Triolex (bezisterim)

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, 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

P3, N=439, Completed, BioVie Inc. | Active, not recruiting --> Completed | N=316 --> 439

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.

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.