Company: BIVIW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001520138-25-000343
Chunk: 59

Company: BIOVIE INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 8
Chunk 59
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odopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off
state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design
objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for
adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications
of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.

To extend this Phase 2 data in progressed patients,
the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset
PD. In July 2024, the Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with
the study. The trial commenced in April 2025.

Long COVID Program

In April 2024, the Company was awarded a clinical
trial grant of $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research
Program of the Congressionally Directed Medical Research Programs. In August 2024, the FD&A and the U.S. Army Medical Research and
Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan, including the FDA approving
the associated Investigation New Drug Application (“IND”), to evaluate bezisterim for the treatment of neurological symptoms
that are associated with long COVID. The trial commenced in May 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 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.
These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have
an estimated 50% mortality rate within 6 to 12 months.

After receiving guidance