BioVie reported positive Phase 2 SUNRISE-PD results showing bezisterim improved motor and non-motor symptoms, reduced neuroinflammation biomarkers, and demonstrated favorable safety in early Parkinson’s disease.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
BioVie Inc. reported positive topline results from the Phase 2b SUNRISE-PD trial, showing that its investigational oral therapy bezisterim (NE3107) improved biological markers of inflammation while producing clinically meaningful benefits across motor and non-motor symptoms in patients with early Parkinson’s disease (PD). The randomized, double-blind, placebo-controlled study also demonstrated a favorable safety profile, providing proof-of-mechanism and proof-of-concept for the therapy in patients who had not previously received carbidopa/levodopa.
Targeting Neuroinflammation in Early Parkinson’s Disease
Parkinson’s disease affects more than 10 million people worldwide and is characterized not only by progressive motor impairment but also by disabling non-motor symptoms, including sleep disturbances, fatigue, cognitive dysfunction, depression, and autonomic abnormalities. Growing evidence suggests chronic neuroinflammation contributes to disease progression, creating interest in therapies that address underlying biology rather than symptomatic dopamine replacement alone.
Bezisterim is an investigational oral small molecule that crosses the blood-brain barrier and modulates inflammatory pathways involving ERK, NF-κB, and TNF-α while improving insulin sensitivity without broadly suppressing the immune system.
Phase 2 Trial Demonstrated Broad Clinical and Biomarker Benefits
SUNRISE-PD (NCT06757010) enrolled 57 patients with early-stage Parkinson’s disease who had not previously received dopaminergic therapy. Participants were randomized 1:1 to receive bezisterim 20 mg twice daily or placebo for 12 weeks.
The study met its predefined pharmacodynamic objectives, demonstrating reductions in blood-based inflammatory biomarkers together with improvements in multiple clinical outcome measures.
Patients receiving bezisterim showed statistically significant improvements versus placebo across MDS-UPDRS Parts I, II, and III, reflecting benefits in non-motor symptoms, activities of daily living, and motor function. The treatment also significantly improved the EPNIC-15 composite endpoint, which integrates 15 clinically relevant motor and non-motor measures (p=0.0006).
Clinical benefits appeared strongest among participants with higher baseline platelet counts, a marker associated with inflammatory status. In patients with platelet counts above 230 × 10³/µL, bezisterim demonstrated statistically significant advantages across every major clinical assessment, suggesting inflammatory biomarkers may help enrich future Phase 3 enrollment rather than exclude patients.
Beyond clinical outcomes, bezisterim significantly reduced biomarkers linked to neuroinflammation, including CCL2, CHI3L1, and VGF, while also lowering systemic inflammatory markers such as IL-6, IL-17A, TNF-α, interferon-γ, monocyte-to-lymphocyte ratio, and the Systemic Inflammation Response Index. The composite neuroinflammation score improved significantly compared with placebo (p=0.0018).
Proteomic analyses further supported biological activity, with 283 of 380 measured proteins shifting toward a lower inflammatory profile, suggesting broad modulation of pathways associated with Parkinson’s disease progression.
Exploratory analyses also showed favorable changes in biomarkers associated with neuronal injury, including neurofilament light chain (NfL), GFAP, UCHL1, and MAPT, with significant reductions in the composite neuronal injury signal and NfL compared with placebo.
Favorable Safety Profile Supports Continued Development
Bezisterim was well tolerated throughout the study. Adverse events occurred in 39.3% of patients receiving bezisterim compared with 51.7% in the placebo group. No severe or serious adverse events were reported, and only one treatment-related adverse event occurred in each treatment arm. Most reported events were mild.
BioVie President and Chief Executive Officer Cuong Do said the results support bezisterim’s potential to improve both motor and non-motor manifestations of Parkinson’s disease while targeting biological pathways associated with disease progression. Chief Medical Officer Joseph M. Palumbo, MD, added that the combined clinical, biomarker, proteomic, and safety findings strengthen confidence in advancing the program.
Path Forward
The SUNRISE-PD results will guide the design of a potentially registrational Phase 3 trial, including evaluation of inflammatory biomarkers that may identify patients most likely to benefit from therapy. BioVie plans to present the full dataset at a future medical meeting and will host a conference call on August 12, 2026, to discuss the findings. Meanwhile, the company continues clinical development of bezisterim in Long COVID, with topline results from the Phase 2 ADDRESS-LC study expected later this summer.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.