BioVie presents data from Phase 3 study of NE3107 in AD patients

The company states: “BioVie announced that baseline data from its multicenter, randomized, placebo-controlled Phase 3 study of NE3107 in patients with mild to moderate Alzheimer’s Disease was presented as a poster at the 83rd Scientific Sessions of the American Diabetes Association, to be held June 23-26, 2023 in San Diego, CA. NE3107 is an oral small molecule, blood-brain permeable anti-inflammatory insulin sensitizer that binds extracellular signal-regulated kinase. BioVie’s Phase 3 trial is the largest study to date to evaluate the safety and efficacy of NE3107 in patients with AD. NE3107 is the only anti-inflammatory agent currently in phase 3 development for AD. Consistent with the proposed anti-inflammatory and insulin-sensitizing properties of NE3107, this phase 3 study was designed to confirm the efficacy and safety of NE3107 treatment in patients with probable AD. The poster, Metabolic Dysregulation in Probable Alzheimer’s Disease, discussed the role of insulin resistance and neuroinflammation in the risk of mild cognitive impairment, and details baseline metabolic and inflammation characteristics from the Phase 3 study, including data on the regulation of glycemia. Presenters noted that at baseline, the majority of patients had a high WHR (85%), hypertension (61%), and impaired glucose metabolism (IFG/T2D; 52%); almost half of all patients (47%) had some degree of insulin resistance; 40% and 30% of patients had hypertriglyceridemia and hypercholesterolemia, respectively; and patients had elevated inflammatory markers. Both Abeta+ and Abeta- patients with AD were enrolled in the study and had comparable CDR-SB scores indicative of mild dementia, but while Abeta+ patients had worse ADAS-Cog12 and MMSE scores, indicating lower cognitive functioning, Abeta- patients had significantly higher inflammation, insulin resistance, IFG, and hypertension, compared to their Abeta+ counterparts. Additional subgroup analysis revealed higher degrees of impaired glucose metabolism and insulin resistance among the APOE 4- patients compared to their APOE 4+ counterparts and comparable baseline MMSE scores, indicating that both groups had mild to moderate cognitive impairment. Investigators concluded that in the absence of classical risk markers, such as Abeta+ and APOE 4+, central obesity and age-related systems dysregulation, involving inflammation, hyperglycemia, insulin resistance, dyslipidemia, and hypertension, may contribute to probable AD and disease progression.”