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news.Auspex Pharmaceuticals has started patient enrollment in a multi-center Phase III clinical trial of its investigational drug SD-809 (deutetrabenazine) to treat people with tardive dyskinesia, a debilitating and often irreversible movement disorder.
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The trial named AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia) is the company’s second pivotal clinical trial to assess SD-809 in tardive dyskinesia patients.
The company intends to report top-line data from the second AIM-TD clinical trial in 2016.
The first trial of SD-809 ‘ARM-TD’ is a Phase II/III study that was started this year to assess SD-809 as a treatment for tardive dyskinesia and top-line results from it are expected in mid-2015.
Auspex Pharmaceuticals clinical development vice-president Michael Huang said: "The initiation of AIM-TD represents another important milestone for Auspex as we continue to advance the development of SD-809 as a treatment for people with tardive dyskinesia.
"The AIM-TD trial, along with the ARM-TD trial, will provide us an opportunity to evaluate the therapeutic value of SD-809 as a potential new treatment for people battling this debilitating disorder."
Around 200 people with tardive dyskinesia will be enrolled in this double-blind, placebo-controlled, parallel group Phase III AIM-TD trial and they will be randomized 1:1:1:1 to receive three fixed doses of SD-809 or placebo for 12 weeks of treatment.
The company said that the design of this second Phase III trial is similar to that of the ongoing ARM-TD trial.
Primary efficacy endpoint in both the trial’s will be the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to week 12, which will be assessed by a blinded, centralized video rater.
Both the ARM-TD and AIM-TD trials are being conducted at sites in the US and Europe.
Results from these trials are expected to support the submission of a new drug application (NDA) for SD-809 to treat tardive dyskinesia, which is planned in 2016.