Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 155

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 155
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 and PD.

Alzheimer’s Disease (NCT05083260)

On November 29, 2023, the Company announced the analysis
of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog
12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive
sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally
twice daily.

Upon trial completion, as the Company began the
process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices
(“cGCPs”) violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level
of suspected improprieties led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of
Scientific Investigations (“OSI”) for potential further action. After the patient exclusions, 81 patients remained in
the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial
and were verified to take study drug from pharmacokinetic data.

The trial was originally designed to be 80% powered
with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients has left the trial underpowered
for the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further
verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest
a slowing of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic
change. Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this
case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test
was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at