Abstract Details

Title A Study of NE3107 (Bezisterim) in Early Parkinson’s Disease (SUNRISE-PD): Baseline Demographics and Characteristics

Topic Movement Disorders

Presentation(s) P6 - Poster Session 6 (5:00 PM-6:00 PM)

Poster/Presentation
Number 17-017

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

A critical step in developing new treatments for PD is analyzing trends in demographics and disease characteristics among various patient populations, which is the aim of this descriptive study on the currently enrolled SUNRISE-PD patients. Upon study completion, SUNRISE-PD is expected to provide important data on the benefits of bezisterim in patients with early PD, laying the foundation for a study of potential disease-modifying activity.

Authors/Disclosures
Joseph M. Palumbo, MD (BioVie) PRESENTER	Dr. Palumbo has received personal compensation for serving as an employee of BioVie. An immediate family member of Dr. Palumbo has received personal compensation for serving as an employee of Merck Research Laboratories. Dr. Palumbo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Stalicla SA. Dr. Palumbo has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Psychae Therapeutics Pty Ltd. Dr. Palumbo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Phocus Pharmaceuticals Inc.. Dr. Palumbo has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for BioVie. Dr. Palumbo has or had stock in BioVie. An immediate family member of Dr. Palumbo has or had stock in Merck Research Laboratories. The institution of Dr. Palumbo has received research support from United States Department of Defense. Dr. Palumbo has received intellectual property interests from a discovery or technology relating to health care. Dr. Palumbo has received intellectual property interests from a discovery or technology relating to health care. Dr. Palumbo has received intellectual property interests from a discovery or technology relating to health care.
Clarence Ahlem, MS	Mr. Ahlem has received personal compensation for serving as an employee of BioVie Inc. Mr. Ahlem has stock in BioVie Inc.. Mr. Ahlem has received intellectual property interests from a discovery or technology relating to health care.
Chris Reading, PhD	Dr. Reading has received personal compensation for serving as an employee of BioVie Inc.. Dr. Reading has stock in BioVie Inc. Dr. Reading has received intellectual property interests from a discovery or technology relating to health care.
Jeffrey Zhang (Princeton Pharmatech LLC.)	The institution of Jeffrey Zhang has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BioVie.
Mark Stacy, MD (MUSC Department of Neurology)	Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biovie. Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for National Institute of Aging. Dr. Stacy has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Dartmouth. Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Movement Disorders Journal.