--- title: "BioVie reports topline results from Phase 2 SUNRISE-PD trial in Parkinson's" url: "https://aibio.space/news/biovie-reports-topline-results-phase-2-sunrise-pd-trial-parkinsons/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-08-06" section: "Company Updates" tickers: "NASDAQ:BIVI" source: "https://www.sec.gov/Archives/edgar/data/1580149/000152013826000312/bivi-20260806_8kex99z1.htm" summary: "BioVie said bezisterim met its prespecified endpoints in early-stage Parkinson's disease, with improved blood inflammatory markers and better composite cli" --- By the aibio.space news desk. Sources - [BioVie Inc. 8-K (2026-08-06)](https://www.sec.gov/Archives/edgar/data/1580149/000152013826000312/bivi-20260806_8kex99z1.htm) - [BioVie Inc. 10-K (2025-08-15): business](https://www.sec.gov/Archives/edgar/data/1580149/000152013825000268/bivi-20250630_10k.htm) [BIVI](https://aibio.space/companies/biovie/) 2026-08-06 # BioVie reports topline results from Phase 2 SUNRISE-PD trial in Parkinson's disease Tickers [BIVI](https://aibio.space/companies/biovie/) BioVie said bezisterim met its prespecified endpoints in early-stage Parkinson's disease, with improved blood inflammatory markers and better composite clinical outcomes than placebo. ## Key facts - **Company**: BioVie Inc. (NASDAQ: BIVI) - **News type**: Company Updates - **Primary source**: [BioVie Inc. 8-K (2026-08-06)](https://www.sec.gov/Archives/edgar/data/1580149/000152013826000312/bivi-20260806_8kex99z1.htm) *A researcher pipetting at a laboratory bench. Photo: usdoe, CC0, via rawpixel. The picture shows the field, not the companies named.* BioVie Inc. (NASDAQ: [BIVI](https://aibio.space/companies/biovie/)) announced on August 6, 2026 topline results from its Phase 2 SUNRISE-PD trial of bezisterim in patients with early-stage Parkinson's disease. The company said the trial met its prespecified endpoints and achieved its objectives. The results were furnished in a [Form 8-K](https://www.sec.gov/Archives/edgar/data/1580149/000152013826000312/bivi-20260806_8kex99z1.htm) filed on August 6, 2026. The release says a conference call to discuss the results is scheduled for 4:15 p.m. on August 12, 2026. ## The trial design The SUNRISE-PD trial was a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial. It was designed to establish proof-of-mechanism and proof-of-concept in patients with early-stage Parkinson's disease who had not previously been treated with carbidopa/levodopa. BioVie said the study's primary pharmacodynamic assessment focused on changes in a predefined panel of blood-based inflammatory markers, under a statistical analysis plan submitted to the U.S. Food and Drug Administration. The study also evaluated motor and non-motor endpoints, clinician-rated outcomes, quality of life, and safety and tolerability. ## Clinical results The release says that most patients treated with bezisterim improved on EPNIC-15, a composite endpoint of 15 clinically relevant motor and non-motor measures. Patients receiving placebo showed a change in the opposite direction. The release gives EPNIC-15 values of -0.04 for bezisterim and +0.18 for placebo, with a Cohen's d of -0.94 and a p value of 0.0006. The release says EPNIC-15 combines measures from UPDRS Parts I, II and III and the PDSS-2 sleep scale, which it describes as a sensitive tool for evaluating anti-inflammatory treatment effects in early Parkinson's disease. The composite neuroinflammation measure changed by -0.28 in patients treated with bezisterim, compared with +0.19 for placebo (Cohen's d = -1.06, p=0.0018). The release says this further supports an effect of bezisterim on neuroinflammatory pathways. Bezisterim treatment was also associated with statistically significant improvements in central and peripheral biomarkers of neuroinflammation, including CCL2, CHI3L1 and VGF, and in systemic inflammation markers, including the monocyte-to-lymphocyte ratio and the Systemic Inflammation Response Index. The release reports a proteome-wide impact, with 283 of 380 proteins shifting in the direction of a lower inflammatory burden. It also reports favorable changes in Aβ42 (p=0.0877) and pTau-217 (p=0.1272), and says the biomarker results provide evidence of biological target engagement. The release does not describe the Aβ42 and pTau-217 changes as statistically significant. Chief executive Cuong Do called the results exploratory in the release. ## Subgroup findings Patients with baseline platelet counts above 230 x10 3/µL, who represent approximately one-half of the trial population, showed statistically significant advantages over placebo across all clinical measures evaluated. Those measures include EPNIC-15, MDS-UPDRS Parts I, II and III, and MDS-UPDRS Total. The company said platelet levels may help enrich future trials for patients more likely to respond. The release quotes two outside neurology figures, Mark Stacy of the Medical University of South Carolina and James Beck of the Parkinson's Foundation, in support of the findings. ## About bezisterim According to the annual report for fiscal 2025, bezisterim, also called NE3107, is an oral small molecule that BioVie believes inhibits inflammation-driven insulin resistance. It is being studied in Alzheimer's disease, Parkinson's disease and Long COVID. ## What the release does not show The headline says the trial met its prespecified endpoints, but the release gives no patient count and no safety or adverse event data in the text reviewed. The clinical result is a composite of 15 items from existing scales. The change was -0.04 for bezisterim against +0.18 for placebo. The Aβ42 and pTau-217 changes did not reach significance (p=0.0877 and p=0.1272), and the chief executive himself calls the results exploratory. The platelet finding is a subgroup of about half the trial population. The release does not say the platelet split was set in advance, and it also says effects were seen across the platelet spectrum, so the subgroup is a hypothesis for a Phase 3 design, not a result that settles anything. A Phase 3 trial is still ahead, and the release gives no timing, funding or FDA agreement for it. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story BIVI BioVie Inc. NASDAQ · United States Open the starter desk ## More in Company Updates Company Updates ### [PTC reports third-quarter 2026 revenue of $358 million and raises product guidance](https://aibio.space/news/ptc-reports-third-quarter-2026-revenue-358-million-raises-product/) Oct 29, 2026 Company Updates ### [Processa clears VT-7208 CSU IND and names a new executive chair](https://aibio.space/news/processa-clears-vt-7208-csu-ind-names-new-executive-chair/) Oct 29, 2026 Company Updates ### [Kiora in-licenses late-stage KIO-401 for retinal artery occlusion](https://aibio.space/news/kiora-licenses-late-stage-kio-401-retinal-artery-occlusion/) Oct 29, 2026 --- Source page: https://aibio.space/news/biovie-reports-topline-results-phase-2-sunrise-pd-trial-parkinsons/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "BioVie reports topline results from Phase 2 SUNRISE-PD trial in Parkinson's", 2026-08-06, https://aibio.space/news/biovie-reports-topline-results-phase-2-sunrise-pd-trial-parkinsons/