NSI-189

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NSI-189
Clinical data
Routes of
administration		By mouth[1]
Legal status
Legal status
Pharmacokinetic data
Elimination half-life17.4–20.5 hours[1]
Identifiers
  • (4-Benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone
JSmol)
  • CC(C)CCNC1=C(C=CC=N1)C(=O)N2CCN(CC2)CC3=CC=CC=C3
  • InChI=1S/C22H30N4O/c1-18(2)10-12-24-21-20(9-6-11-23-21)22(27)26-15-13-25(14-16-26)17-19-7-4-3-5-8-19/h3-9,11,18H,10,12-17H2,1-2H3,(H,23,24)
  • Key:DYTOQURYRYYNOR-UHFFFAOYSA-N ☒N

NSI-189 (NeuralStem Inc 189) is an

neurodegeneration.[2][1][3]

A phase II clinical trial for MDD failed to meet the primary depression endpoint (MADRSTooltip Montgomery–Åsberg Depression Rating Scale) in July 2017, although statistically significant improvements have been reported on a number of secondary depression and cognition endpoints.[4][5]

The compound's activity was discovered using

target of the compound was unknown but it appeared to promote neurogenesis in rodents.[2][3]

NSI-189 completed a

Cohen's d = 1.12, p = 0.002), working memory (d = 0.81, p = 0.020), and executive functioning (d = 0.66, p = 0.048) as measured by the CogScreen computerized test.[5]

In August 2020 another phase 2 study with 220 participants was done. An 80 mg dose of NSI-189 showed significant benefit over placebo in the subgroup of patients who were moderately depressed (MADRS < 30) but was not significant in patients who were severely depressed (MADRS ≥ 30). The study concludes that NSI-189 is effective as a safe adjunctive therapy, with most compelling antidepressant and procognitive benefits noted in patients with moderate depression.[10]

In addition to MDD, Neuralstem has said that it intends to pursue clinical development of NSI-189 for a variety of other

neurological conditions, including traumatic brain injury, Alzheimer's disease, post-traumatic stress disorder, stroke, and to prevent cognitive and memory decline in aging.[2]

In 2021, Neuralstem merged with another company to become Palisade Bio, who in 2021 sold NSI-189 to an unknown buyer for up to $4.9 million.[11]

See also

References

  1. ^
    PMID 26643541
    .
  2. ^
    ISBN 978-1-4833-4767-7
    .
  3. ^ a b c Neuralstem (March 2016), Neuralstem Inc. March 2016 Corporate Presentation (PDF), retrieved 25 March 2016[dead link] Alt URL
  4. ^ "Neuralstem: NSI-189 Phase 2 Trial Fails To Meet Primary Efficacy Endpoint". NASDAQ.com. 2017-07-25. Retrieved 2017-09-20.
  5. ^ a b "Neuralstem Inc. Corporate Presentation" (PDF). January 2018.
  6. ^ Clinical trial number NCT01310881 for "Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189" at ClinicalTrials.gov
  7. ^ Clinical trial number NCT01520649 for "Multiple-Dose Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects" at ClinicalTrials.gov
  8. ^ "Neuralstem Announces Top-line Phase 2 Data of NSI-189 for Major Depressive Disorder" (Press release). Neuralstem Inc. 25 July 2017.
  9. ^ Court E (July 25, 2017). "UPDATE: Neuralstem stock plummets 61% on news of mid-stage clinical trial miss".
  10. PMID 32722729
    .
  11. ^ "Palisade Bio, Inc. Announces Sale of Seneca Asset NSI-189 for the treatment of Central Nervous System Disorders". 22 October 2021.

External links

  • McIntyre RS, Johe K, Rong C, Lee Y (June 2017). "The neurogenic compound, NSI-189 phosphate: a novel multi-domain treatment capable of pro-cognitive and antidepressant effects". Expert Opinion on Investigational Drugs. 26 (6): 767–770.
    S2CID 205768353
    .
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