Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder

Rhea-AI Summary

Neurocrine Biosciences (NBIX) initiates Phase 2 clinical study for NBI-1070770 in major depressive disorder, showing promising potential as a novel treatment. The study aims to evaluate safety, efficacy, and tolerability in adults, with a focus on NMDA NR2B receptor modulation.

Medical Research Analyst

The initiation of a Phase 2 clinical trial for NBI-1070770 by Neurocrine Biosciences marks a significant step in the development of new treatments for major depressive disorder (MDD). The focus on the NR2B subunit-containing NMDA receptors is based on a growing body of evidence suggesting their role in the pathophysiology of depression. The selectivity of NBI-1070770 could potentially offer a more targeted therapy with fewer side effects compared to less selective NMDA receptor modulators currently on the market.

From a medical research perspective, the use of the Montgomery-Åsberg Depression Rating Scale as a primary endpoint is a standard and reliable method to assess changes in depression severity. This scale is widely used in clinical trials for antidepressants, allowing for comparison across different studies. The outcome of this trial will be important in determining the compound's efficacy and safety profile, which, if positive, could lead to a novel and effective treatment option for patients with MDD.

Financial Analyst

In terms of financial implications, the advancement of NBI-1070770 into Phase 2 trials could be a positive signal to investors about Neurocrine Biosciences' pipeline strength. The market for antidepressants is substantial, with a significant portion of the population affected by MDD. A successful novel treatment could capture a sizeable market share, especially if it demonstrates advantages over existing therapies. Investors should monitor the trial's progress closely, as positive results could lead to an increase in the company's stock value, while any setbacks could have the opposite effect.

It is important to note that drug development is a high-risk venture, with many compounds failing to make it to market. As such, while the potential rewards are significant, the risks are equally high. Investors should consider the broader portfolio and pipeline diversification of Neurocrine Biosciences when evaluating the company's long-term potential.

Psychiatrist

As a psychiatrist, the development of NBI-1070770 is noteworthy due to its mechanism of action. Current treatments for MDD, such as SSRIs and SNRIs, do not work for all patients and there is a need for therapies with different mechanisms. A negative allosteric modulator of the NMDA NR2B receptor could potentially offer a new avenue for treatment-resistant patients. This could change the standard of care for MDD, potentially leading to a shift in prescribing practices should the compound prove to be effective and well-tolerated.

Additionally, the selectivity for the NMDA NR2B receptor might reduce the likelihood of dissociative side effects associated with other NMDA receptor modulators like ketamine. This could make NBI-1070770 a more viable option for long-term management of MDD. The psychiatric community will be watching the results of this trial with great interest, as it has the potential to impact treatment guidelines and patient outcomes significantly.

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.

Forward-Looking Statement
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the potential benefits of NBI-1070770. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.

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SOURCE Neurocrine Biosciences, Inc.

FAQ

What is the purpose of Neurocrine Biosciences' Phase 2 clinical study for NBI-1070770?

The study aims to evaluate the efficacy, safety, and tolerability of the investigational compound NBI-1070770 in adults with major depressive disorder.

What is NBI-1070770 and how does it function?

NBI-1070770 is a novel, selective, orally active, negative allosteric modulator of the NR2B subunit-containing N-methyl-D-aspartate (NMDA NR2B) receptor, potentially benefiting patients with moderate to severe depression.

How many adults will be enrolled in the Phase 2 study for NBI-1070770?

Approximately 72 adults will be enrolled in the multi-center, randomized, double-blind, placebo-controlled study conducted across the United States.

What is the primary focus of the study in terms of patient outcomes?

The study will assess the safety and efficacy of NBI-1070770 in subjects with major depressive disorder compared to placebo, focusing on improving symptoms of depression as measured by the Montgomery-Åsberg Depression Rating Scale.