NeuroDerm ND0612H Phase II Trial Results to be Presented in Late-Breaking Session at the 21st International Congress of Parki...
23 Mai 2017 - 1:00PM
- ND0612 head-to-head pilot PK results and ND0701
first-in-man PK results to also be presented -
NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical
company developing drug-device combinations for central nervous
system (CNS) disorders, today announced that complete data from
trial 006 will be showcased in a late-breaking poster session at
the 21st International Congress of Parkinson’s Disease and Movement
Disorders, taking place June 4-8, 2017 in Vancouver, B.C. Trial 006
was an international open label, blinded rater, phase II study of
ND0612H, NeuroDerm's high dose continuous, subcutaneously
delivered levodopa/carbidopa (LD/CD) liquid formulation, in
patients with advanced Parkinson's disease. ND0612 will be featured
in five additional abstracts, and data from pharmacokinetic (PK)
studies of ND0701 will also be presented.
In March 2017, NeuroDerm announced that a
preliminary analysis of trial 006 demonstrated that the trial
successfully met its primary, key secondary and additional
secondary endpoints, with many patients experiencing a complete
reduction of OFF-time to zero. Sheila Oren, MD, MBA, Chief Medical
Officer at NeuroDerm will present the complete results from this
trial in a poster titled, “Safety, efficacy and tolerability of
continuous SC LD/CD (ND0612) infusion in PD patients with motor
fluctuations,” (Abstract LBA41) in a late-breaking abstract session
on Wednesday, June 7, from 1:15 p.m. to 2:45 p.m. PT.
Tami Rachmilevitz MD, Medical Director at
NeuroDerm will present additional data from trial 006 in an
abstract titled, “Baseline characteristics of the population
enrolled to a randomized clinical study of subcutaneous
levodopa/carbidopa (ND0612) infusion in patients with advanced PD,”
(Abstract 1377) in a poster session on Thursday, June 8, from 1:15
p.m. to 2:45 p.m. PT.
Previously unannounced complete results from a
head-to-head pilot PK comparison trial (trial 005) evaluating
ND0612 and intra-duodenally delivered LD/CD gel suspension
requiring surgical intervention (DUODOPA®/DUOPATM) will also be
presented by Liat Adar, PhD, Director Clinical Pharmacology and
Personalized Medicine at NeuroDerm, in an abstract titled,
“Pharmacokinetic profile of continuous levodopa/carbidopa delivery
when administered subcutaneously (ND0612) versus duodenal
infusion,” (Abstract 1337). This abstract will also be presented in
the poster session on Thursday, June 8, from 1:15 p.m. to 2:45 p.m.
PT. NeuroDerm reported topline results from this study in
June 2016, with topline results demonstrating comparable
bioavailability to DUODOPA®.
Additionally, Cecile Durach, Medical Director of
Europe at NeuroDerm will present first-in-man clinical results for
ND0701, the company’s continuous apomorphine product. The abstract,
titled, “ND0701: A new concentrated formulation of Apomorphine for
continuous subcutaneous administration – human PK data” (Abstract
1391) will be presented on Thursday, June 8 from 1:15 p.m. to 2:45
p.m. PT.
The following abstracts will also be presented
during the poster session on Thursday, June 8 from 1:15 p.m. to
2:45 p.m. PT:
- “Patient perspectives using the ND0612 mini-pump” (Abstract
1384)
- “ND0612 (levodopa/carbidopa for subcutaneous infusion) achieves
stable levodopa plasma levels when administered in low and high
doses in patients with PD” (Abstract 1386)
- “Identification of the optimal carbidopa concentration in
subcutaneously administered ND0612” (Abstract 1393)
About
NeuroDerm
NeuroDerm is a clinical-stage pharmaceutical company developing
drug-device combinations for central nervous system (CNS) disorders
that are designed to overcome major deficiencies of current
treatments and achieve enhanced clinical efficacy through
continuous, controlled administration. NeuroDerm has three product
candidates in different stages of development that offer a solution
for almost every Parkinson’s disease patient from the moderate to
the very severe stage of the disease. NeuroDerm has developed a
line of levodopa and carbidopa (LD/CD) product candidates
administered through small belt pumps that deliver a continuous,
controlled dose of LD/CD. The LD/CD product candidates are ND0612L
and ND0612H, which are used for treatment of moderate and advanced
Parkinson’s disease patients, respectively, and which are delivered
subcutaneously. In addition, NeuroDerm is developing ND0701, a
novel subcutaneously delivered apomorphine formulation for patients
who suffer from moderate to severe Parkinson’s disease and who do
not respond well to LD/CD. NeuroDerm is headquartered in the
Weizmann Science Park in Rehovot, Israel.
Forward-Looking StatementsThis
press release contains forward-looking statements, within the
meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended that involve risks and uncertainties. Such
forward-looking statements may include projections regarding our
future performance and may be identified by words like
"anticipate," "assume," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict,"
"project," "future," "will," "seek" and similar terms or phrases.
The forward-looking statements contained in this press release are
based on management's current expectations and projections about
future events. There are important factors that could cause our
actual results, levels of activity, performance or achievements to
differ materially from the results, levels of activity, performance
or achievements expressed or implied by the forward-looking
statements. In particular, you should consider the risks provided
under "Risk Factors" in our annual report on Form 20-F for the year
ended December 31, 2016 filed with the Securities and Exchange
Commission. Any forward-looking statement made by us in this press
release speaks only as of the date hereof. Factors or events that
could cause our actual results to differ may emerge from time to
time, and it is not possible for us to predict all of them. We
undertake no obligation to publicly update any forward-looking
statements, whether as a result of new information, future
developments or otherwise.
NeuroDerm Contact:
Oded S. Lieberman, PhD, CEO
oded@neuroderm.com
Tel.: +972-8-946 2729
Cell: +1-617-517 6077
U.S. Investor Contact:
David Carey
Lazar Partners Ltd.
dcarey@lazarpartners.com
+212-867-1768
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