Teva Pharmaceutical Industries’ US affiliate Teva Pharmaceuticals has reported findings from the ARC-HD clinical trial of Austedo (deutetrabenazine) tablets to treat patients with chorea linked to Huntington’s disease (HD).
The multicentre, three-year, single-arm, open-label, two-cohort, extension trial assessed the safety and tolerability of long-term use of Austedo in these patients.
Teva carried out the trial in collaboration with the Huntington Study Group (HSG).
According to the findings, Austedo demonstrated to have a safety and tolerability profile in line with the First-HD trial.
First-HD is a double-blind, randomised, placebo-controlled, 12-week trial.
In the ARC-HD trial, the treatment compliance rates were found to be higher than 90% for the nearly three-year open-label extension period.
Additionally, evaluation with the Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score showed that treatment with Austedo boosted and preserved chorea control in the Rollover cohort and the Switch cohort.
An inhibitor of vesicular monoamine transporter 2 (VMAT2), Austedo received the US Food and Drug Administration approval to treat tardive dyskinesia (TD) and for chorea linked to HD in adults.
Teva Specialty R&D senior vice-president, global head Eran Harary said: “Chorea is one of the most striking physical manifestations of Huntington’s disease that occurs in approximately 90% of HD patients.
“As a disease that can have a significant functional impact on patients’ and caregivers’ lives, we’re proud to share these new data to provide valuable insights for this community of patients and for those who provide care to them each day.”
HD is a rare and fatal neurodegenerative ailment while chorea is a physical manifestation of the disease.
In February 2020, Teva reported that deutetrabenazine failed to meet the primary endpoint in Phase II/III ARTISTS 1 and Phase III ARTISTS 2 trials in paediatric patients with moderate to severe Tourette syndrome.