A Study of NE3107 in Early Parkinson's (SUNRISE-PD)

A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease

The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in generally good physical and mental health, and are nearing the need for treatment to relieve their symptoms but have not yet been prescribed any form of levodopa or drug with similar activity. The main questions it aims to answer are:

• Will bezisterim decrease movement symptoms of Parkinson's disease?
• What medical problems do participants have when taking bezisterim?

Researchers will compare the effects of bezisterim treatment to placebo (a look-alike substance that contains no drug) to see if bezisterim works to treat movement symptoms of Parkinson's disease.

Participants will

• have a physical examination that includes an electrocardiogram
• take drug or placebo twice daily for four months
• visit a clinical site or receive an at home visit seven times over the course of five months

Study Overview

• Status: Completed
• Conditions: Parkinsons Disease (PD)
• Intervention / Treatment: Drug: Placebo; Drug: NE3107

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Science 37 (Nationwide Site)
  • Ohio
    • Canton, Ohio, United States, 44718
      • Neuroscience Research Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 45 years to 80 years of age
• diagnosed with idiopathic Parkinson's Disease (PD) within 18 months
• nearing the need for symptomatic therapy
• agree to use birth control measures
• provide voluntary consent
• willing to allow blood collection for DNA methylation analysis
• pass all screening tests and procedures

Exclusion Criteria:

