Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 198

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 198
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 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 week 30 (end of study). Additional DNA methylation data continues to
be collected and analyzed.

Liver Disease Program

In liver disease, our investigational drug candidate BIV201 (continuous
infusion terlipressin), which was granted both FDA Fast Track designation status and FDA Orphan Drug Status, is being evaluated as a treatment
option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by non-alcoholic
steatohepatitis (NASH), hepatitis, and alcoholism. The initial target for BIV201 therapy was refractory ascites.

After receiving guidance from the FDA regarding the
design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting a
broader ascites patient population. The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus
on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis
and ascites who have recently recovered from acute kidney injury (“AKI”). This patient population is not limited to those
having refractory ascites. BIV201 is administered as a patent-pending liquid formulation with patents issued in US, China, Japan, Chile
and India to date.

In June 2021, the Company initiated a Phase 2 study
(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary
endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
to a pre-treatment period. By October 202