Currently, there are no approved therapies in the U.S. for tardive
dyskinesia, representing significant unmet need
ARM-TD study meets primary endpoint; results show SD-809 reduces
abnormal involuntary movement in patients with tardive dyskinesia;
favorable safety and tolerability also demonstrated
Complements Teva’s growing CNS franchise in movement disorders and
neurodegenerative conditions
JERUSALEM--(BUSINESS WIRE)--Jun. 16, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced positive top-line results from the pivotal clinical study Aim
to Reduce Movements
in Tardive Dyskinesia
(ARM-TD) designed to evaluate the efficacy of SD-809 (deutetrabenazine)
in the treatment of moderate to severe tardive dyskinesia. Top-line data
showed that the study met its primary endpoint and demonstrated a
positive trend in all secondary endpoints. Importantly, the study also
showed a favorable safety and tolerability profile, including low rates
of depression, somnolence, insomnia and akathisia.
The primary endpoint of ARM-TD was the change in the Abnormal
Involuntary Movement Scale (AIMS) from baseline to end of therapy,
assessed by blinded centralized video rating. The study results show
patients taking SD-809 achieved an improvement of 3.0 points on the AIMS
score from baseline to end of therapy compared to 1.6 points in placebo
(p = 0.0188) for a clinically meaningful effect. Study results also
demonstrated a favorable safety and tolerability profile of SD-809.
Fewer patients taking SD-809 than placebo experienced serious adverse
events (SAEs) Three patients discontinued from the study for adverse
events (1 in SD-809 group vs. 2 in placebo group). For all other side
effects reported in the study, rates in the SD-809 group were similar or
lower than the placebo group. Further analysis of the additional data
from the study is ongoing and details will be shared at future medical
meetings and through peer-reviewed publication.
Tardive dyskinesia, a condition for which there are no approved
therapies in the United States, is a hyperkinetic movement disorder
characterized by repetitive and uncontrollable movements of the tongue,
lips, face, trunk and extremities. The often debilitating disorder
affects about 500,000 people in the United States and is a result of
treatment with widely used medications for psychiatric conditions such
as schizophrenia and bipolar disease, and certain drugs used for
treating various gastrointestinal disorders.
“SD-809 is an exciting addition to Teva’s CNS portfolio and has the
potential to offer a meaningful and much needed therapeutic option to
patients suffering from involuntary movements related to a number of
disorders. Currently our development program includes studies in tardive
dyskinesia, Huntington’s disease and Tourette syndrome,” said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific
Officer at Teva. “We are committed to developing innovative medicines in
this therapeutic area and we are making great progress in bringing a
potential new treatment to the patients and their families who can
benefit most.”
SD-809 became part of Teva’s central nervous system (CNS) product
portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.
Teva has numerous development programs in CNS focused on
neurodegeneration and movement disorders which include Huntington’s
disease, Tourette syndrome, Parkinson’s disease, multiple sclerosis, and
tardive dyskinesia. In addition to SD-809, Teva is developing
pridopidine, laquinimod and other undisclosed assets in the
neurodegenerative category.
“We are extremely pleased with these data of SD-809 in another condition
with people in great need,” said Pratik Shah, Ph.D., president and CEO,
Auspex Pharmaceuticals. “We believe strongly in the potential of SD-809
to become a treatment of choice for tardive dyskinesia and other
seriously debilitating movement disorders.”
“These clear and clinically meaningful efficacy and safety results for
SD-809 in a rigorously performed global multicenter clinical trial for
tardive dyskinesia are very encouraging,” said Hubert Fernandez, M.D.,
Professor of Neurology at the Center for Neurological Restoration at the
Cleveland Clinic and Principal Investigator of the SD-809 ARM-TD
clinical study. “There is a serious and growing medical need as tardive
dyskinesia is one of the most debilitating and often irreversible side
effects of dopamine receptor blocking agents, which are increasingly
being used in the United States for various psychiatric disorders and
gastrointestinal conditions. With no approved treatments of this serious
condition currently available, the need for a therapeutic solution is
urgent and overdue.”
About The ARM-TD Study
The ARM-TD study was a 1:1 randomized, double-blind, placebo-controlled,
parallel-group study of 117 patients globally (104 patients completed
the study) with moderate to severe tardive dyskinesia. Enrolled patients
received either SD-809 or placebo, which was titrated to optimal dosage
over the course of six weeks, and then administered at that dose for
another six weeks for a total treatment of 12 weeks. For further details
on the ARM-TD study, visit https://clinicaltrials.gov/ct2/show/study/NCT02195700.
The objectives of the study were to evaluate the efficacy of SD-809 in
reducing the severity of abnormal involuntary movements associated with
tardive dyskinesia and to evaluate the safety and tolerability of
titration and maintenance therapy with SD-809 in subjects with
drug-induced tardive dyskinesia.
About SD-809
SD-809 (deutetrabenazine) is an investigational, oral, small molecule
inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is
designed to regulate the levels of a specific neurotransmitter,
dopamine, in the brain. SD-809 is being developed for the treatment of
chorea associated with Huntington’s disease, a neurodegenerative
movement disorder that impacts cognition, behavior, and movements. Teva
is investigating the broad potential of SD-809 for treating additional
movements disorders such as tardive dyskinesia and tics associated with
Tourette syndrome.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 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 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
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Source: Teva Pharmaceutical Industries Ltd.
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