Teva’s effort to reinvigorate its business with new product launches has suffered a setback after a drug for Tourette’s syndrome failed two registration trials.
The Israeli drugmaker said the drug – called deutetrabenazine – wasn’t able to improve on placebo when it came to controlling tics in children with moderate to severe Tourette’s in the phase 2/3 ARTISTS 1 and phase 3 ARTISTS 2 studies.
“The results of the trials are disappointing, especially as there is such an unmet need for this community of paediatric patients,” said Hafrun Fridriksdottir, head of global R&D at Teva, who said the company is now trying to “assess a path forward” for the programme.
It’s not the first drug in the VMAT2 inhibitor class to miss the mark in a Tourette’s trial, however. Neurocrine Biosciences’ Ingrezza (valbenazine) also did so in three trials before being abandoned at the end of 2018.
Tourette’s is a neurodevelopmental disorder that typically starts in childhood, with a peak in severity at around ten years, and can cause physical tics like blinking, sniffing and facial movements, as well as phonic tics such as vocal outbursts. The condition is estimated to affect one to ten in 1,000 children.
Deutetrabenazine is already approved as Austedo for the treatment of movement disorder chorea in patients with Huntington’s disease and for tardive dyskinesia – a side effect of antipsychotic drugs – but Teva has been keen to expand the drug into new settings.
It’s one of a clutch of new drugs – that also includes migraine prevention therapy Ajovy (fremanezumab) – that Teva needs to perform well and help it recover from the double whammy of a weak market for its generic drugs and declining sales of former cash cow Copaxone (glatiramer acetate) for multiple sclerosis.
Austedo’s growth has been encouraging so far, with sales of $412m last year, including a 68% increase to $136m in the last three months of the year on higher volumes. Full-year growth was higher at more than 100%.
Teva said before the Tourette’s disappointment that it was expecting the product to reach $650m in 2020, and that forecast is likely still current given the anticipated timeline for review of deutetrabenazine in the new indication if the trials had been positive.
Deutetrabenazine was acquired by Teva when it bought Auspex Pharma for $3.5bn in March 2015.
With the drug likely now out of the running as a treatment for Tourette’s, the pipeline of potential new clinical-stage therapies has taken a big hit.
There are a few other candidates in development however, including Lundbeck’s mid-stage drug ABX-1431, an MGLL inhibitor acquired along with Abide Therapeutics last year, Therapix’ tetrahydrocannabidiol-based THX-110 and Otsuka’s well-established antipsychotic drug Abilify (aripiprazole), which is in a trial with data due next year.