^
    4ms
    Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury (clinicaltrials.gov)
    P2, N=4, Terminated, Neurological Associates of West Los Angeles | The participant's caregiver requested for the participant to be withdrawn from the study. The investigator has decided to close out.
    Trial termination • Trial primary completion date
    |
    Triolex (bezisterim)
    8ms
    ADdRESs-LC: NE3107 in Adults With Long COVID (clinicaltrials.gov)
    P2, N=208, Recruiting, BioVie Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Triolex (bezisterim)
    9ms
    ADdRESs-LC: NE3107 in Adults with Long COVID (clinicaltrials.gov)
    P2, N=208, Not yet recruiting, BioVie Inc.
    New P2 trial
    |
    Triolex (bezisterim)
    10ms
    SUNRISE-PD: A Study of NE3107 in Early Parkinson's (clinicaltrials.gov)
    P2, N=60, Recruiting, BioVie Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Triolex (bezisterim)
    11ms
    SUNRISE-PD: A Study of NE3107 in Early Parkinson's (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, BioVie Inc.
    New P2 trial
    |
    Triolex (bezisterim)
    over1year
    A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias. (PubMed, Medicine (Baltimore))
    Our results indicate that in this study NE3107 was associated with what appear to be positive neurophysiological and neuropsychological findings, as well as evidence of improvement in biomarkers associated with neuroinflammation and AD in patients diagnosed with dementia. Our findings are consistent with previous preclinical and clinical observations and highlight a central role of neuroinflammation in AD pathogenesis.
    P2 data • Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    |
    Triolex (bezisterim)
    over1year
    Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury (clinicaltrials.gov)
    P2, N=5, Recruiting, Neurological Associates of West Los Angeles | Not yet recruiting --> Recruiting | Phase classification: P2a --> P2 | Trial completion date: Jul 2024 --> Jul 2025 | Initiation date: Aug 2023 --> Dec 2023 | Trial primary completion date: Jun 2024 --> Dec 2024
    Enrollment open • Phase classification • Trial completion date • Trial initiation date • Trial primary completion date
    |
    Triolex (bezisterim)
    2years
    A Phase 3 Study of NE3107 in Probable Alzheimer's Disease (clinicaltrials.gov)
    P3, N=439, Completed, BioVie Inc. | Active, not recruiting --> Completed | N=316 --> 439
    Trial completion • Enrollment change
    |
    TNFA (Tumor Necrosis Factor-Alpha) • APOE (Apolipoprotein E) • CRP (C-reactive protein) • GFAP (Glial Fibrillary Acidic Protein) • LEP (Leptin)
    |
    Triolex (bezisterim)
    2years
    Blinded response data from the phase 3 NM101 trial of anti-inflammatory bezisterim (NE3107) in patients with mild to moderate Alzheimer’s disease (Neuroscience 2023)
    These data suggest that the pathophysiology of dementia and cognitive impairment in probable AD are driven by inflammatory factors that are present in both Aβ-positive and -negative populations. Additionally, the study findings suggest that the current diagnostic criteria for AD based on Aβ status may be too stringent and may inadvertently prevent development of therapies for patients with probable AD.
    Clinical • P3 data
    |
    CRP (C-reactive protein)
    |
    Triolex (bezisterim)
    over2years
    Multi-Modal Correlation Analyses From a Phase 2, Open-Label Study of NE3107 in Patients With Cognitive Decline Due to Degenerative Dementias (AAN 2023)
    Conclusions Correlations among improved cognitive function, reduced inflammation, and changes in the clinician-observed GRC (overall impression of patient’s abilities) were consistent with the hypothesized activities of NE3107. Preliminary examination of metabolic and functional brain imaging supports hypothesis-based directional changes in accordance with the expected mechanism of action.
    Clinical • P2 data
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    |
    Triolex (bezisterim)