NESS ZIONA, Israel, March 4, 2013 /PRNewswire/ --
NeuroDerm, 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 scientific meeting.
"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.
About ND0612
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.
About NeuroDerm
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
oded@neuroderm.com
Tel.: +972-8-946-2729
Cell: +1-617-517-6077
3 Golda Meir St
Weizmann Park