• has taken levodopa or another similar drug for the motor symptoms of PD
• a known or strongly suspected familial cause for PD diagnosis
• major mental health or physical illness
• medical history of major mental or physical illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NE3107; Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules.	Drug: NE3107; NE3107 20 mg BID; Other Names: bezisterim
Placebo Comparator: Placebo; Subjects will receive matching placebo capsules for oral administration BID (twice daily).	Drug: Placebo; Placebo BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocyte Lymphocyte Ratio (MLR)	A unitless inflammatory biomarker calculated by dividing the absolute peripheral blood monocyte count by the absolute peripheral blood lymphocyte count, using values derived from clinical hematology (complete blood count with differential)	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systemic Inflammation Response Index (SIRI)	A unitless measure of systemic inflammation calculated as the product of the absolute blood neutrophil count and absolute blood monocyte count divided by the absolute blood lymphocyte count in samples obtained for clinical hematology testing.	12 weeks
Change in Neutrophil-to-Lymphocyte Ratio (NLR)	A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood neutrophil count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.	12 weeks
Change in Systemic Immune-Inflammation Index (SII)	A unitless composite measure of systemic inflammation and immune status calculated as the product of the absolute peripheral blood platelet count and neutrophil count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.	12 weeks
Change in Platelet-to-Lymphocyte Ratio (PLR)	A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood platelet count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.	12 weeks
Change in Aggregate Index of Systemic Inflammation (AISI)	A unitless composite measure of systemic inflammation calculated as the product of the absolute peripheral blood neutrophil count, monocyte count, and platelet count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.	12 weeks
Change in the Composite Benefit Score (CBS)	Early Parkinson's Neuro-Inflammatory Composite-15 (EPNIC-15), a composite endpoint consisting of 15 clinically relevant motor and non-motor measures derived from MDS-UPDRS Parts I, II, and III and PDSS-2 assessments. Lower scores indicate improvement in Parkinson's disease symptoms.	12 weeks
Change in MDS-UPDRS modified Part III	Change from baseline in MDS-UPDRS Modified Part III score, a clinician-rated measure of Parkinson's disease motor signs assessed using a modified Part III examination. The scale evaluates motor manifestations including speech, tremor, rigidity, bradykinesia, gait, posture, and postural stability. Higher scores indicate worse motor impairment.	12 weeks
Change in MDS-UPDRS Part II scores	Change from baseline in MDS-UPDRS Part II score. MDS-UPDRS Part II assesses the impact of Parkinson's disease motor symptoms on activities of daily living, with higher scores indicating greater impairment and negative changes indicating improvement.	12 weeks
Change in MDS-UPDRS Part I scores	Change from baseline in MDS-UPDRS Part I score. MDS-UPDRS Part I assesses non-motor experiences of daily living in Parkinson's disease, with higher scores indicating greater symptom burden and negative changes indicating improvement.	12 weeks
Change in MDS-UPDRS combined scores	Change from baseline in the combined MDS-UPDRS score (Parts I + II + III). The combined score assesses overall Parkinson's disease burden across non-motor symptoms, activities of daily living, and motor signs, with higher scores indicating greater impairment and negative changes indicating improvement.	12 weeks
Change in PDQ-39 score	Change from baseline in PDQ-39 total score. The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life across eight domains affected by Parkinson's disease. Higher scores indicate worse quality of life and negative changes indicate improvement.	12 weeks
Clinician's General Impression of Improvement (CGI-I)	Clinician's Global Impression of Improvement (CGI-I) score. The CGI-I is a clinician-rated measure of overall change in a participant's condition compared with baseline, scored on a 7-point scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement.	12 weeks
Clinician's General Impression of Severity (CGI-S)	Change from baseline in Clinician's Global Impression of Severity (CGI-S) score. The CGI-S is a clinician-rated measure of overall illness severity scored on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater severity and negative changes indicate improvement.	12 weeks
Change in PARCOMS-Motor (modified to adjust for missing MDS-UPDRS Part III scores)	Change from baseline in modified PARCOMS-Motor score. PARCOMS-Motor is a composite measure of Parkinson's disease motor symptoms derived from MDS-UPDRS motor assessments. The score was modified to adjust for missing MDS-UPDRS Part III data. Higher scores indicate greater motor impairment and negative changes indicate improvement	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PDSS-2	Change from baseline in PDSS-2 total score. The Parkinson's Disease Sleep Scale-2 (PDSS-2) assesses sleep disturbances and nocturnal symptoms associated with Parkinson's disease. Higher scores indicate worse sleep impairment and negative changes indicate improvement.	12 weeks
Change in DNA methylation	Change from baseline in DNA methylation levels measured in peripheral blood samples. DNA methylation is an epigenetic biomarker associated with regulation of gene expression and cellular function.	12 weeks
Percent change in hematologic inflammatory biomarker indices	Percent change from baseline in hematologic inflammatory biomarker indices (MLR, NLR, PLR, SIRI, SII, and AISI) derived from routine hematology testing. These indices are calculated from peripheral blood cell counts and are used as measures of systemic inflammation.	12 weeks
Change in plasma biomarkers of inflammation	Change from baseline in plasma biomarkers of inflammation measured in peripheral blood samples. Plasma inflammatory biomarkers are indicators of immune and inflammatory activity that may reflect biological responses to treatment.	12 week
Interaction between baseline inflammation level and treatment effect on changes in circulating inflammatory indices	Interaction between baseline inflammation level and treatment effect on changes in circulating inflammatory indices. Analysis of whether treatment effects on MLR, NLR, PLR, SIRI, SII, and AISI vary according to baseline systemic inflammation status.	12 weeks
Interaction between baseline inflammation level and treatment effect on changes in clinical endpoints	Interaction between baseline inflammation level and treatment effect on changes in clinical endpoints. Analysis of whether treatment effects on clinical measures vary according to baseline systemic inflammation status.	12 weeks
Interaction between change in inflammation level and treatment effect on changes in circulating inflammatory indices	Relationship between change in inflammation level and change from baseline in circulating inflammatory indices (MLR, NLR, PLR, SIRI, SII, and AISI). Analysis of whether treatment-related changes in systemic inflammation are associated with changes in circulating inflammatory biomarkers.	12 week
Interaction between change in inflammation level and treatment effect on changes in clinical endpoints	Relationship between change in inflammation level and change from baseline in clinical endpoints. Analysis of whether treatment-related changes in systemic inflammation are associated with changes in clinical measures of Parkinson's disease.	12 weeks
Percent of subjects with any improvement from baseline as measured by CGI-I	Percent of participants with improvement on CGI-I. Improvement is defined as a CGI-I score of 1 (very much improved), 2 (much improved), or 3 (minimally improved). The CGI-I is a clinician-rated measure of overall change from baseline	12 weeks
Percent of subjects with any improvement from baseline as measured by CGI-S	Percent of participants with improvement in CGI-S score from baseline. Improvement is defined as any decrease from baseline in the Clinician's Global Impression of Severity (CGI-S) score. The CGI-S is a clinician-rated measure of overall illness severity scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Lower scores indicate less severe illness.	12 weeks
Biological and disease phenotype subgroup analyses for changes in circulating inflammatory biomarker indices	Biological and disease phenotype subgroup analyses of changes in circulating inflammatory biomarker indices (MLR, NLR, PLR, SIRI, SII, and AISI). Analyses will evaluate whether treatment-related changes in inflammatory biomarkers differ across predefined biological and disease phenotype subgroups.	12 weeks
Biological and disease phenotype subgroup for changes in clinical endpoints	Biological and disease phenotype subgroup analyses of changes in clinical endpoints. Analyses will evaluate whether treatment-related changes in clinical outcome measures differ across predefined biological and disease phenotype subgroups.	12 weeks

Collaborators and Investigators

• Sponsor: BioVie Inc.

Publications and helpful links

Helpful Links

• www.SunrisePD.com

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Actual): May 1, 2026
• Study Completion (Actual): May 31, 2026

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Treatment naïve Parkinson's; Early Parkinson's
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: NE3107-PD-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No