Biovie Inc. · NASDAQ:BIVI
Biovie — 2022 Clinical Trials on Alzheimer's Disease (CTAD) Conference
16 slides from Biovie's conference presentation, Dec 2, 2022
Slide 1: Neuroimaging Data From a Phase 2, Open-Label Study of NE3107
Neuroimaging Data From a Phase 2, Open-Label Study of NE3107 in Patients With Cognitive Decline Due to Degenerative Dementias Kaya Jordan1; Kennedy Mahdavi1,2; Jonathan Haroon1; Elisabeth Rindner1; Margaret Zielinski1; Victoria Venkatraman1,2; Sergio Becerra2; Dayan Goodenowe3; Clarence Ahlem4; Chri
Slide 2: Disclosures
Disclosures KJ, KM, JH, ER, MZ, VV, SB, and SJ have received grant support from BioVie Inc. DG and BP have nothing to disclose CA, CR, and JP are employees of BioVie Inc. 2
Slide 3: Background
Background NE3107 can downregulate multiple players in the AD pathophysiology1,2 NE3107 MAPK IL-1β Chronic Aβ TNF-α TNFR1 ERK NF-κB TNF-α inflammation Immune cell Pro-inflammatory Insulin activation cytokines resistance Neurodegeneration For details, see Jung et al, 20191 and Reading et al, 20212 •
Slide 4: Hypothesis-Driven Study
Hypothesis-Driven Study Proposed Reduced neuroinflammation via a reduction of key mechanism of action inflammatory mediators, such as TNF-α Improvements in insulin signaling Reduction of AD biomarkers Proposed clinical Increase in brain glutathione, a neuroprotective antioxidant effects of NE3107 Im
Slide 5: Objectives
Objectives • A phase 2, open-label study to evaluate the potential efficacy of NE3107 in patients with mild cognitive impairment (MCI) or mild dementia using advanced neuroimaging endpoints, AD and inflammatory biomarkers, changes in glucose metabolism, and cognitive performance testing To evaluate
Slide 6: Study Design
Study Design Phase 2 Open-Label Single-Arm 3-Month Study Inclusion criteria •50-89 years old •Cognitive decline due to dementia •QDRS score: 1.5-12.5 •CDR score: 0.5 (MCI) or 1 (mild dementia) Active Treatment, 3 Months Exclusion criteria •Prior imaging inconsistent with AD NE3107 BID •History of st
Slide 7: Baseline Characteristics
Baseline Characteristics Characteristic All patients (N=23) Age, mean (SD) 71.1 (9.50) Gender, n (%) Female 16 (70) Male 7 (30) Family history, n (%) AD 5 (22) AD, dementia, unspecified etiology 2 (9) AD, PD 1 (4) Dementia, unspecified etiology 4 (17) PD 1 (4) QDRS score, mean 5.07 CDR score, n (%)
Slide 8: Clinical Assessment Outcomes
Clinical Assessment Outcomes NE3107 Was Associated With Improvements From Baseline in Clinical Outcomes of Neuropsychological and Cognitive Assessments after 3 months of Treatment Changes from Baseline in Clinical Assessments Clinician-Rated Global Rating of Change All Patients MCI/Mild AD All patie
Slide 9: Biomarkers
Biomarkers NE3107 Was Associated With Reduction in Neuroinflammation as Assessed by TNF-α Levels, Improvements in Biomarkers, and Correlations Between Biomarkers and Clinical Outcomes Correlations between biomarkers and Changes from baseline in biomarkers clinical outcomes All MMSE ≥20 All Patients
Slide 10: Neuroimaging Methodology
Neuroimaging Methodology Clinician Blinded Review Methods: Functional MRI data were submitted to blinded review and scoring by two independent clinician-readers. Inter-rater reliability was 96%; in the event of disagreement between raters, the data were subjected to additional review and ultimately
Slide 11: Neuroimaging Methodology
Neuroimaging Methodology Criteria for Abnormality: A cluster >1 cm3 shown on a statistical map would be scored as abnormal for the following connectivity patterns: For a seed placed in the Nucleus Basalis of Meynert (NBM), abnormal For a seed placed in the hippocampus (HC), abnormal regions for clus
Slide 12: Oxidative Stress
Oxidative Stress NE3107 May Be Associated With Reduced Oxidative Stress in the Brain % change from baseline in brain glutathione assessed by MRS of precuneus Precuneous Glutathione MCI/Mild AD 400 % change from baseline 300 200 100 0 -100 For all patients, there were significant correlations between
Slide 13: Functional Connectivity
Functional Connectivity NE3107 Was Associated With Increased Functional Connectivity from Baseline in Group Analysis Using BOLD Imaging Default mode network Statistically significant regions of increased connectivity 3.1 Z-score 7 Right and left hippocampus ROI (memory and learning) 3.1 Z-score 7 13
Slide 14: Neurocognition
Neurocognition Changes from baseline in ADCOMS for patients who had abnormal MRI signals at baseline and improved after treatment with NE3107 ADCOMS MCI/Mild AD Any Imaging MCI/Mild AD Temporal Parietal Occipital CBF 0.2 0.0 0.8 ADCOMS Change ADCOMS Change 0.1 −0.1 0.0 −0.1 −0.2 −0.2 0.6 −0.3 −0.3 M
Slide 15: Conclusion
Conclusion Next Steps • In this open-label study, NE3107 appeared to be associated with improvements in cognitive assessments and biomarkers related to • Subsequent longer-term, neuroinflammation and AD placebo-controlled studies are required to assess the potential • NE3107 was also descriptively a
Slide 16: Acknowledgments and References
Acknowledgments and References Acknowledgments We thank Jean R. Surya for his contribution to the data analysis of this project. p-value communications provided editorial support. Funded by BioVie Inc. References 1. Jung YJ, et al. Neuroinflammation as a factor of neurodegenerative disease: thalidom
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