NeuroDerm Ltd.
NDRM, a clinical-stage pharmaceutical company developing drugs for
central nervous system (CNS) diseases, today announced that continuous,
subcutaneous delivery of the company's proprietary liquid levodopa/carbidopa
(LD/CD) product candidates, ND0612H and ND0612L, led to clinically-significant
plasma levodopa levels. These results suggest that the high dose version,
ND0612H, intended for severe Parkinson's disease patients, may provide an
effective therapy alternative to current treatments requiring surgery.
"Maintaining consistent levodopa concentrations has been the most significant
hurdle in Parkinson's disease therapy," said Sheila Oren, MD, NeuroDerm's Vice
President of Clinical and Regulatory Affairs. "The results from this study
demonstrate that ND0612H can reach high LD plasma levels that, to date, could
only be reached and maintained by products that require surgical intervention.
ND0612H is designed to be delivered continuously, thus we believe it should
offer a simple and effective treatment option that will minimize the need for
surgical intervention in advanced Parkinson's patients."
Due to the short half-life of oral levodopa, patients are required to take
multiple LD/CD doses daily. This results in sharp fluctuations in levodopa
levels which are associated with erratic "off" and "on" periods experienced by
many patients. Continuous LD administration can overcome this limitation, but
steady LD delivery can currently only be achieved after undergoing an invasive
surgical procedure whereby a tube is permanently implanted into the duodenum,
the upper part of the small intestine.
The primary endpoints of the IIa study were to assess the safety, tolerability
and pharmacokinetics (PK) of six dose regimens of ND0612H and ND0612L, which
provide continuous, subcutaneously-delivered liquid LD/CD formulations through
a belt-worn pump, in Parkinson's disease patients. Sixteen (16) advanced PD
patients, with motor fluctuations, chronically treated with standard of care
oral LD/CD, were enrolled in the study and were treated with ND0612L (n=9) or
ND0612H (n=7) for eight hours per day, for three consecutive days, with high
and low doses of CD, and with adjunct oral entacapone. The pharmacokinetics of
LD/CD were assessed and compared to baseline pharmacokinetics of orally
administered, immediate release LD/CD tablets. A top-line, intent-to-treat
analysis showed that levodopa plasma levels were proportionate to dose and,
with ND0612H, achieved maximum daytime concentrations of 1,333ng/ml and
1,436ng/ml (with different CD concentrations in the formulation), and
1,807ng/ml with adjunct dosing of oral entacapone. ND0612L achieved maximum
daytime concentrations of 528ng/ml and 477ng/ml (with different CD
concentrations in the formulation), and 596ng/ml with adjunct dosing of oral
entacapone. Fluctuations in LD plasma levels were markedly reduced when
comparing oral LD/CD dosing to ND0612H and ND0612L. Per-protocol analysis,
that omitted three data sets from two patients because of concomitant use of
oral LD, yielded similar LD plasma values.
Treatment with ND0612L and ND0612H did not raise safety and tolerability
concerns, causing only minimal and transient local reactions at the infusion
site and no particular systemic adverse events, which corroborates the results
obtained in previous studies. All patients completed the study.
"These results add to the growing body of clinical data confirming our thesis
that continuous, subcutaneous delivery of LD/CD leads to more consistent
therapy, which we expect to have a dramatic effect on patient outcomes and
quality of life, replacing in most cases the need for surgical intervention,"
said Oded S. Lieberman, PhD, CEO of NeuroDerm. "Based on these positive PK
results, we will proceed with the clinical development of ND0612H and ND0612L
in the United States and the European Union in 2015."
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