Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) has revealed on Thursday significant results from a second Phase 3 registration trial evaluating SD-809 (duetetrabenazine) for the treatment of tardive dyskinesia (TD), which is also known as the AIM-TD trial.
In line with this, Teva hopes to file a regulatory application to the US Food and Drug Administration (FDA) before the year ends.
SD-809 as TD Treatment
The randomized, double-blind, placebo-controlled AIM-TD clinical trial is a 12-week study that follows the Breakthrough Therapy Designation for SD-809 for the treatment of TD patients granted by the US FDA in November. It has enrolled 288 subjects with moderate-to-severe TD. These latest results also follow the significant results from the ARM-TD trial that had been revealed last year.
The primary endpoint of the AIM-TD clinical trial is the change in Abnormal Involuntary Movement Scale (AIMS) score over the course of 12 weeks for three SD-809 fixed doses. By the 12th week, the 24-mg and 36-mg SD-809 dose groups have demonstrated a significant change in AIMS scores among the subjects. The secondary endpoint of the clinical trial had also been met as the Clinical Global Impression of Change (CGI) improved. The company seeks to present a more elaborate analysis soon.
Positive Implications
Michael Hayden, M.D., Ph.D., Teva Pharmaceutical Industries Chief Scientific Officer (CSO) and President of Global Research and Development (R&D), has noted that the new positive results from the latest clinical trial signifies an important milestone not just for the company but for TD patients as well.
Hubert Fernandez, M.D., AIM-TD Co-Principal Investigator, has boasted that the results clearly establish the tolerability, safety, and efficacy of SD-809 for the treatment of TD.
TD is a hyperkinetic movement condition that involves repetitive, uncontrollable movements of different parts of the body. In the US, roughly half a million individuals suffer from the said disorder. TD is directly associated with medications for conditions such as bipolar disorder and schizophrenia. Presently, no treatments are available for TD patients in the US. The AIM-TD clinical trial and the latest positive results can potentially change the current situation.
Teva Pharmaceutical Industries closed Thursday’s session at $51.23 after reaching an intraday high of $51.45 and an intraday low of $50.60. The stock has a 52-week high of $66.55.
