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BioVie Presents Data Highlighting Baseline Characteristics of Study Population in Phase 3 Trial of NE3107 in Mild to Moderate Alzheimer’s Disease
Data from Phase 3 Trial of NE3107 Presented as Poster at the 148th American Neurological Association Annual Meeting CARSON CITY, Nev., Sept. 11, 2023 (GLOBE
About this update from Biovie Inc.
[{"type":"text","content":"Data from Phase 3 Trial of NE3107 Presented as Poster at the 148th American Neurological Association Annual Meeting CARSON CITY, Nev., Sept. 11, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that preliminary baseline data from its multicenter, randomized, placebo-controlled Phase 3 study (NCT04669028) of NE3107 in patients with mild to moderate Alzheimer’s Disease (AD) was presented as a poster at the American Neurological Association (ANA) annual meeting, being held September 11-13, 2023 in Philadelphia, PA. The poster, Metabolic Dysregulation in Probable Alzheimer’s Disease (Christopher Reading, et al), is being presented by Joseph Palumbo, Chief Medical Officer of BioVie, and highlights the preliminary baseline metabolic and inflammation characteristics from the Phase 3 study population (see Table 1). “The poster presentation does not reveal new data readouts,” stated Dr. Palumbo. “Instead, it provides an understanding of the patient population at the start of the trial, as understood to date. When looking at this preliminary baseline data in its totality, we see that patients enrolled in the trial have underlying medical conditions that are known risk factors for dementia.” BioVie is targeting primary completion of this study in the fourth quarter of calendar year 2023. Following the completion of all patients’ participation in the study, the clinical team will enter final data into the electronic data system, resolve any outstanding queries, and begin the cleaning process leading to database lock. At baseline, the majority of the study population are coded with abdominal obesity (85%), hypertension (61%), and impaired glucose metabolism (IFG/T2D; 52%). Almost half of all patients (47%) are coded as having some degree of insulin resistance, 40% and 30% of patients are coded as having hypertriglyceridemia and hypercholesterolemia, respectively; and patients are coded as having elevated inflammatory markers. Since these are known dementia risk factors, we believe NE3107’s potential ability to help patients improve on some of these factors, as shown in some prior clinical trials, suggests that it may help patients improve on...