– Study initiation represents significant milestone for patients with
a disease with limited effective treatment options –
JERUSALEM--(BUSINESS WIRE)--Apr. 24, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today
enrollment of the first patient in The Pride-HD study, a phase II,
randomized, double-blind, placebo-controlled global study designed to
evaluate the impact of pridopidine, an investigational medication, on
motor impairment in patients with Huntington’s disease (HD).
“Huntington’s disease represents a significant unmet medical need as
there are currently no treatments that improve the motor movements that
are crucial for gait, balance and coordination –things that greatly
impact a patient,” said Professor G. Bernhard Landwehrmeyer, M.D., Ph.D,
FRCP, lead study investigator and professor of neurology, Ulm University
Hospital, Germany. “Based on previous observations using the compound,
we believe pridopidine holds promise for symptomatic relief with an
acceptable safety profile.”
“Existing treatments aren’t appropriate for some patients due to side
effects and the predominant effect on involuntary movements,” said Karl
Kieburtz, M.D., study investigator and director of the Clinical &
Translational Science Institute, University of Rochester Medical Center.
“Based on the preliminary clinical evidence to date, we believe
pridopidine has the potential to make a real difference in the lives of
HD patients and families.”
The start of patient enrollment in The Pride-HD Study represents the
latest milestone in Teva’s commitment to developing medicines to improve
the quality of life for patients suffering from devastating CNS
diseases, such as Huntington’s disease.
“People with HD are in urgent need of new treatments and we are
committed to investigating the potential benefit of pridopidine as
quickly as possible," said Michael Hayden, M.D., a leading expert in the
study of Huntington’s disease and President of Global R&D and Chief
Scientific Officer at Teva.
“Pridopidine has shown promising results in previous advanced-stage
clinical trials and merits additional study, as it has the potential to
have a significant effect on Total Motor Score (TMS) – the endpoint most
commonly used in the assessment of treatment efficacy in HD,” said Dr.
Ralf Reilmann, study investigator and founding director and C.E.O.,
George-Huntington-Institute, Münster, Germany.
ABOUT THE PRIDE-HD STUDY
The Pride-HD Study, a phase II, dose-finding, randomized,
parallel-group, double-blind, placebo-controlled study, that aims to
enroll approximately 400 patients at 30 sites across the globe and
evaluate the safety and efficacy of pridopidine 45 mg, 67.5 mg, 90 mg,
and 112.5 mg twice daily (bid) versus placebo for symptomatic treatment
in patients with HD.
The primary objective will be to assess the efficacy of pridopidine on
motor impairment after 26 weeks of treatment using the Unified
Huntington’s Disease Rating Scale (UHDRS) Total Motor Score (TMS). The
study will also examine the effect of treatment with pridopidine on the
Physical Performance Test (PPT), as well as the safety and tolerability
across the range of pridopidine doses in patients with HD during the 26
weeks of treatment.
Qualifying patients for The Pride-HD study must be 21 years of age or
older, with an onset of HD after age 18 and must have a diagnosis of HD
based on clinical features and the presence of ≥36
cytosine-adenosine-guanine (CAG) repeats in the HTT gene. More
information about the study can be found at http://clinicaltrials.gov/ct2/show/NCT02006472
or by calling 1-800-896-5855.
ABOUT PRIDOPIDINE
Pridopidine is an investigational, oral, small molecule being developed
for the symptomatic treatment of Huntington’s disease (HD). Teva intends
to design and complete new clinical studies of pridopidine to assess its
potential for symptomatic relief of HD. Earlier clinical studies of
pridopidine conducted in the U.S., EU and Canada in patients with HD
indicate a significant treatment effect on an important secondary
endpoint, Total Motor Score (TMS).
In previous studies, where doses up to 45 mg bid were tested,
pridopidine was well tolerated with an adverse event profile similar to
placebo, and treatment with pridopidine was not associated with
worsening of disease signs and symptoms.
ABOUT HUNTINGTON’S DISEASE
Huntington’s disease (HD) is a fatal neurodegenerative disease
characterized by uncoordinated and uncontrollable movements, cognitive
deterioration and behavioral and/or psychological problems. The classic
onset of HD symptoms typically occurs in middle age, but the disease
also manifests in children and the elderly. HD is the most common
genetic cause of abnormal involuntary writhing movements called chorea.
Disease progression is characterized by a gradual decline in motor
control, cognition and mental stability and generally results in death
within 15‐25 years of clinical diagnosis.
HD is a genetic disease, passed from parent to child through a gene
mutation. Each child of an HD parent has a 50-50 chance of inheriting
the HD gene. If a child does not inherit the HD gene, he or she will not
develop the disease and cannot pass it to subsequent generations. A
person who inherits the HD gene will sooner or later develop the
disease. According to the World Health Organization, Huntington’s
disease affects about five to seven people per 100,000 in Western
countries.
ABOUT TEVA
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical
company, committed to increasing access to high-quality healthcare by
developing, producing and marketing affordable generic drugs as well as
innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world's leading
generic drug maker, with a global product portfolio of more than 1,000
molecules and a direct presence in approximately 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 45,000 people around the world and reached $20.3 billion
in net revenues in 2013.
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Source: Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix, United States, 215-591-8912
Ran Meir,
United States, 215-591-3033
Tomer Amitai, Israel, (972 (3) 926-7656
or
PR:
Iris
Beck Codner, Israel, 972 (3) 926-7687
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States, 215-591-8974
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