NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical
company developing drug-device combinations for central nervous
system (CNS) disorders, today announced that it will present six
posters related to its clinical pipeline in a poster session today
from 1:15 p.m. to 2:45 p.m. PT at the 21st International
Congress of Parkinson’s Disease and Movement Disorders. The
Congress is taking place June 4-8,
2017 in Vancouver, B.C.
Tami Rachmilewitz, MD, Medical Director
at NeuroDerm will present complete demographic 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).
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. 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. Final safety and efficacy results
from this trial were presented Monday in a late-breaking poster
session (Abstract LBA41).
Baseline characteristics of the 38 patients
enrolled in trial 006 were:
- Mean age of 63.5 years
- 68.4% male
- Majority of patients with a modified Hoehn and Yahr Stage of 2
(bilateral involvement without balance impairment, 63.2%) or 2.5
(mild bilateral disease with recover on pull test, 23.7%)
- Mean of 11.5 years since diagnosis of Parkinson’s disease, 5.6
years since onset of motor fluctuations and 3.7 years since the
onset of dyskinesia
- Mean daily OFF-time of 5.3 hours and daily time with moderate
or severe dyskinesia of 1.9 hours
- Mean Unified Parkinson’s Disease Rating Scale (UPDRS) III of
37.3
- Mean LD dose of 1094.9 mg and mean frequency of LD dosing of
6.9 times a day
Baseline characteristics were similar between
the R1 (24-hour administration of ND0612, n= 19) and R2 (14-hour
administration of ND0612, n = 19) dose cohorts.
“Patients participating in trial 006 had
baseline characteristics typical of advanced Parkinson’s disease
that was already negatively impacting their motor function,”
said Oded S. Lieberman, PhD, CEO of NeuroDerm. “That the
trial met its primary, key secondary and additional secondary
endpoints even in patients with advanced disease is highly
encouraging and supports the growing body of data that suggests
ND0612 may have potential as a transformative therapy for
Parkinson’s disease.”
During today’s poster session, Cecile Durlach,
Medical Director Europe at NeuroDerm will present final results
from a Phase 1 pharmacokinetic (PK) study (trial 101) of ND0701 in
a poster titled “ND0701: A new concentrated formulation of
Apomorphine for continuous subcutaneous administration – human PK
data” (Abstract 1391). NeuroDerm reported top-line results from
this trial in December 2016.
Trial 101 DesignTrial 101 was a Phase-1,
randomized, open-label, two-sequence, partial cross-over, pilot
study comparing the PK of ND0701 with that of commercial
apomorphine (APO-go®) in 18 healthy volunteers. The primary
objective was to evaluate the PK and relative bioavailability of
ND0701 subcutaneous (SC) infusion and commercial apomorphine.
The secondary objective was to assess the safety and
tolerability of ND0701 and commercial apomorphine administered by
SC infusion over 12 hours.
All subjects received an initial 1 mg/h dose of
ND0701 on Day 1, followed by 2 mg/h ND0701 and 2 mg/h commercial
apomorphine on subsequent dosing days in a randomized, partial
cross-over manner, based on the recommendation of titrating
commercial apomorphine for better tolerability. Subjects were
randomized into 2 sequences to receive 3 consecutive doses.
PK blood samples were collected pre-dose and at
predetermined time points up to 24 hours after start of infusion
for determination of apomorphine plasma concentrations. Safety and
tolerability assessments were done at specified time points until
completion of the follow-up visit. Evaluation of safety parameters
included analysis of adverse events (AEs), laboratory variables,
vital signs, electrocardiograms (ECGs), infusion site reactions,
and physical examination findings.
Trial 101 Final ResultsAll 18 subjects were
included in the safety and PK populations. PK analysis datasets
were defined for formal statistical analysis and comprised 16
subjects, as two subjects withdrew from the study.
