Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder
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The recent advancement by Neurocrine Biosciences in their Phase 2 SAVITRI study for NBI-1065845 presents a noteworthy development within the mental health pharmaceutical landscape. Considering the Montgomery Åsberg Depression Rating Scale (MADRS) is a widely recognized instrument for gauging the severity of depressive episodes, the reported statistically significant reduction in MADRS scores suggests a potential therapeutic efficacy of NBI-1065845 for Major Depressive Disorder (MDD) patients inadequately served by existing treatments.
From a medical research perspective, the tolerability profile is encouraging, particularly the comparable adverse event profile to placebo and the absence of serious adverse events or deaths. Headaches being the most common adverse event might not compromise the drug's acceptance, provided its benefits substantiate. With no deaths or serious adverse events reported, the therapy could potentially offer a favorable risk-benefit profile, a critical factor in FDA approval decisions and subsequent physician adoption.
Neurocrine Biosciences' progress with NBI-1065845 could represent a substantial market opportunity. The MDD treatment market is sizable, with a high unmet need for novel therapies. The clear statistical significance reported in primary and secondary endpoints at Day 28 and Day 56 could strengthen investor confidence in the drug's commercial potential.
It's important to note that while Phase 2 results are promising, the true test lies ahead in Phase 3 trials and eventual market acceptance. Investors should monitor upcoming meetings with the FDA as they will shape the drug's development timeline and cost. A drug's progression into Phase 3 generally leads to increased R&D expenditures; however, it also moves the drug one step closer to potential approval and revenue generation. The long-term prospects depend on Phase 3 outcomes, regulatory hurdles and the ability to penetrate the existing market, outpacing competitors.
The demand for innovative MDD treatments is on the rise, attributed to both an increasing prevalence of depression and a growing recognition of the condition's impact on quality of life. NBI-1065845, as a potential first-in-class AMPA positive allosteric modulator, positions Neurocrine Biosciences favorably in a competitive market if further trials confirm these findings.
Understanding that AMPA PAMs represent a novel mechanism of action in addressing synaptic dysfunction in MDD, market differentiation could be significant. If successfully developed, NBI-1065845 could appeal not only to patients with inadequate response to current antidepressants but also to healthcare providers looking for new avenues of treatment. The drug's efficacy and safety profile may influence prescribing decisions in an increasingly crowded marketplace, where differentiation is key to commercial success.
- SAVITRI™ Study Met Primary Endpoint with Statistically Significant Reduction in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
- Met Key Secondary Endpoints, Including Statistically Significant Reduction in MADRS Score at Day 56
- NBI-1065845 Was Generally Well-Tolerated
The study met its primary and key secondary endpoints, demonstrating that once-daily, oral administration of NBI-1065845 produced a statistically significant change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 (primary) and Day 56 (secondary). In the full analysis data set, the least squares (LS) mean differences from baseline in MADRS total score for NBI-1065845 were:
- One of the doses demonstrated an improvement over placebo of -4.3 (p-value = 0.0159) and -7.5 (p-value = 0.0016) at Day 28 and Day 56, respectively.
- The other dose also demonstrated a trend toward improvement over placebo of -3.0 (p-value = 0.0873) and -3.6 (p-value = 0.1082) at Day 28 and Day 56, respectively.
NBI-1065845 was generally well tolerated. The most common adverse event was headache. The adverse event profile for both doses of NBI-1065845 were comparable to placebo. There were no deaths or serious adverse events. The discontinuation rates were low throughout the study.
"Many millions of people living with major depressive disorder do not benefit fully from currently available treatments and experience persistent debilitating symptoms," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "NBI-1065845 has the potential to be a first-in-class treatment to alleviate many of these symptoms of MDD. The Phase 2 data from the SAVITRI study are very encouraging, and we look forward to meeting with the FDA to discuss a path into Phase 3 studies."
Additional data from the SAVITRI study will be shared at a future scientific conference.
About the Phase 2 SAVITRI™ Study
The Phase 2 SAVITRI™ study is a double-blind, placebo-controlled study designed to assess the efficacy and safety of investigational NBI-1065845 in adult subjects with major depressive disorder (MDD). The study enrolled 183 adults with a primary diagnosis of MDD and who had inadequate response to current antidepressant treatment.
About NBI-1065845
NBI-1065845 is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in development as a potential treatment for patients with inadequate response to treatment in MDD.
About the Collaboration with Takeda
In 2020, Neurocrine Biosciences and Takeda (TSE:4502/NYSE:TAK) entered into a strategic collaboration to develop and commercialize compounds in Takeda's early-to-mid-stage psychiatry pipeline, including an exclusive license to NBI-1065845 (TAK-653). Under the terms of the agreement, Neurocrine Biosciences is responsible for developing and commercializing all compounds included in the collaboration and for compounds other than NBI-1065845 and NBI-1065846, Takeda is eligible to receive development or commercial milestone payments and royalties. For NBI-1065845 and NBI-1065846, Takeda may elect to opt out of a 50:50 profit share at certain development events on a program-by-program basis. Until such time Takeda elects to opt out of either profit share arrangement, it will not be eligible to receive development or commercial milestone payments.
About Major Depressive Disorder
Major depressive disorder (MDD) is a mental health disorder characterized by a persistently depressed mood, loss of interest, lack of enjoyment in daily activities, poor concentration, and decreased energy. MDD is one of the leading causes of disability. More than 21 million people in the
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 and SAVITRI are trademarks 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 regarding the clinical results from, and our future development plans with respect to, NBI-1065845, as well as the therapeutic potential and clinical benefits or safety profile of NBI-1065845. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: top-line data that we report may change following a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of the clinical study; risks that regulatory submissions for our products and/or product candidates may not occur or be submitted in a timely manner; our products and/or product candidates may not obtain regulatory approvals; or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding our products and/or product candidates; our products and/or product candidates will not be found to be safe and/or effective or may not prove to be beneficial to patients; that development activities for our products and/or product candidates may not be completed on time or at all; that clinical development activities may be delayed for regulatory or other reasons, may not be successful or replicate previous and/or interim clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical trials; competitive products and technological changes that may limit demand for our products; uncertainties relating to patent protection and intellectual property rights of third parties; our dependence on third parties for development and manufacturing activities related to our products and our product candidates, and our ability to manage these third parties; our future financial and operating performance; risks and uncertainties associated with the commercialization of 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.
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