Announcement • May 19
BioVie Inc. Completes Phase 2 Sunrise-Pd Trial In Early-Stage Parkinson’s Disease
BioVie Inc. announced that the last patient evaluation visit has been completed for the Company’s SUNRISE-PD Phase 2 trial evaluating its drug candidate bezisterim in early-stage Parkinson’s disease. The company recently hosted a virtual key opinion leader (KOL) event featuring Suzanne de la Monte, MD, MPH, professor in Pathology and Laboratory Medicine, Neurology, & Neurosurgery at the Warren Alpert Medical School of Brown University, who joined company management to discuss the importance of insulin resistance in disease pathology and bezisterim’s mechanism of action in relation to the pathology and progression of neurodegenerative conditions, including Parkinson’s disease. The event also discussed the need to address Parkinson’s non-motor symptoms, including sleep disorder, anxiety, depression and cognitive slowness. SUNRISE-PD is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial in early-stage Parkinson’s disease patients who have not been treated with carbidopa/levodopa. The study leveraged a hybrid decentralized design that lasted 20 weeks from the initial screening phase to the safety follow up. During the 12-week double-blind phase, 57 patients were randomized 1:1 to receive either 20 mg of bezisterim or placebo twice daily. The study was designed to reduce common barriers to participation in PD research, including delayed diagnosis, limited mobility, geographic constraints, and access to specialized care, and allowed patients to participate either from their home or at a clinical site. At-home participants were visited by study nurses who administrated a modified MDS-UPDRS1 Part III and standard Part I and II examinations under the supervision of a physician and MDS-UPDRS expert attending through live video link. The Part III exam was recorded for review and scoring by a central rating committee. The study prospectively assessed a series of motor and non-motor endpoints using a predefined battery of biologic, clinical, and quality-of-life assessments to evaluate signals consistent with the expected metabolic and anti-inflammatory actions of bezisterim. Assessments include UPDRS Parts I, II, and III, the Parkinson’s Disease Questionnaire (PDQ), the Parkinson’s Disease Sleep Scale (PDSS), and Clinical Global Impression of improvement and severity (CGI-I and CGI-S). The study’s endpoint selection was informed by the underlying biology of Parkinson’s disease and the hypothesized mechanism of action of bezisterim. In parallel, the study evaluated plasma biomarkers of inflammation and neurodegeneration, including DNA methylation, to examine whether observed clinical findings are accompanied by biologic changes consistent with the proposed systems-level effects of bezisterim, and its potential to alter symptoms and progression in early-stage Parkinson’s disease. Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NF?B, TNF-a), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease. In Parkinson’s disease, BioVie has completed a Phase 2 study in which patients with moderate- to severe-stage Parkinson’s disease taking bezisterim with levodopa had better motor control and reported fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD study has completed enrollment of 60 patients to evaluate whether bezisterim alone may help improve motor and non-motor symptoms in Parkinson’s patients who have not been treated with carbidopa/levodopa. Topline results are expected in calendar Third Quarter 2026. For Long COVID, the ADDRESS-LC trial is enrolling approximately 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long COVID. The hypothesis being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NF?Bactivation (which bezisterim has been shown to modulate). Topline data is expected late summer 2026. In Alzheimer’s disease, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s.
