SUNRISE-PD
(2026)Objective
Evaluate whether bezisterim reduces systemic/neuro-inflammation and improves motor and non-motor measures in early, levodopa-naïve Parkinson's disease.
Study Summary
• PRIMARY endpoint was PHARMACODYNAMIC (hematologic inflammatory indices — NLR, MLR, SIRI, SII, PLR, AISI + composite) and was MET — i.e., an anti-inflammatory mechanism readout, not a clinical-efficacy endpoint.
• Exploratory clinical composite EPNIC-15 favored bezisterim (−0.04 vs +0.18; Cohen's d −0.94; p=0.0006); MDS-UPDRS Parts I–III improved, most in the ~50% with baseline platelets >230×10³/µL.
• Neurofilament light (NfL) rise slowed (p=0.008); Aβ42 (p=0.09) and pTau-217 (p=0.13) only trends; broad anti-inflammatory proteomic shift (283/380 proteins).
• Well tolerated — AEs 39.3% vs 51.7% placebo, no serious AEs. A platelet-enriched, potentially pivotal Phase 3 is planned.
⚠ Company topline press release — not peer-reviewed.
Intervention
Bezisterim 20 mg orally twice daily vs matching placebo for 12 weeks.
Inclusion Criteria
Early-stage Parkinson's disease; naïve to carbidopa/levodopa.
Study Design
Arms: Bezisterim 20 mg BID; matching placebo
Patients per Arm: 57 total, randomized 1:1
Outcome
Bottom Line
Bezisterim met its pharmacodynamic (anti-inflammatory biomarker) primary endpoint and showed exploratory clinical and neurodegeneration-biomarker signals (EPNIC-15 p=0.0006; slowed NfL p=0.008) in early levodopa-naïve PD, with placebo-like tolerability. Encouraging but early: clinical efficacy is exploratory in a small 12-week study, and the responder finding (platelets >230k) is a post-hoc enrichment. Topline press-release data.
Major Points
- Primary endpoint was an inflammatory-biomarker (pharmacodynamic) composite — MET; clinical outcomes were secondary/exploratory.
- EPNIC-15 exploratory clinical composite favored bezisterim (Cohen's d −0.94, p=0.0006).
- MDS-UPDRS Parts I, II, III improved, most in the ~50% with baseline platelets >230×10³/µL.
- NfL rise slowed (−0.0148 vs +0.0095 log2/week; p=0.008); Aβ42 and pTau-217 only trends.
- Safety comparable to placebo (AEs 39.3% vs 51.7%; no SAEs). Phase 3 with platelet enrichment planned.
Study Design
- Study Type
- Phase 2b, randomized, double-blind, placebo-controlled
- Randomization
- Yes
- Blinding
- Double-blind, matching placebo
Primary Outcome
Definition: Change in hematologic inflammatory indices (NLR, MLR, SIRI, SII, PLR, AISI) and composite
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - | - | - | - |
Limitations & Criticisms
- Primary endpoint was a pharmacodynamic biomarker, not a clinical outcome.
- Small sample (n=57) and short (12-week) duration.
- Clinical benefits (EPNIC-15, MDS-UPDRS) were secondary/exploratory; EPNIC-15 is a novel composite.
- High-platelet responder subgroup is a post-hoc enrichment signal.
- Company topline press release — not peer-reviewed; full data pending.
Citation
BioVie Inc. Topline Results of Phase 2 SUNRISE-PD Trial of Bezisterim in Early Parkinson's Disease. Press release, 2026.