Results from Teva Pharmaceutical Industries have revealed that deutetrabenazine did not meet the primary endpoint in Phase II/III ARTISTS 1 and Phase III ARTISTS 2 studies involving pediatric patients with moderate to severe Tourette syndrome.
Deutetrabenazine, also called Austedo, is an inhibitor of vesicular monoamine transporter 2 (VMAT2). It is approved by the US Food and Drug Administration to treat tardive dyskinesia in adults, and Huntington’s disease-related chorea.
The ARTISTS 1 trial assessed the safety, tolerability and efficacy of the drug over 12 weeks in 119 paediatric Tourette syndrome patients aged six to 16.
Meanwhile, ARTISTS 2 involved 158 paediatric patients of the same age group. This trial was designed for eight weeks of dosing.
The primary endpoint of both studies was the change in the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) from baseline to week eight.
Deutetrabenazine missed the primary endpoint when it failed to demonstrate a decrease in motor and phonic tics compared to placebo.
The most commonly reported adverse events in the studies were headache, somnolence and fatigue. Investigators did not report any new safety signals.
Teva Global R&D executive vice-president Dr Hafrun Fridriksdottir said: “The results of the trials are disappointing, especially as there is such an unmet need for this community of paediatric patients.
“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.”
Teva conducted The ARTISTS 1 and ARTISTS 2 trials in alliance with Nuvelution Pharma.
In July last year, the company reported positive results from the exploratory endpoint analysis of the Phase IIIb FOCUS trial of fremanezumab as a preventive therapy for migraine in adults.