BioVie announced two upcoming presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 to be held March 5-9, 2024 in Lisbon, Portugal. The presentation Improvement of Non-Motor Symptoms with NE3107 Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2A, Placebo-Controlled Study will be presented. NE3107-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale in Parkinson’s Disease, whereas placebo patients experienced a worsening of +1.0 points. Sleep/fatigue domain improvements correlated with motor score improvements. More patients on NE3107 had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened. NMSS changes for NE3107-treated patients were driven by improvements of -0.87 in fatigue/lack of energy and improvement of -2.91 on the urge to move legs/restlessness in legs. Placebo patients saw no significant change of -0.39 on fatigue and -0.71 on leg restlessness. The presentation Clinical Outcomes from a Phase 3, Randomized, Placebo-Controlled Trial of NE3107 in Subjects with Mild to Moderate Probable Alzheimer’s Disease. The NM101 Trial enrolled 439 patients through 39 sites. Baseline and completion data were available for 50 subjects, and DNA methylation data were available for 33 subjects in this cohort. Due to the exclusion of data from so many sites the trial missed statistical significance but showed promising directional data on cognitive and functional measures. NE3107-treated patients saw an advantage compared to placebo of -0.95 on CDR-SB, -0.9 on ADAS-COG-12, -0.43 on ADAS-CGIC, -0.03 on ADCOMS, +1.02 on MMSE, and +3.08 on ADCS-ADL. Significant improvements for NE3107-treated patients vs. placebo were observed for biological age deceleration, fasting glucose levels, cholesterol, HOMA2 beta cell function, HOMA2 Insulin Sensitivity, and MCP1. Trending improvements in HOMA2 Insulin Resistance of -0.020 were also observed.
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