Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1065890, a Second-Generation VMAT2 Inhibitor, in Healthy Adults

Rhea-AI Summary

Neurocrine Biosciences, Inc. (NBIX) has initiated a Phase 1 clinical study for NBI-1065890, an investigational compound targeting neurological and neuropsychiatric conditions. The company aims to leverage its expertise in VMAT2 inhibition, following the success of valbenazine for tardive dyskinesia and Huntington's disease chorea.

Pharmacology Expert

The initiation of a Phase 1 clinical study for Neurocrine Biosciences' compound NBI-1065890 marks a significant step in the development of new treatments for neurological and neuropsychiatric conditions. As a selective inhibitor of the vesicular monoamine transporter-2 (VMAT2), this compound could potentially offer improvements over existing treatments in terms of efficacy or side effect profiles. VMAT2 is critical for the regulation of neurotransmitter release from synaptic vesicles and its inhibition has been shown to alleviate symptoms of hyperkinetic movement disorders such as tardive dyskinesia.

Given that Neurocrine Biosciences has previously navigated the FDA approval process successfully with valbenazine, their experience could streamline the development pathway for NBI-1065890. However, it is important to note that Phase 1 trials primarily focus on safety and tolerability rather than efficacy and thus the commercial viability of NBI-1065890 remains uncertain at this stage. The results from this study will provide valuable insights into the pharmacokinetics and pharmacodynamics of the compound, which are essential for dose optimization in later trial phases.

Financial Analyst

The announcement of a Phase 1 clinical trial by Neurocrine Biosciences could have implications for investor sentiment and the company's stock valuation. The development of NBI-1065890 is particularly noteworthy given the company's track record with VMAT2 inhibitors. The market for neurological and neuropsychiatric treatments is substantial and a successful new drug in this space could lead to significant revenue streams for Neurocrine.

However, investors should consider the inherent risks associated with drug development. The majority of drugs that enter Phase 1 trials do not make it to market and the investment required for clinical trials is substantial. The long-term potential of NBI-1065890 will depend on its ability to demonstrate safety and efficacy in subsequent trials and to differentiate itself from existing treatments. For now, the impact on Neurocrine's financials is speculative, with actual returns, if any, lying several years in the future.

Medical Research Analyst

The landscape of treatments for neurological and neuropsychiatric conditions is highly competitive, with numerous companies aiming to bring innovative therapies to market. Neurocrine Biosciences' prior success with valbenazine provides a foundation of expertise that may benefit the development of NBI-1065890. The compound's progression into Phase 1 trials is a critical first step in understanding its potential impact on patient care.

It is essential to monitor the data emerging from these early-stage trials to assess not only the safety profile of NBI-1065890 but also any preliminary indications of its pharmacological action. Given the complexity of neuropsychiatric disorders and the diversity of patient responses to treatment, a new VMAT2 inhibitor could offer a valuable alternative if it shows differentiated benefits or an improved safety profile compared to existing therapies. The long-term research and development trajectory for NBI-1065890 will be a key factor in determining its potential market share and impact on Neurocrine Biosciences' growth.

SAN DIEGO, March 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1065890 in healthy adult participants. NBI-1065890 is an investigational, oral, selective inhibitor of the vesicular monoamine transporter-2 (VMAT2) for the potential treatment of certain neurological and neuropsychiatric conditions.  

"Neurocrine has deep scientific expertise and experience in VMAT2 inhibition, exemplified by the successful discovery and development of valbenazine for the treatment of tardive dyskinesia and chorea in Huntington's disease," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "We're excited to bring this next-generation, internally discovered, highly potent, oral, selective VMAT2 inhibitor into the clinic with the hope of providing differentiated benefit in treating certain neurological and neuropsychiatric conditions."

VMAT2 small molecule inhibitors have been clinically validated as effective treatments for hyperkinetic movement disorders, playing an important role in presynaptic dopamine storage and release. Neurocrine successfully developed and received U.S. Food and Drug Administration approval in 2017 for valbenazine, a selective VMAT2 inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington's disease.

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-1065890. 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.

What is the ticker symbol for Neurocrine Biosciences, Inc.?

The ticker symbol for Neurocrine Biosciences, Inc. is NBIX.

What is the purpose of the Phase 1 clinical study initiated by Neurocrine Biosciences?

The Phase 1 clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1065890 in healthy adult participants.

What is NBI-1065890 and its potential application?

NBI-1065890 is an investigational, oral, selective inhibitor of the vesicular monoamine transporter-2 (VMAT2) for the potential treatment of certain neurological and neuropsychiatric conditions.

What previous success has Neurocrine Biosciences had in VMAT2 inhibition?

Neurocrine Biosciences successfully developed valbenazine, a selective VMAT2 inhibitor, approved by the FDA for tardive dyskinesia and Huntington's disease chorea.

What is the significance of VMAT2 small molecule inhibitors in medical treatment?

VMAT2 small molecule inhibitors have been clinically validated as effective treatments for hyperkinetic movement disorders, impacting presynaptic dopamine storage and release.