PK ResultsFollowing 12 hours of SC infusion with the three
regimens, the bioavailability of apomorphine from ND0701 (24.00 mg
[2 mg/h]) was comparable to that of commercial apomorphine (24.28
mg [2 mg/h]). Statistical analysis confirmed that peak and total
exposures were similar for ND0701 and commercial apomorphine, as
were peak and total exposures for dose-corrected parameters of the
two dosing regimens of ND0701 (Cmax, AUC0-last’ and AUC0-inf’),
indicating close to dose-proportional increase.
Safety ResultsBoth ND0701 and commercial apomorphine appeared to
be well tolerated under the conditions of the study and no severe
or serious treatment-emergent AEs (TEAEs) were reported for any
subject. The lowest incidence was following ND0701 2 mg/h (50%).
TEAEs were reported in 64.7% of subjects receiving 2 mg/h of
commercial apomorphine. The incidence of TEAEs was highest
following the initial 1 mg/h dose of ND0701 (83.3%), which is
expected on the first day of titration.
ND0701 TEAEs were most frequently reported in
the gastrointestinal and nervous system disorders system organ
classes. The most frequently reported events within these
categories were nausea, vomiting, dizziness, and somnolence; the
lowest incidence was observed following ND0701 2 mg/h. The majority
of TEAEs were mild in severity, none were severe. Only one TEAE was
reported as local site reaction for a severe nodule (44 mm × 8 mm
in size) following 2 mg/h commercial apomorphine ApoGo infusion.
All post-dose physical examinations were normal, except for a
muscle spasm associated with a pre-dose AE. There were no
clinically significant findings in any vital signs, laboratory
assessments and ECGs.
Erythema, swelling, and pain were noted at
infusion sites for a few subjects across regimens, with no notable
difference in incidence or severity between the ND0701 2 mg/h sites
and the commercial apomorphine 2 mg/h sites; all incidents resolved
by the 28-day follow-up visit. Infusion site nodules were reported
more frequently and their incidence and severity were higher at
sites administered commercial apomorphine 2 mg/h (10 small, 1
medium, and 1 severe nodule) compared with sites administered
ND0701 2 mg/h (6 small nodules). More nodules were still evident at
the 28-day follow-up visit following administration of commercial
apomorphine 2 mg/h (n=4) compared with ND0701 2 mg/h (n=1).
“The results of trial 101 align with findings
from previous preclinical studies that demonstrated expected good
local safety and tolerability of ND0701 with comparable PK to
commercial apomorphine,” noted Dr. Lieberman. “These findings
support the continued development of ND0701, and we remain on track
to meet with EU regulatory authorities to discuss the ND0701
clinical development plan in the first half of 2017 and to initiate
a follow-on PK study by the end of the year.”
The following abstracts will also be presented
during the poster session today from 1:15 p.m. to 2:45 p.m. by Tami
Rachmilewitz, MD and Liat Adar, PhD, Director of Clinical
pharmacology:
- “Pharmacokinetic profile of continuous levodopa/carbidopa
delivery when administered subcutaneously (ND0612) versus duodenal
infusion” (Abstract 1337)
- “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
central nervous system (CNS) product candidates that are designed
to overcome major deficiencies of current treatments and achieve
enhanced clinical efficacy through continuous, controlled
administration. NeuroDerm’s main focus is in Parkinson's
disease, where it has three clinical stage product candidates in
development which offer a solution for almost every Parkinson’s
disease patient, from moderate to the very severe stage of the
disease. The primary product candidates are a line of
levodopa and carbidopa (LD/CD) products administered through small
belt pumps that deliver a continuous, controlled dose of
LD/CD. The LD/CD product candidates, ND0612L and ND0612H, are
aimed at the treatment of moderate and advanced Parkinson’s disease
patients, respectively, and are delivered subcutaneously. NeuroDerm
is also designing a patch pump for future use. 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,
CEOoded@neuroderm.com Tel.: +972-8-946 2729Cell: +1-617-517
6077
U.S. Investor Contact:David CareyLazar Partners
Ltd.dcarey@lazarpartners.com+212-867-1768
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