BioVie (BIVI) Status Update summary

Overview of Parkinson's disease and unmet needs

• Parkinson's disease is characterized by motor dysfunction due to loss of pigmented neurons and accumulation of Lewy bodies, with neuroinflammation and oxidative stress as key drivers of neurodegeneration.

• Current treatments focus on symptom management and do not address underlying neurodegenerative processes; anti-inflammatory approaches are not yet established as disease-modifying.

• Non-motor symptoms and overlap with other neurodegenerative diseases complicate diagnosis and management.

Bezisterim mechanism and preclinical data

• Bezisterim is an orally bioavailable anti-inflammatory agent that targets the ERK/NF-kappa B pathway, reducing inflammatory cytokine production without disrupting homeostasis.

• Demonstrated neuroprotective and promotoric effects in animal models and improved motor and non-motor symptoms in prior phase II studies.

• Preclinical models show preservation of neurons and reduction of TNF activity, supporting potential disease-modifying effects.

Sunrise PD clinical trial design

• Sunrise PD is a phase II, double-blind, randomized controlled trial enrolling early-stage, mostly drug-naïve Parkinson's patients.

• The trial uses both traditional and home-based assessments, with video ratings by trained specialists to ensure consistency and accessibility.

• Primary endpoint is change in MDS UPDRS part 3 (motor scale), with secondary and exploratory endpoints including non-motor symptoms, sleep, and DNA methylation biomarkers.