Blinded Data Presented at CTAD Suggest that NE3107 is Biologically Active and May Have Impact on Cognitive, Biomarker, and Imaging Endpoints Among Mild to Moderate Alzheimer’s Disease Patients

• Statistically significant population changes from baseline were observed for all primary and secondary cognitive and functional assessments measured: ADAS-Cog12, ADCS-CGIC, MMSE, CDR, CDR-SB, ADCOMS, and ADL.1  
• An apparent significant reduction in amyloid burden from baseline was observed in the population.
  • A significant change from baseline was observed in the Amyloid β 42/40 ratio and Amyloid Probability Score as shown by the PrecivityAD® tests from C2N Diagnostics.
  • Increased FDG-PET SUVRs were observed in 10 out of 21 patients in a brain imaging sub-study, which is suggestive of reduced amyloid burden.
• Statistically significant increases in insulin and beta cell function were observed without any hypoglycemia, which suggests target engagement and lends support for a previously identified potential mechanism of action for NE3107.
• The Company expects to announce unblinded, topline data from this trial in late November or early December.

CARSON CITY, Nev., Oct. 25, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, announced that blinded data on cognitive, biomarker and imaging findings from the recently completed Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate Alzheimer’s Disease (AD) were presented today as an oral presentation at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) in Boston, MA,

The presentation, Clinical Outcomes from a Phase 3, Randomized, Placebo-Controlled Trial of NE3107 in Subjects with Mild to Moderate Probable Alzheimer’s Disease, detailed a cross sectional analysis of blinded data from BioVie’s Phase 3 study and discussed participants whose data were available for analysis as of October 18, 2023 (n=322). These preliminary analyses will be updated once the complete and final dataset becomes available and when the study database is locked, unblinded and analyzed in full.

The blinded data presented suggest that NE3107 is a biologically active compound exerting potential effects as observed by biomarker, imaging, cognitive and functional assessments. Population changes from baseline were observed, with some patients demonstrating an improvement after 30 weeks of treatment with the double blinded oral study drug (NE3107 or matched placebo) as compared to baseline, while many were also observed to have worsened, which is consistent with the natural progression of the disease (Figure 1).

Since study participants diagnosed with dementia would typically be expected to worsen or experience no change as a function of time-related disease progression without active treatment, the observed “scattering” pattern in the blinded data suggests that NE3107 may have an impact on cognition and function among study participants, and the magnitude of cognitive and functional improvements observed is not consistent with typical placebo response observed in historical clinical studies in AD. While patients were randomized 1:1 to NE3107 vs. placebo, a plurality of subjects showed evidence of improvement and may have demonstrated effects unrelated to the administration of the study drug (NE3101 or placebo).

Figure 1. Cognitive and functional changes from baseline

Consistent directionality and significant correlations (p