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news.Auspex Pharmaceuticals, a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, has announced the enrollment of the first two patients in a multi-center pivotal Phase 2/3 clinical trial of its investigational drug, SD-809 (deutetrabenazine), for the treatment of tardive dyskinesia (TD).
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Top-line data from the trial, designated the ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) study, are expected in mid-2015.
"Tardive dyskinesia is a side effect of certain drug treatments for neurological disorders that is often permanent and there are currently no approved therapeutics to treat it," said Michael Huang, M.D., Vice President of Clinical Development at Auspex Pharmaceuticals.
"This pivotal study will provide us an opportunity to evaluate the therapeutic value of SD-809 as a potential new treatment for tardive dyskinesia."
The ARM-TD Phase 2/3 clinical trial of SD-809 for the treatment of drug-induced tardive dyskinesia will involve approximately 90 subjects with moderate to severe TD, who will be randomized 1:1 to receive SD-809 or placebo.
Patients will titrate to their optimal dosage over six weeks, and be treated at that dose for six weeks, for a total of 12 weeks of treatment. The primary efficacy endpoint will be the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end therapy, which will be assessed by centralized video rating.
The safety endpoints include adverse events, vital signs, physical/neurological/laboratory examinations and ECGs. Eligible subjects who complete the Phase 2/3 clinical trial will be offered a long-term safety follow-up. Auspex also plans to initiate an additional Phase 3 pivotal clinical trial of SD-809 for the treatment of TD in 2014.
"There is a serious and growing unmet medical need as tardive dyskinesia is one of the most debilitating and often irreversible side effects of dopamine receptor blocking agents, which are increasingly being used in the United States for the treatment of psychosis, behavioral and sleep disorders, or gastrointestinal conditions," said Hubert Fernandez, M.D., Professor of Neurology at the Center for Neurological Restoration at the Cleveland Clinic and Principal Investigator of the SD-809 ARM-TD clinical study.