NBI-1117568

Last updated
NBI-1117568
Clinical data
Other namesHTL-0016878; NBI-1117568; NBI-568
Routes of
administration
Oral
Drug class Muscarinic acetylcholine M4 receptor agonist

NBI-1117568 (former developmental code name HTL-0016878) is an investigational antipsychotic drug for schizophrenia that was out-licensed Nexera Pharma in to Neurocrine Biosciences, a United States-based pharmaceutical company. [1] [2] It is administered orally. [3] [4]

Contents

Overview

It is a selective muscarinic acetylcholine M4 receptor agonist that indirectly modulates dopamine as the basis for its putative improvement of schizophrenia. [3] In April 2016, the compound was out-licensed to Allergan, an Irish pharmaceutical company. By September 2017, it had advanced to Phase I clinical trial for the indication of "neuropsychiatric symptoms associated with Alzheimer's disease and other dementias" [5] However, in May 2020, Allergan was acquired by AbbVie, and due to AbbVie's pipeline business decisions, the license was returned to Nexceris in January 2021. [6] In November 2021, the compound was newly out-licensed to Neurocrine Biosciences, a U.S. pharmaceutical company. [2] It has been under development as a treatment for schizophrenia, and as of September 2024, Phase II clinical trials have been completed. [7] [8]

History

Clinical trials

Phase II clinical trial

The Phase II clinical trial was conducted in 15 sites across the U.S. with 200 adult patients diagnosed with schizophrenia. [16] The primary endpoint was assessed by the change in the total score of the Positive and Negative Syndrome Scale (PANSS) after six weeks of treatment. The 20 mg once-daily group showed a statistically significant improvement of 7.5 points compared to the placebo group (improvement of 18.2 points from baseline, p = 0.011, effect size = 0.61). [17] However, the 40 mg once-daily group, 60 mg once-daily group, and 30 mg twice-daily group did not show statistically significant differences compared to the placebo group (p-values: 40 mg group: 0.282, 60 mg group: 0.189, 30 mg twice-daily group: 0.090). [17]

Market reaction to phase II clinical trial

With a PANSS improvement of 7.5, NBI-111758 lagged behind xanomeline/trospium (KarXT) (Karuna Therapeutics) with 8.4 and emraclidine (Cerevel Therapeutics) with 12.7, both of which were in clinical trials at the same time. Moreover, the lack of dose-dependency led to disappointment in the stock market. [18] Neurocrine Biosciences' share price dropped 19% on the day following the announcement of the Phase II clinical trial results. [19]

See also

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References

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  10. "アルツハイマー病等の主要症状の治療薬として開発中の新薬候補、 選択的ムスカリンM4受容体作動薬の第I相臨床試験で最初の被験者への投与を実施" (PDF). ネクセラファーマ(旧そーせいグループ株式会社). 2017-09-01. Retrieved 2024-09-17.
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