Teva Pharma's (TEVA) Second Phase III Study of SD-809 in TD Shows Statistically Significant Results

September 22, 2016 8:02 AM EDT

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Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced SD-809 (deutetrabenazine) showed statistically significant results in the second Phase III registration trial studying the potential of SD-809 for the treatment of tardive dyskinesia (TD). These new results for the AIM-TD trial follow positive results from the ARM-TD trial announced in June 2015. Both ARM-TD and AIM-TD were 12 week treatment studies. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for SD-809 for the treatment of TD in November 2015. Teva expects to make a regulatory submission to the FDA by the end of 2016.

“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,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva, adding that “The study results strengthen our resolve to making this product an option for those patients in need. We are grateful to the trial participants and study investigators who contributed to this study.”

In the AIM-TD trial, the primary endpoint was change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to week 12 for three fixed doses of SD-809 as compared to placebo. Patients’ abnormal movements were assessed by blinded central video rating. All doses improved AIMS scores compared to placebo and at week 12, the 24 mg and 36 mg dose groups of SD-809 demonstrated a significant change from baseline based on the modified intent-to-treat population.

At week 12, the AIMS rating improved from baseline by -3.3 points for 36 mg (P=0.001), -3.2 points for 24 mg (P=0.003) and -2.1 for 12 mg (P=NS), compared to -1.4 in placebo. In addition to the primary endpoint, mean scores on the Clinical Global Impression of Change (CGI) improved by -0.5 for 36 mg (P=0.011) and by -0.6 for 24 mg (P=0.002) based on the modified intent-to-treat population. The CGI is a global assessment of the patient’s abnormal movements made by the treating investigator. For the protocol-specified secondary endpoint of CGI, in which treatment success was defined as “much improved” or “very much improved” at Week 12 and missing data were counted as treatment failure, 24 mg was superior to placebo (P=0.014); the 36 mg dose was superior to placebo, but did not reach statistical significance (P=0.059). Teva will present a fuller analysis at a future medical meeting.

“The results from the AIM-TD trial suggest clear efficacy and an excellent safety profile for SD-809. The remarkably low rates of neuropsychiatric adverse events observed is particularly important for this psychiatric patient population” said Hubert H. Fernandez, MD, Professor of Medicine (Neurology) at the Cleveland Clinic Lerner College of Medicine and co-Principal Investigator for the trial. “The relevance of the efficacy data on the AIMS is underscored by the improvement observed on the Clinical Global Impression of change, which demonstrates that treating clinicians appreciated the reduction in abnormal movements experienced by their patients.”

During the 12-week treatment, SD-809 demonstrated a favorable safety and tolerability profile. The frequency of overall adverse events and adverse events leading to withdrawal were similar among all treatment groups. The safety profile of SD-809 was consistent with data from previously reported clinical trials.

Tardive dyskinesia is a hyperkinetic movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The often debilitating disorder affects about 500,000 people in the United States and is a result of treatment with medications used to treat psychiatric conditions such as schizophrenia and bipolar disease. There are currently no approved medications for this condition in the United States.

About the AIM-TD Study

AIM-TD was a phase III, randomized, double-blind, placebo-controlled, parallel group, fixed-dose study of 288 male and female adults with moderate to severe TD. 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 underwent dose escalation during the initial 4 weeks, followed by an 8-week maintenance period and a 1-week washout. For further details on the AIM-TD study, visit https://clinicaltrials.gov/ct2/show/NCT02291861

About SD-809 (deutetrabenazine) Tablets

SD-809 (deutetrabenazine) is an investigational, oral, small-molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is being developed for the treatment of chorea associated with Huntington disease (HD). Deutetrabenazine has been granted Orphan Drug Designation for the treatment of HD by the U.S. Food and Drug Administration (FDA). Teva is also investigating the potential of deutetrabenazine for treating tardive dyskinesia, for which the FDA has granted a breakthrough therapy designation, and for tics associated with Tourette syndrome, for which the FDA has granted orphan status for pediatric use. Deutetrabenazine uses Teva’s deuterium technology.



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