-ND0612H achieved a complete reduction of
OFF-time to zero in 42% of patients treated for 24 hours -
NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical
company developing drug-device combinations for central nervous
system (CNS) disorders, today announced final data from trial 006.
Sheila Oren, MD, MBA, Chief Medical Officer
at NeuroDerm will present the final 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 poster session
on Wednesday, June 7, from 1:15 p.m. to 2:45 p.m. (P.T.)
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.
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.
“The significant increase in Good ON time
coupled with a significant reduction in OFF time, including a
complete resolution of OFF time to zero in 42% of patients in the
first of our two regimens, demonstrates the substantial potential
of 24-hour administration of ND0612H,” said Oded S. Lieberman,
PhD, CEO of NeuroDerm. “The results of this study offer
additional evidence that this innovative therapy can transform the
care and outcome for patients with advanced Parkinson’s disease,
and suggest that ND0612 can provide significant patient benefit
without the surgical risks associated with deep brain stimulation
and LD/CD intestinal gel.”
Trial 006 Design Trial 006 was
a 28-day multicenter, international (U.S., EU and Israel),
parallel-group, blinded rater, randomized phase II study that
investigated the efficacy, safety, tolerability and
pharmacokinetics of two dosing regimens (R1 and R2) of ND0612H and
compared them to the baseline of standard optimized oral
therapy:
- R1: 24-hour administration of ND0612H (720/90mg LD/CD) at a
high day rate for 18 hours and a low night rate for 6 hours.
- R2: 14-hour administration of ND0612H during the waking hours
(538/68mg LD/CD) complemented by a morning dose of 150/15mg oral
LD/CD.
All patients could add oral LD/CD therapy at any
time as needed. The trial enrolled 38 patients with advanced
Parkinson’s disease.
Tamar Rachmilewitz MD, Medical Director
at NeuroDerm will present additional baseline patient
characteristic 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.
Trial 006 EndpointsThe primary
endpoint of this study was to assess the change from baseline to
day 28 in daily OFF-time (normalized to 16 waking hours) as
assessed by a blinded rater. A key secondary endpoint was to
assess the percentage of subjects who were “ON”
by 8:00am and 9:00am. Additional secondary endpoints
were also evaluated as well as safety and tolerability.
Trial 006 Study Efficacy and Safety
Results Five subjects did not complete the study. Reasons
for discontinuation were: adverse events (n = 2), lack of efficacy
(n = 2), and withdrawal of consent (n = 1).
Primary endpoint (OFF-time) and key secondary
endpoint (“ON” by 8:00am and 9:00am) achieved in R1:The primary
endpoint was met in R1. The OFF-time was reduced by 2.8 hours (p =
0.004), from 5.6 hours at baseline. There was a smaller,
non-statistically significant reduction of 1.3 hours in OFF-time in
R2.
In R1, the proportion of patients who achieved
the first “ON” by 8:00am (as reported by the patient)
increased from 11% at baseline to 50% by day 28 (p = 0.02), and,
by 9:00am, from 32% at baseline to 75% (p = 0.007).
Good ON (secondary endpoint):Good ON
(defined as no or mild dyskinesia, as assessed by the blinded
rater) increased in R1 by 3.7 hours (p < 0.001), from 9.2 hours.
Although the R2 regimen was not designed to provide optimal ND0612H
dosing, significant improvements in Good ON were also observed in
this cohort, increasing by 2.8 hours (p = 0.003), from 8.5
hours.
Complete reduction of OFF-time (post-hoc
analysis):In R1, 42% of patients had a complete reduction in
OFF-time to zero hours (11% in R2).
Troublesome Dyskinesia (post hoc
analysis):Troublesome dyskinesia (defined as “ON” with moderate or
severe dyskinesia as assessed by the blinded rater) decreased by
3.5 hours (p = 0.011), from 5.1 hours at baseline, in the subgroup
of all patients who had at least 1 hour of troublesome dyskinesia
at baseline (n = 14, R1 and R2 combined).
Reduction in Unified Parkinson’s Disease Rating
Scale (UPDRS) III (post-hoc analysis):UPDRS III score
at 8:00am decreased in R1 by 17.1 points, from 37.4 at
baseline to 20.3. Reductions in UPDRS scores in R1 were maintained
throughout the day and also observed at 12:00pm (6.9 points) and
4:00pm (6.5 points)
Safety and Tolerability:Both regimens were well
tolerated. Of the 38 subjects, four reported six serious adverse
events, including one subject with subcutaneous abscess and
orthostatic hypotension, and another with worsening PD symptoms.
These two patients did not complete the study. Additionally, one
subject fell and fractured his nose, and there was one case of
suspected panniculitis that was eventually ruled out. Infusion site
reactions (nodules, bruising, erythema and hemorrhage) were common,
yet generally well tolerated. These results corroborate the safety
and tolerability data obtained in previous studies and did not
raise new safety or tolerability concerns.
Additionally, the ND0612H infusion pump systems
were reliable with only few minor, correctable malfunctions
reported. No major inconvenience related to the wearing of the
device was reported for either day or night administration.
The following abstracts featuring NeuroDerm
clinical data will also be presented during the poster session on
Thursday, June 8 from 1:15 p.m. to 2:45 p.m.:
- “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)
- “ND0701: A new concentrated formulation of Apomorphine for
continuous subcutaneous administration – human PK data” (Abstract
1391)
- “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 2729
Cell: +1-617-517 6077
U.S. Investor Contact:David
CareyLazar Partners
Ltd.dcarey@lazarpartners.com +212-867-1768
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