BioVie(US:BIVI) Newsfilterยท2024-06-25 12:00Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim (NE3107) for the treatment of Parkinson's disease, with a focus on both motor and non-motor symptoms, as highlighted in recent presentations at the ATMRD Congress [1][2][3]. Study Design and Objectives - The upcoming SUNRISE-PD trial is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate bezisterim in approximately 60 patients with early Parkinson's disease who have had minimal prior exposure to carbidopa/levodopa [4][5]. - The trial will last 20 weeks, including a 12-week double-blind phase where patients will be randomized to receive either bezisterim 20 mg or placebo twice daily [4][10]. Key Endpoints - The primary objective is to evaluate the efficacy of bezisterim in treating motor symptoms, specifically measuring changes in the MDS-UPDRS Part III score at week 12 [6][8]. - Secondary objectives include assessing the impact on non-motor symptoms, overall symptoms, and safety and tolerability of bezisterim [6][7][10]. Previous Trial Data - Data from a Phase 2a trial indicated that bezisterim, when used adjunctively with carbidopa/levodopa, showed improvements in both motor and non-motor symptoms of Parkinson's disease [11][12]. - Patients treated with bezisterim experienced a statistically significant improvement in MDS-UPDRS Part III scores compared to placebo, particularly in patients younger than 70 years [12][13]. Mechanism of Action - Bezisterim is characterized as an orally bioavailable, BBB-permeable insulin-sensitizer with anti-inflammatory properties, potentially addressing inflammation and insulin resistance associated with Parkinson's disease [15][17]. Broader Implications - The ongoing research into bezisterim also includes investigations for Alzheimer's disease, with previous studies showing promising results in cognitive function and biomarker levels [16][17].