- Clinical Trial Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Two Dosing Regimens of ND0612
Compared With Oral Standard of Care Treatment in Patients With Advanced Parkinson’s Disease -
- Clinical and Pre-Clinical Data Investigating the Effect of Continuous Carbidopa Administration on Levodopa
Plasma Levels Also Selected for Presentation -
- Preclinical Data for ND0701, NeuroDerm’s Investigational Continuous Subcutaneous Apomorphine Formulation for
Advanced Parkinson’s Disease, Also Selected for Presentation -
REHOVOT, Israel, June 16, 2016 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (Nasdaq:NDRM), a clinical-stage pharmaceutical
company developing drugs for central nervous system (CNS) diseases, today announced that design of its ongoing Phase II clinical
trial of ND0612H for the treatment of Parkinson’s diseases (trial 006), as well as other clinical and pre-clinical data on the
effect of continuous carbidopa administration on levodopa plasma levels as well as pre-clinical data investigating ND0701, its new
apomorphine product candidate for the treatment of Parkinson’s disease, will be presented at the 20th International
Congress on Parkinson’s Disease and Movement Disorders taking place June 19 to June 23, 2016 in Berlin, Germany. ND0612H and
ND0701, NeuroDerm’s investigational candidates for the treatment of severe Parkinson’s disease (PD), are continuously administered
subcutaneous formulations of levodopa/carbidopa (LD/CD) and apomorphine.
Karl Kieburtz, MD, MPH, the Robert J. Joynt Professor in Neurology, Senior Associate Dean for Clinical Research
and Director of the Clinical & Translational Science Institute at the University of Rochester Medical Center, will present a poster
titled, “A randomized controlled clinical study to evaluate efficacy, safety and tolerability of SC L-dopa/carbidopa (ND0612H)
infusion regimens in fluctuating PD patients,” (Abstract 1971). The poster will be presented in the Parkinson’s disease:
Clinical trials, pharmacology and treatment session to be held 12:00 p.m. – 1:30 p.m. on June 23.
ND0612H’s first efficacy trial (trial 006), initiated in December 2015, is a multicenter, open-label,
rater-blind Phase II study that will enroll 36 Parkinson's disease patients who experience at least 2.5 hours of “off” time per day
and whose symptoms are not adequately controlled with oral medications. This trial is designed to investigate the safety,
tolerability and pharmacokinetics of two regimens of ND0612H (continuous subcutaneous infusion over 24 or 14 hours) as well as
their effect on “off” time in comparison to standard LD/CD therapy (change from baseline). Data presented will include the
design and objectives of this study.
Oron Yacoby-Zeevi, PhD, DVM, VP R&D, will participate in a guided tour of a poster titled, “Continuous
subcutaneous delivery of solubilized carbidopa improves the pharmacokinetic profile of levodopa” (Abstract 1973). The poster
will also be presented in the session titled, “Parkinson’s disease: Clinical trials, pharmacology and treatment,” to be held from
12:00 p.m. to 1:30 p.m. on June 23. Presented data will include results from a series of pharmacokinetic studies in pigs,
mice, and humans to characterize continuous subcutaneous carbidopa delivery co-administered with oral LD/CD on LD pharmacokinetics
compared with oral LD/CD.
Dr. Yacoby-Zeevi will also present data from preclinical studies of ND0701 in a poster titled, “ND0701: A novel
safe concentrated apomorphine formulation for continuous subcutaneous administration via a patch pump” (Abstract 1977).
ND0701 is a drug candidate based on a novel, proprietary apomorphine formulation that was developed to have significantly
better local tolerability and be approximately five times more concentrated than the current apomorphine-HCL based commercial
products. ND0701 is designed to be administered through a small patch-pump and be a therapy alternative for advanced PD
patients who suffer from high motor fluctuations and who do not respond well to LD/CD. The poster will be presented in the
Parkinson’s disease: Clinical trials, pharmacology and treatment session to be held 12:00 p.m. – 1:30 p.m. on June 23.
Presented data will include local site reactions following subcutaneous administration of ND0701 or apomorphine-HCL during a
24-hour period, and the apomorphine plasma concentrations reached in steady-state.
About Levodopa
Oral administration of LD/CD is regarded as the "gold standard" treatment for patients suffering from Parkinson's disease.
Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels. Virtually
all patients diagnosed with Parkinson's disease will require levodopa at some point over the course of their treatment for the
disease, and 70% to 80% of patients receive the drug at any given point in time. However, levodopa is limited by its short
half-life. Approximately three to four hours after a single dose, almost none of the drug remains in the plasma. In
addition, levodopa suffers from low absorption when administered orally, with only about 30% of the levodopa entering the blood
stream.
ND0612H and ND0612L
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous,
subcutaneous delivery of LD/CD solution. Previously completed Phase II trials demonstrated that ND0612L maintained steady,
therapeutic levodopa plasma concentrations that were associated with major changes in several clinical parameters including "off
time" reductions when added to optimized oral standard of care. ND0612H, intended for severe Parkinson's disease patients,
was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to
current treatments requiring surgery such as deep brain stimulation and LD/CD Intestinal Gel.
About Parkinson's disease
Parkinson's disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a
debilitating decrease in the patient's motor and non-motor functions. Its symptoms, such as trembling in the extremities and
face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient's quality of
life. Levodopa is the most effective treatment for Parkinson’s disease. However, chronic oral levodopa treatment is
associated with fluctuations in motor response as result of which, despite the benefits of the drug, patients can experience
periods of impaired motor and non-motor functions, also referred to as "off" time. In addition, mainly as a result of
excessive/intermittent oral doses of levodopa aimed at treating the "off" time, some patients experience involuntary movements, or
dyskinesia. The "off" time and dyskinesia affect the majority of levodopa-treated Parkinson's disease patients and can
interfere with day-to-day functions, causing patients to become severely disabled. Current evidence suggests that
intermittent dosing with standard oral formulations of levodopa contributes to the development of these motor complications.
By contrast, it has been shown that continuous administration of levodopa can effectively treat motor fluctuations in
Parkinson's disease patients without increasing troublesome dyskinesia; however, a convenient route for continuous administration
has not been introduced to date.
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. The company has three product candidates in different stages of development which offer a solution for almost
every Parkinson’s disease patient from the moderate to the very severe stage of the disease. The company 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 Statements
This 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, 2015 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
U.S. Media Contact:
Erich Sandoval
Lazar Partners Ltd.
esandoval@lazarpartners.com
+917-497-2867
