Pridopidine Demonstrates Slowing of Progression of Huntington
Disease in PRIDE-HD Study as Measured by Total Functional Capacity
JERUSALEM--(BUSINESS WIRE)--Sep. 19, 2016--
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announces
top-line results from the exploratory Phase 2 PRIDE-HD study. This was a
52-week, dose-ranging trial of pridopidine twice daily versus placebo,
in the treatment of Huntington disease (HD). The study was directed at
measuring improvement in motor function and the effect on HD progression.
An unusually high placebo effect, extending beyond that expected from
previous studies, limited the ability to determine treatment effects on
assessments of HD motor scores. Evidence of symptomatic impact, however,
was seen in the early stage HD patient sub-population, with improvement
in Total Motor Score (TMS) and dystonia observed at 26 and 52 weeks in
this patient sub-set (stage 1 HD) at specific doses.
The discovery of pridopidine's previously unknown mode of action as a
potent agonist of the Sigma 1 Receptor (S1R) resulted in a change in
PRIDE-HD study design, from a 26-week study focused on symptoms, to a
52-week study focused on exploring pridopidine’s potential impact on
disease progression, as measured by Total Functional Capacity (TFC). TFC
is the most widely accepted and validated tool for assessing disease
stage in HD. It has been used as the endpoint in more than 10 previous
clinical trials of drugs seeking to demonstrate an impact on HD
progression, none of which were successful.
This study showed a statistically significant impact on the endpoint of
disease progression at 52 weeks following treatment with pridopidine at
certain doses versus placebo, as measured by TFC. The effect of
pridopidine was further evident in a sub-population of patients with
early stage HD, an effect first observed at 26 weeks.
Improvements were seen for early stage HD patients in elements that make
up TFC, such as ability to undertake domestic chores, activities of
daily living and impact on ability to manage finances. Patients'
mobility and ability to move around (ambulation) may have contributed to
improved TFC scores, with multiple ambulation-related endpoints (such as
gait, walking, ability to get up from sitting and walk, and stair
climbing) demonstrating trends favoring pridopidine.
Safety and tolerability were consistent with the safety profile seen in
previous studies and compatible with continued development. No new
safety findings were reported.
These results were presented at the 9th European Huntington Disease
Network Plenary Meeting in The Hague on September 18, 2016. Full results
from PRIDE-HD will be submitted for publication in a scientific journal.
"I am encouraged by these results, which provide us with clear insights
into the approach to be taken in Phase 3 development", said Michael
Hayden, President of Teva Global R&D and Chief Scientific Officer. "My
obvious hope is that this will provide the HD community with a medicine
capable of slowing down the progression of this devastating disease."
"These study results are very important for the HD community and for the
continued development of pridopidine. Firstly, pridopidine’s safety
profile has been confirmed and extended. Secondly, we now have a clearer
idea of the dosages to study in Phase 3. Lastly, we have some of the
most encouraging evidence to date about an intervention which may slow
the inexorable functional decline of HD," said Karl Kieburtz, M.D.,
M.P.H., Director of the Clinical & Translational Science Institute at
the University of Rochester Medical Center.
"Slowing down the progression of this disease has proven to be
impossible until now. These findings give us a reason to believe we may
be finally making progress in slowing deterioration of disease," said
Spyros Papapetropoulos, Teva's Vice President of Clinical Development,
Neurodegenerative Diseases.
The results seen in this exploratory study will need to be confirmed in
a Phase 3 program that will be developed in collaboration with relevant
regulatory agencies.
Pridopidine is an investigational, oral small molecule being developed
for the treatment of HD that exerts its effect as an agonist of S1R. S1R
plays a key role in neuroprotection through increased production of
brain-derived neurotrophic factor (BDNF). Levels of BDNF are decreased
in HD and other neurodegenerative disorders including Parkinson's
disease, Alzheimer's disease and ALS.
About the PRIDE-HD Study
PRIDE-HD is a Phase 2, hypothesis-generating, dose-ranging, randomized,
parallel-group, double-blind, placebo-controlled study. The study was
directed towards measuring effects on HD progression and improvements in
motor function using pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg
twice daily versus placebo for the treatment in patients with HD.
PRIDE-HD enrolled 400 patients at 52 sites globally. Disease progression
outcomes were measured using the TFC scale. Patients were also assessed
using the Unified Huntington Disease Rating Scale Total Motor Score
(TMS). PRIDE-HD was conducted in collaboration with the European
Huntington's Disease Network and the Huntington Study Group.
About Huntington Disease
HD is a fatal neurodegenerative disease for which there is no known cure
or prevention. People who suffer from HD will likely have a variety of
steadily-worsening symptoms, including uncoordinated and uncontrolled
movements, cognition and memory deterioration and a range of behavioral
and psychological problems. HD symptoms typically start in middle age,
but the disease may also manifest itself in childhood and in old age.
Disease progression is characterized by a gradual decline in motor
control, cognition and mental stability, and generally results in death
within 15 to 25 years of clinical diagnosis. Current treatment is
limited to managing the symptoms of HD, as there are no treatments that
have been shown to alter the progression of HD. Studies estimate that HD
affects about 13 to 15 people per 100,000 in Caucasians, and for every
affected person there are approximately three to five people who may
carry the mutation but are not yet ill.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net
revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of realizing
such benefits); the fact that following the consummation of the Actavis
Generics acquisition, we are dependent to a much larger extent than
previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount of
debt incurred to finance the Actavis Generics acquisition; the fact that
for a period of time following the Actavis Generics acquisition, we will
have significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from investments in our pipeline of specialty
and other products; our ability to identify and successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; the extent to which any
manufacturing or quality control problems damage our reputation for
quality production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions as
well as credit risks; the effectiveness of our patents, confidentiality
agreements and other measures to protect the intellectual property
rights of our specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
governmental investigations into sales and marketing practices,
particularly for our specialty pharmaceutical products; adverse effects
of political or economic instability, major hostilities or acts of
terrorism on our significant worldwide operations; interruptions in our
supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
or breaches of our data security; competition for our specialty
pharmaceutical businesses from companies with greater resources and
capabilities; the impact of continuing consolidation of our distributors
and customers; decreased opportunities to obtain U.S. market exclusivity
for significant new generic products; potential liability in the U.S.,
Europe and other markets for sales of generic products prior to a final
resolution of outstanding patent litigation; our potential exposure to
product liability claims that are not covered by insurance; any failure
to recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare and
Medicaid reporting and payment obligations; significant impairment
charges relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting reliance
on access to the capital markets; potentially significant increases in
tax liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2015 and in our other filings with the U.S. Securities and Exchange
Commission (the "SEC"). Forward-looking statements speak only as of the
date on which they are made and we assume no obligation to update or
revise any forward-looking statements or other information, whether as a
result of new information, future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160919005508/en/
Source: Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin C. Mannix, (215) 591-8912
or
Ran
Meir, (215) 591-3033
Israel
Tomer Amitai, 972 (3) 926-7656
or
PR
Contacts:
Israel
Iris Beck Codner, 972 (3) 926-7687
or
United
States
Denise Bradley, (215) 591-8974
or
Nancy Leone,
(215) 284-0213