Teva draws blank in phase 3 Tourette Syndrome trial
Teva’s late stage trials of a potential drug for Tourette Syndrome have drawn a blank, just when the troubled pharma needs to freshen up its portfolio.
The Israel-based company is still feeling the effects of its Copaxone (glatiramer) multiple sclerosis drug going off-patent, and an ill-fated merger with Allergan’s generics division that left it saddled with huge debts.
Under the leadership of CEO Kare Schultz, Teva is looking to a pipeline of neurologic drugs to revive its fortunes, but things don’t seem to have worked out with deutetrabenazine in a new Tourette’s indication.
Teva said the phase 2/3 ARTISTS 1 and phase 3 ARTISTS 2 true programme failed to meet their goals of primary endpoint of reduction of motor and phonic tics, as measured by a standard scale.
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, with no new safety signals.
The drug is a vesicular monoamine transporter 2 (VMAT2) inhibitor, already FDA approved for involuntary movements associated with Huntington’s disease and tardive dyskinesia for more than two years, under the brand name Austedo.
ARTISTS 1 was a placebo-controlled, phase 2/3 study deutetrabenazine in 119 children aged 6-16 years with moderate to severe Tourette Syndrome.
ARTISTS 2 was essentially the same trial repeated, with 158 children from the same age group and same disease severity.
Teva has not confirmed its plans for deutetrabenazine in this use, but its assessment in a public statement was downbeat.
Dr Hafrun Fridriksdottir, executive vice president of global R&D at Teva, 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.”
The studies were conducted in partnership between Teva and Nuvelution Pharma, Inc.
Tourette Syndrome is a neurodevelopmental disorder with onset before the age of 18, characterised 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.
Most individuals with Tourette Syndrome experience improvement of symptoms in late adolescence and into adulthood.
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