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Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the ...

Key Takeaway: Neurocrine Biosciences announced the first patient has been dosed in its Phase 2 clinical study for NBI-1070770, a novel treatment for major depressive disorder. This double-blind study aims to assess the efficacy, safety, and tolerability of NBI-1070770 compared to placebo. The investigational compound selectively modulates the NMDA NR2B receptor, which is hoped to benefit patients suffering from moderate to severe depression. Approximately 72 adults will be enrolled in the study, conducted at multiple centers across the United States.

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POSITIVE FACTORS

  • First patient dosed in Phase 2 clinical study for NBI-1070770.
  • NBI-1070770 has the potential to benefit patients with moderate to severe depression.
  • The compound acts through a clinically validated mechanism of action.

Full Press Release Details

SAN DIEGO , April 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder. 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.
"Based upon our Phase 1 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," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "The selectivity of NBI-1070770 for the NMDA NR2B receptor has the potential to benefit patients who have moderate to severe depression."
The NBI-1070770 Phase 2 multi-center, randomized, double-blind, placebo-controlled study will enroll approximately 72 adults and is being conducted at centers throughout the United States . The study will evaluate the safety and efficacy of NBI-1070770 in subjects with major depressive disorder compared to placebo on improving symptoms of depression as measured by the Montgomery-Åsberg Depression Rating Scale. For more information about the Phase 2 study (NBI-1070770-MDD2029), visit Clinicaltrials.gov .
Neurocrine Biosciences acquired the rights to develop and commercialize NBI-1070770 from Takeda Pharmaceutical Company, Ltd.
About Neurocrine Biosciences Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, 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. For more information, visit neurocrine.com , and follow the company on LinkedIn , X (formerly Twitter) , and Facebook . (* in collaboration with AbbVie)
NEUROCRINE BIOSCIENCES, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc.
SOURCE Neurocrine Biosciences, Inc.

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Frequently Asked Questions

What is NBI-1070770 being tested for?

NBI-1070770 is being evaluated for major depressive disorder.

How many participants will the Phase 2 study enroll?

The Phase 2 study will enroll approximately 72 adults.

What is the design of the clinical study?

The study is randomized, double-blind, and placebo-controlled.

Who developed NBI-1070770?

Neurocrine acquired NBI-1070770 from Takeda Pharmaceutical Company.

How will the study measure depression symptoms?

Symptoms will be measured using the Montgomery-Åsberg Depression Rating Scale.

Last updated: Apr 3, 2024