Teva’s second phase III study of SD-809 in TD shows statistically significant results

SD-809 is an investigational, oral, small-molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is being developed to treat chorea associated with Huntington disease.

The positive data follow successful results from an earlier phase III, ARM-TD, unveiled in June last year. Teva plans to file a new drug application in the US by the end of this year.

In November 2015, SD-809 secured breakthrough therapy designation from the US Food and Drug Administration for the treatment of TD.

In the second phase III registration trial, SD-809 showed a statistically significant improvement in Abnormal Involuntary Movement Scale (AIMS) score.

All patients had a total motor AIMS ≥ 6 at screening and were randomized at baseline in a 1:1:1:1 ratio to receive one of three fixed-dose regimens of deutetrabenazine (12 mg/day, 24 mg/day, 36 mg/day) or placebo.

Patients’ abnormal movements were evaluated by blinded central video rating.

The company said all doses improved AIMS scores compared to placebo and at week 12, the 24 mg and 36 mg dose groups of SD-809 showed a significant change from baseline based on the modified intent-to-treat population.

Teva Pharmaceutical Industries president of global R&D and chief scientific officer Michael Hayden said: “We are delighted to deliver positive results from a second Phase III study showing the potential for SD-809 to treat the involuntary movements of tardive dyskinesia. This condition is debilitating and often leads to isolation of those affected.

“The study results strengthen our resolve to making this product an option for those patients in need.”

Image: Teva in Markham, Ontario. Photo: courtesy of Raysonho @ Open Grid Scheduler / Grid Engine.