Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced a significant operational update today regarding its clinical pipeline. The company has officially initiated a Phase 2 clinical study for its investigational compound, NBI-1065890. This trial will evaluate the compound’s effectiveness in treating adults with tardive dyskinesia (TD).
NBI-1065890: A Next-Generation VMAT2 Inhibitor
NBI-1065890 functions as a selective inhibitor of the vesicular monoamine transporter 2 (VMAT2). Neurocrine discovered and developed this molecule internally. It represents a next-generation approach to VMAT2 inhibition.
The compound possesses distinct physical and chemical properties. Consequently, Neurocrine designed it to deliver a differentiated clinical profile. This includes the potential for longer-acting treatment options for patients.
Dr. Sanjay Keswani, Chief Medical Officer at Neurocrine Biosciences, highlighted the strategic importance of this milestone. He noted that the molecule’s unique properties might benefit a broader range of patients. Furthermore, moving this program into Phase 2 is a critical step in the company’s strategy to define the future of VMAT2 biology.
Study Methodology and Design
The newly initiated study employs a rigorous clinical design. It is a Phase 2, randomized, double-blind, placebo-controlled trial. The company plans to enroll approximately 100 adult subjects diagnosed with TD.
The primary objective is to assess the efficacy, safety, and tolerability of NBI-1065890 compared to a placebo. Specifically, the study uses the Abnormal Involuntary Movement Scale (AIMS). The primary efficacy endpoint is the change from baseline in the AIMS dyskinesia total score at Week 8.
Corporate Expertise in Neurology
Neurocrine Biosciences holds established expertise in this therapeutic area. The company successfully developed valbenazine, a selective VMAT2 inhibitor. In 2017, valbenazine became the first drug ever approved by the U.S. Food and Drug Administration (FDA) for the treatment of tardive dyskinesia.
Subsequently, the FDA approved valbenazine in 2023 for chorea associated with Huntington’s disease. The current Phase 2 study for NBI-1065890 builds upon nearly two decades of the company’s scientific experience in VMAT2 inhibition.
Understanding Tardive Dyskinesia
Tardive dyskinesia is a movement disorder estimated to affect at least 800,000 adults in the United States. It is characterized by uncontrolled, abnormal, and repetitive movements. These movements commonly affect the face, torso, and other body parts.
The condition is often associated with the use of antipsychotic medications prescribed for mental illnesses such as:
- Major depressive disorder
- Bipolar disorder
- Schizophrenia
- Schizoaffective disorder
These treatments can result in irregular dopamine signaling in the brain region controlling movement. The resulting symptoms can range from mild to severe. Moreover, they are frequently persistent and irreversible, negatively impacting the patient’s quality of life.
For further details on the clinical trial, interested parties can reference study NBI-1065890-TD2033 on ClinicalTrials.gov.
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