Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 55

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 55
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 (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 2022, there were 15 patients enrolled for treatment and the last patient completed treatment
in May 2023.

In March 2023, 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. 

The BIV201 development program was initiated by LAT
Pharma LLC. On April