Biovie Inc. · NASDAQ:BIVI
Biovie — 2024 International Conference on Alzheimer's and Parkinson's Diseases and Related Neurolog
14 slides from Biovie's conference presentation, March 2024
Slide 1: Improvement of Non-Motor Symptoms With NE3107 Adjunctive to Carbidopa/Levodopa in Parkinson's Disease
IMPROVEMENT OF NON-MOTOR SYMPTOMS WITH NE3107 ADJUNCTIVE TO CARBIDOPA/LEVODOPA IN PATIENTS WITH PARKINSON’S DISEASE: A PHASE 2A, PLACEBO-CONTROLLED STUDY Joseph Palumbo1; Christopher L. Reading1; Clarence Ahlem1; Nily Osman2; Jeffrey Zhang1,3; Jason L. Aldred4; Ramon L. Rodriguez5; Edgardo J. Rivera
Slide 2: Disclosures
Disclosures CLR, CA, and JP are employees of BioVie Inc. NO is formerly an employee of BioVie Inc. JZ is a consultant for BioVie Inc. SHI and AEL have served as advisors for Biovie Inc. RLR and RK have received grants from BioVie Inc. Acknowledgments p-value communications provided editorial support
Slide 3: Background
Background NE3107 is hypothesized to disrupt PD pathogenesis via its anti-inflammatory and insulin-sensitizing actions NE3107 MAPK IL-1β Chronic TNF-α TNFR1 NF-κB ERK TNF-α inflammation Stimuli Activated Pro-inflammatory cytokines Insulin Up to (eg, α-synuclein) microglia resistance ~60% Mitochondri
Slide 4: Study Design: Phase 2, Double-Blind, Placebo-Controlled, 28-Day Duration
Study Design: Phase 2, Double-Blind, Placebo-Controlled, 28-Day Duration Inclusion criteria • 30-80 years old NE3107 20 mg + IR C/L • Diagnosis of PD BID 12 hours apart • Bradykinesia and motor response to 1:1 Active Treatment, 27 days levodopa Safety follow-up • History of motor fluctuations + Day
Slide 5: Baseline Characteristics
Baseline Characteristics Characteristic NE3107 + IR C/L (n=24) Placebo + IR C/L (n=22) Age, mean (y) 67.4 65.8 Gender, n (%) Female 10 (41.7) 8 (36.4) Male 14 (58.3) 14 (63.6) Weight, mean (kg) 80.1 80.8 BMI, mean 27.6 26.4 Time since diagnosis, mean (years) 7.6 7.2 Total daily levodopa, mean (mg) 5
Slide 6: MDS-UPDRS Part III Score
NE3107 treatment was associated with clinically meaningful and superior improvements (3+ points) on the motor examination part (Part III) of the MDS- UPDRS, with greatest improvement in patients <70 years old (~6+ points ) Day 28 improvement in motor control vs day 1 0 All Patients Patients <70 year
Slide 7: More NE3107-levodopa treated patients experienced morning ON state on day 28
More NE3107-levodopa combination treated patients who experienced an “OFF” state at baseline experienced a morning “ON” state prior to dosing on day 28 Post Hoc Efficacy Assessment 0 (0%) 6 (30%) "OFF" state "OFF" state "ON" state "ON" state 14 (70%) 19 (100%) P=0.02 • 30% (6/20) of patients treated
Slide 8: Significant Improvement in the NMSS Sleep/Fatigue Domain Score
Significant Improvement in the NMSS Sleep/Fatigue Domain Score Improvements were correlated with Motor Score improvements P=0.0159b 2 Cohen’s d = -0.5 Change From Baseline in NMSS Total Scorea 1.0 1 NE3107 (n=20c) 0 Placebo (n=17c) Improvement −1 −2 −2.4 −3 Sleep/fatigue domain improvements signific
Slide 9: More Patients on NE3107 Had Improvements in NMSS Sleep/Fatigue Domain
More Patients on NE3107 had Improvements in the NMSS Sleep/Fatigue Domain, While More Patients on Placebo Worsened Treatment arm Placebo 400 NE3107 % Change From Baseline in NMSS Domain 2 Score Worsening 200 0 Improvement −200 −400 Per Protocol population: patients with baseline and Visit 6 evaluabl
Slide 10: Changes Driven by Improvement in Fatigue (Q4) and Restless Legs (Q6)
The Changed in the NMSS Sleep/Fatigue Domain Score Were Driven by Improvement in Fatigue/Lack of Energy (Q4) and Urge to Move Legs/Restlessness in Legs (Q6) Per Protocol population – patients with baseline and Visit 6 evaluable data Q3: Does the patient doze off or fall asleep unintentionally during
Slide 11: Significant Improvement From Baseline in Fatigue/Lack of Energy (Q4)
Significant Improvement From Baseline in Fatigue/Lack of Energy (Q4) Achieved With NE3107 but Not Placebo Does fatigue (tiredness) or lack of energy (not slowness) limit the patient’s daytime activities? All Patients Patients with Symptoms at Baseline NE3107 Placebo NE3107 Placebo (n=20b) (n=17b) (n
Slide 12: Significant Improvement in Urge to Move Legs/Restlessness in Legs (Q6)
Significant Improvement From Baseline in Urge to Move Legs/Restlessness in Legs (Q6) Achieved With NE3107 but Not Placebo Does the patient experience an urge to move the legs or restlessness in legs that improves with movement when he/she is sitting or lying down inactive? All Patients Patients with
Slide 13: Conclusions
Conclusions • These data suggest that as adjunct therapy to levodopa, NE3107 may hold promise in ameliorating specific non-motor symptoms of PD, particularly in sleep/fatigue items of domain 2 of the NMSS assessment scale related to fatigue/lack of energy and restlessness of the legs • These finding
Slide 14: References
References 1. Troncoso-Escudero P, Parra A, Nassif M, Vidal RL. Outside in: unraveling the role of neuroinflammation in the progression of Parkinson’s disease. Front Neurol. 2018;9:860. doi: 10.3389/fneur.2018.00860 2. Athauda D, Foltynie T. Insulin resistance and Parkinson’s disease: a new target f