Objective:

This report captures the baseline characteristics of participants in SUNRISE-PD, which is designed to evaluate the safety and efficacy of bezisterim for the treatment of motor and non-motor symptoms of early Parkinson’s disease (PD).  

Background:

Chronic neuroinflammation, insulin resistance, and oxidative stress contribute to the progression of PD. Bezisterim (NE3107), an oral, blood-brain barrier–permeable, anti-inflammatory agent, has demonstrated improvement in both motor and non-motor symptoms in patients with PD via purported nuclear factor kappa B and tumor necrosis factor alpha signal disruption.

Design/Methods:

This ongoing, phase 2, double-blind, placebo-controlled study (NCT06757010) is randomizing eligible adults (aged 45-80 years) to a 16-week treatment period (twice daily 20-mg bezisterim or placebo) and a 4-week follow-up period. Eligible patients include symptomatic patients diagnosed with idiopathic PD who are naïve to levodopa or similar medications. The Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) is being used to assess motor symptoms (Part III) and non-motor symptoms (Parts I and II). Additional baseline assessments include the Parkinson’s Disease Questionnaire-39 (PDQ-39), the Parkinson’s Disease Sleep Scale (PDSS), and laboratory assessments for DNA methylation and plasma biomarkers, among others.

Results:

The baseline demographics and key disease characteristics of the enrolled patient population will be presented at the congress. Data will be summarized for the overall population using descriptive statistics as appropriate for each measure presented.

Conclusions: