Clinical Trials

Date: 2017-05-18

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the American Psychiatric Association (APA) Annual Meeting

Company: Neurocrine Biosciences (USA - CA)

Product: Ingrezza® (valbenazine - NBI-98854)

Action mechanism:

• VMAT2 inhibitor.  Tardive dyskinesia is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. These symptoms are associated with chronic exposure to dopamine receptor blockers such as antipsychotic medications and can be severe, persistent and irreversible. In some cases, they can even interfere with speech, walking, swallowing and breathing.
• NBI-98854 is a potent, highly selective, VMAT2 (Vesicular monoamine transporter 2) inhibitor that is effective in regulating the levels of dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines.  This selectivity may reduce the likelihood of “off target” side effects.

 

Disease: tardive dyskinesia

Therapeutic area: Neurological diseases

Country: Canada, Puerto Rico, USA

Trial details:

• The Kinect 3 study is a randomized, parallel-group, double-blind, placebo-controlled, Phase III clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder). The primary endpoint in the Kinect 3 study is the mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded central raters. The Kinect 3 study will include approximately 240 subjects randomized to either placebo, once daily 40mg of NBI-98854 or once daily 80mg of NBI-98854 for six weeks. Subsequent to the completion of the six week placebo-controlled dosing, all subjects will continue on once daily 40mg or once daily 80mg of NBI-98854 through Week 48. (NCT02274558)

Latest news:

• • On May 18, 2017, Neurocrine Biosciences announced the presentation at the American Psychiatric Association (APA) Annual Meeting of pharmacokinetic data, as well as long-term data from the KINECT 3 Phase III extension study of Ingrezza® (valbenazine) capsules for the treatment of adults with tardive dyskinesia.
• • On March 21, 2017, Neurocrine Biosciences announced that positive results from the Kinect 3 Phase III study of Ingrezza® (valbenazine) for the treatment of tardive dyskinesia were published online by the American Journal of Psychiatry . Once-daily Ingrezza® demonstrated a significant and meaningful reduction in tardive dyskinesia symptoms compared with placebo in participants with underlying schizophrenia, schizoaffective disorder or mood disorder. Ingrezza® was found to be generally well tolerated with adverse events consistent with those of prior studies.
• The study met its primary endpoint of change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at week six in the 80mg once-daily dosing group compared to placebo as assessed by expert central blinded video raters. The mean change from baseline to week six in the AIMS rating was -3.2 for the 80mg once-daily group as compared to -0.1 in the placebo group (p>0.0001).
• In addition, the percentage of participants who achieved an AIMS response (defined in the study as a reduction greater than or equal to 50 percent from baseline in dyskinesia score) was higher in the Ingrezza® 80mg/day group compared to placebo at all study visits. At week six, 40 percent (p<0.001) of participants receiving 80mg/day of Ingrezza® had at least a 50% improvement in AIMS dyskinesia score as compared to only 8.7 percent of those who received placebo.
• During the six-week placebo-controlled treatment period Ingrezza® was generally well tolerated and the most common adverse reactions were somnolence and drooling. The frequency of adverse events was similar among all treatment groups and treatment emergent adverse effects were consistent with those of prior studies. There were no drug-drug interactions identified in subjects who were utilizing a wide range of psychotropic and other concomitant medications.
• • On March 2, 2016, Neurocrine Biosciences announced that data from the Phase III Kinect 3 study of valbenazine (NBI-98854) for tardive dyskinesia will be presented during a plenary session at the American Academy of Neurology Annual Meeting in Vancouver ("KINECT 3: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Valbenazine (NBI-98854) for Tardive Dyskinesia,")
• • On August 13, 2015, Neurocrine Biosciences announced  that it has recently completed subject randomization of the Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Monoamine Transporter 2 (VMAT2) compound NBI-98854 in tardive dyskinesia patients.Topline efficacy data from the initial six week assessment is expected in the fourth quarter of 2015. In addition to this tardive dyskinesia study, a separate one-year open-label safety study of NBI-98854, Kinect 4, has also been initiated to support the anticipated 2016 filing of a New Drug Application in tardive dyskinesia.

Is general: Yes