NE3107 Phase 3 Clinical Trial in Alzheimer's Disease
BioVie has received authorization from the FDA to initiate a phase 3 trial with NE3107 in patients with mild to moderate AD (Mini Mental State Exam scores of 14-24, Clinical Dementia Rating 1-2) with evidence of amyloid deposition in the brain and no evidence of an underlying pathology other than AD consistent with the observed cognitive impairment (such as vascular pathology; stroke for example). In addition to evaluating NE3107 safety in this patient population, the trial will measure how NE3107 impacts cognition with the Alzheimer’s Disease Assessment Scale Cognitive subscale 12 (ADAS-Cog 12 ) and function with the Alzheimer’s Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) after 30 weeks of treatment.
BIV201 Phase 2b Clinical Trial in Ascites
BioVie completed a Phase 2a open-label clinical trial of BIV201 (continuous infusion terlipressin) in 6 patients with ascites that is refractory to diuretics or intractable (the patient cannot tolerate diuretic drugs) in 2019. A subsequent randomized, controlled Phase 2b trial with target enrollment of 30 subjects is currently underway, with 20 refractory ascites patients expected to receive BIV201 therapy compared to 10 patients who will receive standard-of-care (regular paracentesis procedures). The company anticipates reporting top-line study results in early 2022. If positive, BioVie plans to commence a pivotal Phase 3 study later that year.