UPDATE: Auspex Pharma Expecting Top-Line Data from Phase 2/3 Trial for SD-809 During Mid 2015
Inc. (Nasdaq: ASPX), a late clinical stage biopharmaceutical company focused on
developing and commercializing novel medicines for the treatment of orphan
diseases, today 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).
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.
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