Teva Announces Registration Trials of Deutetrabenazine in Pediatric Patients with Tourette Syndrome Did Not Meet the Primary Endpoint

Nachrichtenquelle: Business Wire (engl.)
19.02.2020, 22:05  |  255   |   |   

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).

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.

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