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NBI-1117568

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NBI-1117568
Clinical data
Other namesHTL-0016878; NBI-1117568; NBI-568
Routes of
administration		Oral
Drug classMuscarinic 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]

Overview

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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

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  • 2016
    • April: The rights to develop and sell NBI-1117568 were transferred from its original developer to Allergan.[9]
  • 2017
    • September: Allergan initiated Phase I clinical trials for NBI-1117568 to treat "neurobehavioral symptoms related to Alzheimer's disease and other conditions."[10]
  • 2021
    • January: Allergan returned the rights to NBI-1117568 to Nexera Pharma.[9]
    • November: The rights were then transferred to Neurocrine Biosciences, which took over the development of NBI-1117568.[11]
  • 2022
    • October: Phase II clinical trials began for NBI-1117568 to treat schizophrenia.[12]
  • 2024
    • April: Neurocrine Biosciences announced that NBI-1117568 had met the requirements of long-term preclinical toxicity tests.[13]
    • August: Neurocrine Biosciences released the results of the Phase II clinical trials.[14][15]

Clinical trials

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Phase II clinical trial

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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

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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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  1. ^ "HTL 0016878". AdisInsight. 2 September 2024. Retrieved 21 October 2024.
  2. ^ a b "ニューロクライン社との統合失調症およびその他の精神神経疾患を対象とした新規ムスカリン受容体作動薬に関するライセンス契約締結のお知らせ". プレスリリース・ニュースリリース配信シェアNo.1｜PR TIMES. PR TIMES. 2021-11-22. Retrieved 2024-09-17.
  3. ^ a b "ネクセラファーマ株価6.5%高 薬候補で毒性試験成功 - 日本経済新聞". 日本経済新聞 電子版. 日本経済新聞社. 2024-04-17. Retrieved 2024-09-17.
  4. ^ "当社提携先のニューロクライン社が、統合失調症を対象にしたNBI-1117568の第II相臨床試験の開始を発表［そーせいグループ］ | NIKKEI COMPASS - 日本経済新聞". 日経コンパス (in Japanese). 日本経済新聞社. 2022-10-28. Retrieved 2024-09-17.
  5. ^ "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.
  6. ^ "ムスカリン作動薬プログラムのグローバルな研究開発権・販売権が返還". プレスリリース・ニュースリリース配信シェアNo.1｜PR TIMES. PR Times. 2021-01-05. Retrieved 2024-09-17.
  7. ^ 日経バイオテクONLINE (2024-09-02). "ネクセラファーマ、統合失調症治療薬候補 NBI-1117568の第II相臨床試験の良好な結果によりニューロクライン社より35百万米ドルのマイルストンを受領". 日経バイオテクONLINE. 日本経済新聞社. Retrieved 2024-09-17.
  8. ^ "ネクセラ---大幅反落、ニューロクラインの株価下落に追随売り | 個別株 - 株探ニュース". kabutan.jp. MINKABU THE INFONOID, Inc. 2024-08-29. Retrieved 2024-09-17.
  9. ^ a b "ムスカリン作動薬プログラムのグローバルな研究開発権・販売権が返還". プレスリリース・ニュースリリース配信シェアNo.1｜PR TIMES. PR Times. 2021-01-05. Retrieved 2024-09-17.
  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.
  11. ^ "ニューロクライン社との統合失調症およびその他の精神神経疾患を対象とした新規ムスカリン受容体作動薬に関するライセンス契約締結のお知らせ". プレスリリース・ニュースリリース配信シェアNo.1｜PR TIMES. PR TIMES. 2021-11-22. Retrieved 2024-09-17.
  12. ^ "当社提携先のニューロクライン社が、統合失調症を対象にしたNBI-1117568の第Ⅱ相臨床試験の開始を発表". プレスリリース・ニュースリリース配信シェアNo.1｜PR TIMES. PR TIMES. 2022-10-28. Retrieved 2024-09-17.
  13. ^ "ネクセラファーマ株価6.5%高 薬候補で毒性試験成功 - 日本経済新聞". 日本経済新聞 電子版. 日本経済新聞社. 2024-04-17. Retrieved 2024-09-17.
  14. ^ 日経バイオテクONLINE (2024-09-02). "ネクセラファーマ、統合失調症治療薬候補 NBI-1117568の第II相臨床試験の良好な結果によりニューロクライン社より35百万米ドルのマイルストンを受領". 日経バイオテクONLINE. 日本経済新聞社. Retrieved 2024-09-17.
  15. ^ "ネクセラ---大幅反落、ニューロクラインの株価下落に追随売り | 個別株 - 株探ニュース". kabutan.jp. MINKABU THE INFONOID, Inc. 2024-08-29. Retrieved 2024-09-17.
  16. ^ "Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1117568 in Adults with Schizophrenia". ニューロクライン. 2022-10-27. Retrieved 2024-09-17.
  17. ^ a b "ネクセラファーマ[4565]：ニューロクライン社との提携プログラムである統合失調症治療薬候補NBI-1117568の第2相臨床試験で良好な結果 2024年8月28日(適時開示) ：日経会社情報DIGITAL：日本経済新聞". 日本経済新聞 電子版. 日本経済新聞社. Retrieved 2024-09-17.
  18. ^ "Nxera Pharma Official IR Blog 「ニューロクライン社から35百万米ドルのマイルストン受領」". soseiheptares.blogspot.com. ネクセラファーマ. 2024-09-02. Retrieved 2024-09-19.
  19. ^ "Neurocrine Stock Down 19% on Mixed Schizophrenia Study Results". Zacks Investment Research. Zacks Investment. 2024-08-29. Retrieved 2024-09-17.
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