Clinical Trials

Date: 2017-04-27

Type of information: Publication of results in a medical journal

phase: 3

Announcement: results

Company: Teva Pharmaceutical Industries (Israel)

Product: SD-809 - deutetrabenazine

Action mechanism:

• protein inhibitor/VMAT2 inhibitor. SD-809 (deutetrabenazine) is a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of dopamine in the brain. SD-809 is being developed for the treatment of chorea associated with Huntington’s disease. SD-809 (deutetrabenazine) is Auspex Pharmaceuticals's lead investigational product.
• SD-809 became part of Teva’s central nervous system (CNS) product portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.

Disease: tardive dyskinesia

Therapeutic area: Neurological diseases - CNS diseases

Country: Czech Republic, Poland, Slovakia, USA

Trial details:

• The ARM-TD study was a 1:1 randomized, double-blind, placebo-controlled, parallel-group study of 117 patients globally (104 patients completed the study) with moderate to severe tardive dyskinesia. Enrolled patients received either SD-809 or placebo, which was titrated to optimal dosage over the course of six weeks, and then administered at that dose for another six weeks for a total treatment of 12 weeks. The objectives of the study were to evaluate the efficacy of SD-809 in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia and to evaluate the safety and tolerability of titration and maintenance therapy with SD-809 in subjects with drug-induced tardive dyskinesia. (NCT02195700)

Latest news:

• • On April 27, 2017, Teva Pharmaceutical announced the publication of results from the Phase II/III study ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) in Neurology®, the medical journal of the American Academy of Neurology. The ARM-TD study evaluated the safety and efficacy of the investigational use of deutetrabenazine (SD-809) compared to placebo in the treatment of moderate to severe tardive dyskinesia.
•  Results showed that deutetrabenazine significantly reduced Abnormal Involuntary Movement Scale (AIMS) scores from baseline to week 12 vs placebo. No worsening in parkinsonism, as measured by the Unified Parkinson's Disease Rating Scale motor subscale, was noted from baseline to week 12 in either group. Deutetrabenazine was well tolerated and significantly reduced abnormal movements.
• The ARM-TD study and publication was led by Principal Investigators Hubert Fernandez , M.D., Professor of Neurology at the Center for Neurological Restoration at the Cleveland Clinic and Karen E. Anderson , M.D., Associate Professor of Psychiatry & Neurology at Georgetown MedStar University Hospital .
• • On June 16, 2015, Teva Pharmaceutical Industries announced positive top-line results from the pivotal clinical study Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD) designed to evaluate the efficacy of SD-809 (deutetrabenazine) in the treatment of moderate to severe tardive dyskinesia. Top-line data showed that the study met its primary endpoint and demonstrated a positive trend in all secondary endpoints. Importantly, the study also showed a favorable safety and tolerability profile, including low rates of depression, somnolence, insomnia and akathisia. The primary endpoint of ARM-TD was the change in the Abnormal Involuntary Movement Scale from baseline to end of therapy, assessed by blinded centralized video rating. The study results show patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score from baseline to end of therapy compared to 1.6 points in placebo (p = 0.0188) for a clinically meaningful effect. Study results also demonstrated a favorable safety and tolerability profile of SD-809. Fewer patients taking SD-809 than placebo experienced serious adverse events (SAEs) Three patients discontinued from the study for adverse events (1 in SD-809 group vs. 2 in placebo group). For all other side effects reported in the study, rates in the SD-809 group were similar or lower than the placebo group. Further analysis of the additional data from the study is ongoing and details will be shared at future medical meetings and through peer-reviewed publication.

Is general: Yes