Results of NeuroDerm’s ND0612H Phase II Trial Presented in Oral Session at the 3rd Congress of the European Academy of Neur...
June 27 2017 - 7:00AM
-Complete reduction of OFF-time to zero in 42% of
patients treated for 24 hours; statistically significant and
clinically meaningful reduction in OFF-time and increase in the
portion of patients ON by 8:00am-
NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical
company developing drug-device combinations for central nervous
system (CNS) disorders, today announced that Werner Poewe,
Professor of Neurology and Director of the Department of Neurology
at Innsbruck Medical University, presented final results from trial
006 at the 3rd Congress of the European Academy of Neurology. The
presentation, titled “Safety, efficacy and tolerability of
continuous SC LD/CD (ND0612H) infusion in PD patients with motor
fluctuations,” (Presentation LB_02) was delivered at 6:00p.m. CEST
during the Movement Disorder I oral session. The Congress is taking
place June 24-27, 2017 in Amsterdam, Netherlands.
The final trial results were previously presented June 5, 2017 in a
poster session at the 21st International Congress of Parkinson’s
Disease and Movement Disorders.
“The significant improvements in Good ON time
and off time reported in this trial are encouraging to us and to
members of the Parkinson disease patient and physician
communities,” said Oded S. Lieberman, PhD, CEO of
NeuroDerm. “As announced earlier this month, the European
Medicines Agency has accepted the design of our Phase III iNDiGO
efficacy trial, keeping us on track to achieve our goal of
submitting European regulatory applications for ND0612 by the end
of 2018. We are pleased to have the opportunity to share the
results of trial 006 today with so many European physicians.”
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, NeuroDerm's high dose continuous,
subcutaneously delivered levodopa/carbidopa (LD/CD) liquid
formulation, 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.
The trial enrolled 38 patients with advanced
Parkinson’s disease. The 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
during an 8 hour in-clinic observation starting at the time of the
first LD/CD dose (approximately 8:00AM). 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. All
patients could add oral LD/CD therapy at any time as
needed.
Key findings from trial 006 include:
- Attainment of the primary endpoint in patients receiving the R1
regimen (mean reduction of 2.8 hours, p=0.004)
- Complete reduction of off time to zero hours in 42% of patients
receiving the R1 regimen
- Proportion of R1 subjects with full ON was significantly
increased at 8:00am and 9:00am (p=0.02 and p=0.007,
respectively)
- Good ON time (defined as ON with no or mild dyskinesia, as
assessed by the blinded rater) significantly increased in both R1
subjects (p < 0.001) and R2 (p=0.003).
- Both the R1 and R2 regimens were well tolerated. The most
frequent adverse events were mild-moderate infusion-site reactions:
nodules (47%), bruising (18%) and erythema (18%).
About NeuroDermNeuroDerm 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.comTel.: +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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