First-Patient Dosed in Phase II Clinical Trial Evaluating NBI-1070770 in Adults with Major Depressive Disorder
NBI-1070770 is a novel, selective, and orally active, negative allosteric modulator.
The first patient has been randomized in a Phase II clinical trial which is evaluating NBI-1070770 in adults with major depressive disorder, according to a press release.1 Neurocrine Biosciences’ NBI-1070770 is a novel, selective, and orally active, negative allosteric modulator (NAM) of the NR2B subunit-containing N-methyl-D-aspartate (NMDA NR2B) receptor.
The Phase II trial (NCT06267846) is multi-center, randomized, double-blind, placebo-controlled study that will enroll approximately 72 adults and is being conducted at centers throughout the United States. It will evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to a placebo on improving symptoms of depression based on measurements by the Montgomery-Åsberg Depression Rating Scale.
The study is estimated to be completed in December 2025, with a primary completion in September 2025.
According to the National Institute of Mental Health, major depression is one of the most common mental disorders in the United States. Among US adults aged 18 or older in 2021, an estimated 21.0 million had at least one major depressive episode. This number represented 8.3% of all US adults.2
"Based upon our Phase I first-in-human study, we are excited to bring this novel oral compound, which acts through a clinically validated mechanism of action, into clinical development as a potential treatment for major depressive disorder," Eiry W. Roberts, MD, chief medical officer of Neurocrine Biosciences said in the press release. "The selectivity of NBI-1070770 for the NMDA NR2B receptor has the potential to benefit patients who have moderate to severe depression."
References
1. Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder. News release. April 3, 2024. Accessed April 5, 2024. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-first-patient-dosed-in-phase-2-clinical-study-evaluating-nbi-1070770-in-adults-with-major-depressive-disorder-302106187.html
2. Major Depression. National Institute of Mental Health. Updated July 2023. Accessed April 5, 2024. https://www.nimh.nih.gov/health/statistics/major-depression
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