Full Dataset from Phase 2a trial in Parkinson’s Disease suggest patients treated with bezisterim experienced significant improvements in both non-motor symptoms and motor control while placebo-treated patients worsened
Improvements in non-motor symptoms correlated with improvements
in motor symptoms for Parkinson’s Disease patients
The presentation Improvement of Motor and Non-Motor Symptoms with Bezisterim Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2A, Placebo-Controlled Study was presented on
Patients treated with bezisterim and levodopa/carbidopa experienced a -2.8 point advantage on the Patr III (Motor) score on the Motor Disease Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) compared to patients treated with placebo and levodopa/carbidopa. In patients younger than 70 years old (~50% of patients), the advantage for bezisterim-treated patients was -4.7 points. Furthermore, 30% of bezisterim-treated patients experienced improvement in their ability to move, having Part 3 scores prior to their first morning dose of carbidopa/levodopa that were equal to or better than Part 3 scores associated with their being in the “on” state after carbidopa/levodopa treatment at the start of the study, whereas none of the placebo patients had the similarly improved morning Part 3 scores. The difference was statistically significant (p=0.02).
Bezisterim-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson’s Disease, whereas placebo patients experienced a worsening of +1.0 points (p=0.0159). Sleep/fatigue domain improvements correlated with motor score improvements (r=0.51; p=0.0259). More patients on bezisterim had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened.
Bezisterim-treated patients experienced an improvement of -0.89 on the urge to move legs/restlessness in legs whereas placebo patients experienced a worsening of +0.99 (p=0.0321).
“These full dataset findings suggest that bezisterim as adjunct therapy to levodopa may hold promise in ameliorating specific non-motor symptoms of Parkinson’s Disease, particularly in sleep/fatigue and restlessness of the legs,” stated
About Bezisterim
Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-to-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFkB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation.
Bezisterim is being investigated for Alzheimer’s disease (AD) and Parkinson’s disease (PD). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in
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Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. In this press release, forward-looking statements include, but are not limited to, the potential impact of bezisterim on cognition and function among study participants and topline data from the bezisterim trial. Although
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