers levodopa to achieve straight-line and clinically-significant levodopa blood levels. It also delivers subcutaneous carbidopa to improve the bioavailability of levodopa. ND0612 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 that achieve better efficacy. The company's lead products are ND0611 and ND0612, novel sub-cutaneous drug formulations for the treatment of Parkinson's disease, and ND0801, a combination drug for the treatment of cognitive disorders in diseases such as ADD/ADHD, schizophrenia and Alzheimer's disease. NeuroDerm is headquartered in the Weizmann Science Park, Ness Ziona, Israel.
Oded S. Lieberman, PhD MBA, Chairman & CEO
Tel.: +972-8-946 2729; Cell: +1-617-517 6077
|SOURCE NeuroDerm Ltd|
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