Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1076986 in Healthy Adults

Rhea-AI Summary

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has initiated a Phase 1 clinical study for the investigational compound NBI-1076986 targeting movement disorders. The study aims to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults. This compound, an M4 subtype-selective muscarinic acetylcholine receptor antagonist, shows promise for treating conditions like Parkinson's disease tremor and dystonia.

Positive

• Initiation of Phase 1 clinical study demonstrates progress in Neurocrine Biosciences' research and development efforts.

• NBI-1076986, a potential treatment for movement disorders, is a valuable addition to the company's muscarinic portfolio.

• The compound selectively targeting M4 receptors could offer benefits for a wide range of motor coordination disorders.

Negative

• None.

Insights

Medical Research Analyst

The initiation of a Phase 1 clinical study by Neurocrine Biosciences marks a pivotal step in the development of NBI-1076986 as a potential treatment for movement disorders. The focus on the M4 muscarinic acetylcholine receptor is particularly noteworthy, as it implies a targeted approach that could offer a differentiated mechanism of action compared to existing treatments. In terms of investment, the progression into human trials represents a transition from preclinical to clinical development, which could significantly de-risk the compound in the eyes of investors. With movement disorders like Parkinson's disease affecting a large population, the market opportunity is substantial. However, the road from Phase 1 to market approval is long and uncertain. At this stage, safety and tolerability are the key endpoints, with efficacy data still being far on the horizon. Investors should consider both the potential for high reward but also the inherent risks associated with early-stage drug development.

Biotech Market Analyst

Neurocrine Biosciences' announcement of the Phase 1 study commencement signifies an exploratory phase in the commercial viability of NBI-1076986. Historically, the biotech sector witnesses a positive investor response to such milestones, often reflected in short-term stock volatility. However, the practical impact on the company's financials will be minimal at this stage, as revenue generation from NBI-1076986 is still several years away, if it occurs at all. What is important for investors to note is how the development of this compound fits into Neurocrine's broader pipeline and strategy. A successful muscarinic receptor antagonist could position the company as a leader in the niche market for movement disorders, potentially driving long-term growth. Investors should also keep an eye on the competitive landscape and be aware of similar compounds in development by other companies.

SAN DIEGO, May 9, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1076986 in healthy adult participants. NBI-1076986 is an investigational, oral, M4 subtype-selective muscarinic acetylcholine receptor antagonist for the potential treatment of movement disorders that was discovered and developed by Neurocrine Biosciences.

"This compound is an important part of our muscarinic portfolio, which enters the clinic as a potential treatment for movement disorders," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "Selectively targeting M4 receptors could benefit a broad range of motor coordination disorders, including Parkinson's disease tremor and dystonia."

About Muscarinic Pipeline and NBI-1076986
Muscarinic receptors are fundamental to activating signaling pathways in the brain. There are five muscarinic acetylcholine receptors involved in neurotransmission (M1–M5), with M4 receptors associated with motor coordination and certain central nervous system pathologies. M1 receptors play a role in higher cognitive processes such as learning and memory and are thought to be associated with the memory/cognitive side effects associated with non-selective antimuscarinic agents.

Identified and developed by Neurocrine Biosciences, NBI-1076986 is an investigational, oral, M4 subtype-selective muscarinic acetylcholine receptor antagonist for the potential treatment of certain movement disorders, including Parkinson's disease tremor and dystonia. It is hypothesized that an M4 subtype-selective antagonist may impact regulation of motor symptoms and movements while minimizing off-target effects.

Neurocrine Biosciences has a broad portfolio of programs that selectively target muscarinic receptors. In addition to NBI-1076986, the portfolio includes several small molecule M1, M1/M4 and M4 agonists that Neurocrine Biosciences acquired the rights to develop and commercialize from Nxera Pharma (formerly Sosei Heptares). 

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)

The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.

Forward-Looking Statements
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-1076986. 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 quarterly report on Form 10-Q for the quarter ended March 31, 2024. 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 1 clinical study?

Neurocrine Biosciences initiated the Phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational compound NBI-1076986 in healthy adults.

What is NBI-1076986 and its potential use?

NBI-1076986 is an investigational, oral, M4 subtype-selective muscarinic acetylcholine receptor antagonist developed by Neurocrine Biosciences for potential treatment of movement disorders like Parkinson's disease tremor and dystonia.

Who is Eiry W. Roberts?

Eiry W. Roberts is the Chief Medical Officer at Neurocrine Biosciences.