Biovie Inc. · NASDAQ:BIVI
Biovie — Technical Presentation (June 2023)
9 slides from Biovie's technical presentation, Jun 23, 2023
Slide 1: Metabolic Dysregulation in Probable Alzheimer's Disease
Metabolic Dysregulation in Probable Alzheimer’s Disease Christopher L. Reading1, Clarence Ahlem1, Joseph M. Palumbo1, Marcia A. Testa2, Donald C. Simonson3 1BioVie Inc., Carson City, Nevada, USA; 2Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA; 3Di
Slide 2: Disclosures
Disclosures Funded by BioVie Inc. MAT has received grant support from BioVie Inc. CLR, CA, and JMP are employees of BioVie Inc. DCS has nothing to disclose. 1
Slide 3: Background
Background • Alzheimer’s disease (AD) is a multifactorial disease1, and several risk factors, such as obesity, chronic inflammation, insulin resistance (IR), oxidative stress, and dyslipidemia, may contribute to neurodegeneration, AD progression, and subsequent cognitive decline2 – Obesity is associ
Slide 4: Study endpoints
Study endpoints Efficacy assessments: Primary endpoints – change from baseline to treatment completion (week 30) • Cognitive impairment: CDR-SB Secondary endpoints – change from baseline to treatment completion (week 30) • Neurocognitive functioning: ADAS-Cog12, MMSE, ADCOMS, and CDR • Global assess
Slide 5: Study design
Study design • This is a phase 3, double-blind, placebo-controlled, parallel group, multicenter 40-week study of bezisterim to evaluate the safety, tolerability, and efficacy of oral bezisterim administered twice daily (BID; approximately 12 hours apart) in patients with mild to moderate probable AD
Slide 6: Results: baseline characteristics
Results Most patients had Baseline characteristics abdominal obesity (see Table 1) 378 Patients 73 55 % 45 85% Patients had enrolled Patients had inflammation, hyperglycemia and Mean age High WHR hypertension, and insulin resistance dyslipidemia 32% 20% 61% 13% 112 15% 47% 70 85% 32% 30% 40% mg/dL m
Slide 7: Table 1. Baseline characteristics
Table 1. Baseline characteristics All Aβ+a Aβ−b APOE ε4+ APOE ε4− Characteristic P P N=378 n=57 n=77 n=97 n=259 Age, mean (SE) y 73 (0.3) 76 (0.8) 72 (0.6) ** 73 (0.6) 73 (0.4) - Female, % 55 53 67 - 64 64 - High WHRc, % 85 84 84 - 81 82 - FPG, mean, mg/dL 112 100 112 * 106 115 * IFG, % 32 18 35 # 2
Slide 8: Conclusions
Conclusions • This is the largest study to date to evaluate the safety and efficacy of bezisterim in patients with AD; bezisterim is the only anti- inflammatory agent currently in phase 3 development for AD11 • At baseline, the majority of patients had a high WHR (85%), hypertension (61%), and impai
Slide 9: References
References 1. Iqbal K, Grundke-Iqbal I. Alzheimer's disease, a multifactorial disorder seeking multitherapies. Alzheimers Dement. 2010;6(5):420-424. 2. Verdile G, Keane KN, Cruzat VF, et al. Inflammation and oxidative stress: the molecular connectivity between insulin resistance, obesity, and Alzhei