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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
Triolex (bezisterim)
i
Other names: NE3107, HE 3286, HE3286
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News alerts, weekly reports and conference planners
Company:
BioVie, Harbor Biosci
Drug class:
ERK inhibitor, NF-κB inhibitor, TLR4 antagonist
Related drugs:
6ms
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
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TNFA (Tumor Necrosis Factor-Alpha) • APOE (Apolipoprotein E) • CRP (C-reactive protein) • GFAP (Glial Fibrillary Acidic Protein) • LEP (Leptin)
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Triolex (bezisterim)
6ms
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
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CRP (C-reactive protein)
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Triolex (bezisterim)
1year
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
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TNFA (Tumor Necrosis Factor-Alpha)
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Triolex (bezisterim)
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