BioVie Unveils SUNRISE-PD Phase 2 Trial Design for Early Parkinson’s at ATMRD 2024

BioVie Inc., a clinical-stage company focused on developing innovative treatments for neurological and neurodegenerative disorders, recently presented significant data at the Advanced Therapeutics in Movement and Related Disorders Congress® (ATMRD Congress) in Washington, D.C. The presentations included details on the upcoming SUNRISE-PD Phase 2 trial and reinforced findings from an earlier Phase 2a trial in Parkinson’s disease (PD).

The SUNRISE-PD trial aims to evaluate the impact of bezisterim (NE3107) on both motor and non-motor symptoms in approximately 60 patients with early-stage Parkinson’s disease, who have had minimal exposure to carbidopa/levodopa (C/L). This Phase 2, multicenter, randomized, double-blind, placebo-controlled trial features a hybrid decentralized design and will last 20 weeks, including a 12-week double-blind phase. Patients will be randomized to receive either bezisterim or placebo twice daily.

The primary objective of the SUNRISE-PD trial is to assess the efficacy of bezisterim in treating motor symptoms of Parkinson’s disease, measured by changes in the MDS-UPDRS Part III score at week 12. Secondary objectives include evaluating bezisterim's impact on non-motor symptoms and overall symptoms as assessed by clinicians, as well as patient-reported outcomes. Exploratory endpoints will examine the effects of bezisterim on various aspects of Parkinson’s disease, such as DNA methylation and plasma biomarkers of inflammation.

Patients participating in the trial can choose to complete the study entirely from home or at a clinical site. Home-based participants will receive visits from study nurses, who will conduct assessments with the help of a neurologist attending remotely via video. Positive results from the trial could make patients eligible for a longer-term, open-label safety study in the future.

Additionally, BioVie presented data from a Phase 2a trial of bezisterim as an adjunctive treatment to C/L. This encore presentation highlighted improvements in both motor and non-motor symptoms in Parkinson’s disease patients. The Phase 2a trial showed that bezisterim-treated patients had better outcomes on the MDS-UPDRS Part III score compared to those on placebo, particularly in patients under 70 years old. Notably, 30% of bezisterim-treated patients exhibited improvements in their mobility scores before their first morning dose of C/L, a statistically significant difference from placebo.

Bezisterim also demonstrated significant improvements in the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson’s disease. Patients on bezisterim experienced improvements in sleep and fatigue, correlating with better motor scores. Furthermore, bezisterim-treated patients showed a reduction in restlessness in legs compared to those on placebo.

Bezisterim (NE3107) is an orally bioavailable, blood-brain barrier-permeable insulin sensitizer that also possesses anti-inflammatory properties. It is not immunosuppressive and carries a low risk for drug-to-drug interactions. Apart from its potential in Parkinson’s disease, bezisterim is being investigated for Alzheimer’s disease (AD). Data from a Phase 3 study in AD patients and a Phase 2 investigator-initiated trial have shown promising results in improving cognition and biomarker levels.

BioVie Inc. is committed to advancing drug candidates for neurological and neurodegenerative diseases and advanced liver disease. Their lead candidates include bezisterim, which inhibits inflammatory pathways implicated in neuroinflammation and insulin resistance, key drivers of Alzheimer's and Parkinson's diseases, and BIV201 for the treatment of ascites due to chronic liver cirrhosis. The company's innovative approach aims to address significant unmet medical needs and improve patient outcomes in these challenging medical conditions.