TEL AVIV, Israel I February 19, 2020 I Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Phase 2/3 ARTISTS 1 and Phase 3 ARTISTS 2 trials designed to evaluate deutetrabenazine compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome failed to meet the primary endpoint of reduction in motor and phonic tics as assessed by the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS).
“The results of the trials are disappointing, especially as there is such an unmet need for this community of pediatric patients”
In the data received this week, the most commonly reported adverse event in the ARTISTS 1 and ARTISTS 2 studies were headache, somnolence and fatigue. In this population, no new safety signals were identified that were inconsistent with the known safety profile of deutetrabenazine.
“The results of the trials are disappointing, especially as there is such an unmet need for this community of pediatric patients,” said Dr. Hafrun Fridriksdottir, Executive Vice President, Global R&D, at Teva. “As we assess a path forward, Teva is especially grateful to the investigators, patients and families who contributed to these studies for such an important patient population.”
The studies were conducted in partnership between Teva and Nuvelution Pharma, Inc.
Deutetrabenazine was approved by the FDA as AUSTEDO® (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease in April 2017 and for tardive dyskinesia in adults in August 2017.
About ARTISTS 1
The ARTISTS 1 study was a multicenter, randomized, double-blind, placebo-controlled, Phase 2/3 study to evaluate the safety, tolerability and efficacy of deutetrabenazine in 119 pediatric patients (6-16 years) with moderate to severe Tourette Syndrome. Patients received either deutetrabenazine or placebo using a 1:1 randomization over 12 weeks of dosing. The primary endpoint was the change in the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) from baseline to week 12 between placebo and active treatment groups.
About ARTISTS 2
The ARTISTS 2 study was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the safety, tolerability and efficacy of deutetrabenazine in 158 pediatric patients (6-16 years) with moderate to severe Tourette Syndrome. Patients received either deutetrabenazine (low dose or high dose) or placebo using a 1:1:1 randomization over eight weeks of dosing. The primary endpoint was the change in the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) from baseline to week eight between placebo and active treatment groups.
About Tourette Syndrome
Tourette Syndrome is a neurodevelopmental disorder with onset before age 18 years, characterized by motor and phonic tics that persist for greater than one year. Symptoms of Tourette Syndrome typically occur first in early childhood, with peak severity around the age of 10 years. Most individuals with Tourette Syndrome experience improvement of symptoms in late adolescence and into adulthood.
About AUSTEDO® (deutetrabenazine)
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established.
Indications and Usage
AUSTEDO® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
SOURCE: Teva Pharmaceutical Industries
Post Views: 19
TEL AVIV, Israel I February 19, 2020 I Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Phase 2/3 ARTISTS 1 and Phase 3 ARTISTS 2 trials designed to evaluate deutetrabenazine compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome failed to meet the primary endpoint of reduction in motor and phonic tics as assessed by the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS).
“The results of the trials are disappointing, especially as there is such an unmet need for this community of pediatric patients”
In the data received this week, the most commonly reported adverse event in the ARTISTS 1 and ARTISTS 2 studies were headache, somnolence and fatigue. In this population, no new safety signals were identified that were inconsistent with the known safety profile of deutetrabenazine.
“The results of the trials are disappointing, especially as there is such an unmet need for this community of pediatric patients,” said Dr. Hafrun Fridriksdottir, Executive Vice President, Global R&D, at Teva. “As we assess a path forward, Teva is especially grateful to the investigators, patients and families who contributed to these studies for such an important patient population.”
The studies were conducted in partnership between Teva and Nuvelution Pharma, Inc.
Deutetrabenazine was approved by the FDA as AUSTEDO® (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease in April 2017 and for tardive dyskinesia in adults in August 2017.
About ARTISTS 1
The ARTISTS 1 study was a multicenter, randomized, double-blind, placebo-controlled, Phase 2/3 study to evaluate the safety, tolerability and efficacy of deutetrabenazine in 119 pediatric patients (6-16 years) with moderate to severe Tourette Syndrome. Patients received either deutetrabenazine or placebo using a 1:1 randomization over 12 weeks of dosing. The primary endpoint was the change in the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) from baseline to week 12 between placebo and active treatment groups.
About ARTISTS 2
The ARTISTS 2 study was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the safety, tolerability and efficacy of deutetrabenazine in 158 pediatric patients (6-16 years) with moderate to severe Tourette Syndrome. Patients received either deutetrabenazine (low dose or high dose) or placebo using a 1:1:1 randomization over eight weeks of dosing. The primary endpoint was the change in the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) from baseline to week eight between placebo and active treatment groups.
About Tourette Syndrome
Tourette Syndrome is a neurodevelopmental disorder with onset before age 18 years, characterized by motor and phonic tics that persist for greater than one year. Symptoms of Tourette Syndrome typically occur first in early childhood, with peak severity around the age of 10 years. Most individuals with Tourette Syndrome experience improvement of symptoms in late adolescence and into adulthood.
About AUSTEDO® (deutetrabenazine)
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established.
Indications and Usage
AUSTEDO® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
SOURCE: Teva Pharmaceutical Industries
Post Views: 19
