Neurocrine Biosciences Launches Phase 2 Trial of NBI-1065890 for Tardive Dyskinesia in Adults
Neurocrine Biosciences, Inc. today announced the initiation of its Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation, selective inhibitor of the vesicular monoamine transporter 2 (VMAT2). Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890 to potentially deliver a differentiated profile, including the possibility of longer-acting options for the treatment of TD.
“NBI-‘890 is an internally discovered molecule with distinct physical and chemical properties that may allow it to benefit a broader range of patients with tardive dyskinesia,” said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. “Advancing this program to a Phase 2 clinical study is key to our strategy to define the future of VMAT2 biology and deliver lasting impact for patients.”
This Phase 2, randomized, double-blind, placebo-controlled study will enroll approximately 100 adult subjects with TD and will assess the efficacy, safety, and tolerability of NBI-1065890 compared with placebo. The primary efficacy endpoint is change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (sum of Items 1–7) at Week 8.
Neurocrine successfully developed and received U.S. Food and Drug Administration approval in 2017 for valbenazine, a selective VMAT2 inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington’s disease.
About Tardive Dyskinesia
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD.
In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S.
About NBI-1065890
NBI-1065890, discovered and developed internally at Neurocrine, is a potent, selective and orally bioavailable inhibitor of vesicular monoamine transporter 2 (VMAT2) in clinical development for the treatment of tardive dyskinesia (TD). Inhibition of VMAT2 is expected to provide therapeutic benefit in TD, other hyperkinetic movement disorders, and potentially other CNS disorders where dopaminergic signaling is dysregulated.
About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders.
The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science.
