Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 162

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 162
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 for the treatment
of neurological symptoms that are associated with long COVID. The Company anticipates the trial to commence by early 2025.

Liver Disease Program

In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the
treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.

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.

In March 2023, the Company announced enrollment was
paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid
during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly
different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in
ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment
period.

In June 2023, the Company requested and subsequently
received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites
due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment
of ascites due to chronic liver cirrhosis.

The BIV201 development program was initiated by LAT
Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company currently
owns all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11,
2016, between our