BioVie Inc. announced that the Company has enrolled the first patient into the NM101 Phase III clinical study testing NE3107 for the treatment of Alzheimer’s Disease (AD). The NM101 study (NCT04669028) is a potentially pivotal Phase 3, randomized, double blind, placebo-controlled, US multicenter study of NE3107 in 316 subjects with mild to moderate AD. In addition to conventional cognition, memory, functional, behavioral and imaging end points, NM101 will assess measures of glycemic control, brain glucose utilization and systems dysregulation. The mechanistic basis for the study design was recently published in a peer-reviewed article in Neurodegenerative Disease Management. This study design and pathophysiology and mechanism data were also presented as Poster 55458 entitled “Rationale for an Anti-inflammatory Insulin Sensitizer in a Phase 3 Alzheimer’s Disease Trial” by Christopher L Reading, PhD, BioVie’s Executive Vice President for Neuroscience Research & Development at the 2021 Alzheimer’s Association International Conference (AAIC), July 28, 2021. The study aims to have data readout by the end of 2022. Inflammation also triggers inhibitory phosphorylation of Insulin Receptor Substrate 1/2, leading to insulin resistance (IR) and the inhibition of insulin signaling. As insulin is the master regulator of energy and metabolism, neuroinflammation’s disruption of insulin signaling is believed to contribute to AD pathology. The Mayo Clinic estimates that up to 81% of AD subjects have impaired glucose tolerance or type 2 diabetes mellitus. NE3107 is an oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK- and NF?B-stimulated inflammation. No major safety signals have been observed in preclinical and clinical studies to date.