BioVie Inc., a clinical-stage company based in Carson City, Nevada, announced it has fully funded a Phase 2 clinical trial of bezisterim (NE3107) to assess the molecule in the treatment of early Parkinson’s disease (PD).
The compound, an oral small molecule, crosses the blood-brain barrier and has demonstrated anti-inflammatory and insulin-sensitizing properties in neurodegeneration models. Bezisterim inhibits extracellular signal-regulated kinase (ERK) signaling via multiple nuclear factor kappa B subunit 1 (NFkB) stimulated pro-inflammatory signaling, potentially exerting neuro-protective benefits to patients. It has been studied in patients with Type 2 diabetes, ulcerative colitis, rheumatoid arthritis, and Alzheimer’s disease. BioVie Inc. believes bezisterim’s proposed mechanism of action is “ … believed to be responsible for significant clinical improvements in several disease indications.”
A Phase 1/2 trial evaluating the drug’s safety, tolerability, and pharmacokinetics in patients with Parkinson’s who are also receiving immediate release levodopa / carbidopa completed in April 2023. Data were presented at the 2023 International Congress of Parkinson’s Disease and Movement Disorders and showed that bezisterim was well tolerated and did not affect the pharmacokinetic profile of immediate release levodopa / carbidopa. Further, patients showed significant improvements in both non motor and motor PD symptoms. Specifically, patients reported improvements in sleep, fatigue and restlessness and improvements in motor control.
Bezisterim was studied in a Phase 3 study in elderly patients with Alzheimer’s disease, but because of protocol violations, data from only a subset of patients could be used for analysis. The data showed improved cognition vs placebo, but did not reach statistical significance.
The Phase 2 SUNRISE PD trial is a 20-week, multicenter, randomized, double-blind, placebo-controlled trial. About 60 patients who’ve had minimal exposure to levodopa/carbidopa will be randomized 1:1 to receive either bezisterim 20 mg or placebo twice daily. The primary endpoint is change in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score at week 12, which measures key motor symptoms of PD.
Early next year, BioVie will launch an exploratory Phase 2 trial of bezisterim in Long Covid, followed by a Phase 3 trial of a once-daily formulation of bezisterim for Alzheimer’s in late 2025.
Reference:
Reading CL, Ahlem CN, Murphy MF. NM101 Phase III study of NE3107 in Alzheimer’s disease: rationale, design and therapeutic modulation of neuroinflammation and insulin resistance. Neurodegener Dis Manag. 2021;11(4):289-298. doi:10.2217/nmt-2021-0022
BioVie Inc. BioVie presents data for NE3107 at 2023 International Congress of Parkinson’s Disease and Movement Disorders. News release. Published August 28, 2023. Accessed January 31, 2025. https://feeds.issuerdirect.com/news-release.html?newsid=6980462181816032
BioVie Inc. BioVie’s upcoming Parkinson’s disease clinical trial is fully funded. News release. Published November 4, 2024. Accessed January 31, 2025. https://feeds.issuerdirect.com/news-release.html?newsid=5511688700914480
BioVie Inc. BioVie to present protocol design for upcoming Phase 2 trial of bezisterim in patients with early Parkinson’s disease at 2024 ATMRD Congress. Published June 20, 2024. Accessed January 31, 2025. https://feeds.issuerdirect.com/news-release.html?newsid=7199331634787799