NeuroDerm Announces Positive Results of a Phase I Study of ND0612 for the Treatment of Parkinson’s Disease
NESS ZIONA, Israel, March 4, 2013 /PRNewswire/ –
NeuroDerm [http://www.neuroderm.com ], Ltd. announced today the results of a Phase I
safety and pharmacokinetic trial of ND0612, a novel drug formulation for the treatment of
Parkinson’s disease. ND0612 is a proprietary levodopa/carbidopa liquid formula
administered continuously sub-cutaneously through a patch pump. It is designed to provide
steady levodopa blood levels for the reduction of motor complications in Parkinson’s
disease. Results of this study support the continued development of ND0612 for the
treatment of Parkinson’s disease.
In this double-blind, placebo controlled, dose-escalation trial in young, healthy
volunteers, ND0612 was shown to be safe and tolerable in all of the tested doses.
Furthermore, clinically meaningful levodopa concentrations were reached and, for the first
time in man, steady state levodopa concentrations were maintained in a practical manner
both day and night. The full results of this study will be presented at a future
“ND0612′s success in its first phase I trial means that clinically significant steady
state levodopa concentrations can, for the first time, be maintained, both day and night,
through a conveniently administered drug. With ND0612, steady state levodopa levels, the
elusive holy grail of Parkinson’s levodopa therapy, should be available to all PD
patients. Moreover, as ND0612 bypasses the gastrointestinal tract, steady state levodopa
levels should be little influenced by intestinal absorption or oral ingestion of food or
drugs. We believe that ND0612 could become a breakthrough treatment option that may
establish a new, significantly higher standard of care for Parkinson’s patients.”
About Parkinson’s Disease
Parkinson’s disease affects approximately 6 million 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 together with a levodopa degradation inhibitor (usually, carbidopa). When
administered through the oral route, however, levodopa plasma concentrations undergo sharp
fluctuations reaching high peaks and low troughs that contribute to the clinical and motor
complications in Parkinson’s patients.
ND0612 is a proprietary formulation of levodopa and carbidopa administered through a
pump patch that enables, for the first time, to conveniently achieve steady state levodopa
plasma levels. Levodopa and carbidopa (traditionally co-administered with levodopa to
prevent its breakdown) are nearly always administered orally and suffer from an
unfavorable pharmacokinetic profile due to short half life and low bioavailability.
Continuous subcutaneous delivery of levodopa and carbidopa is a novel approach designed to
improve their pharmacokinetic profile and maintain stable, therapeutic levodopa plasma
concentrations, thereby significantly ameliorating motor fluctuations and non-motor
complications in Parkinson’s disease.
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 whose low bio-availability is the major impediment to
better efficacy. The company’s lead products are ND0612 and ND0611, revolutionary SC drugs
for the treatment of Parkinson’s disease and ND0801, a combination patch for the treatment
of ADD/ADHD. Other programs focused at other diseases, including schizophrenia and
Alzheimer’s disease, are in different stages of development. NeuroDerm is headquartered in
the Weizmann Science Park, Ness Ziona, Israel.
Contact: Oded S. Lieberman, PhD MBA, Chairman & CEO firstname.lastname@example.org Tel.: +972-8-946-2729 Cell: +1-617-517-6077 3 Golda Meir St Weizmann Park P.O. Box 4150 Ness Ziona 74140, ISRAEL Tel. +972-8-9462729 Fax. +972-8-9461729
SOURCE NeuroDerm Ltd