Company: BIVIW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001520138-25-000343
Chunk: 83

Company: BIOVIE INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 2
Chunk 83
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 to the failure of either the
Company or a third party, a clinical trial fails to comply with applicable cGCPs, FDA’s IND requirements, other applicable regulatory
requirements, or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical
trials to support our marketing applications, which would delay the regulatory approval process. For example, our drug product candidate
bezisterim (NE3107) was cleared by FDA for use in a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter
study in subjects who have mild to moderate AD. Enrollment in that trial began in August 2021, with a planned primary completion in late
2022/early 2023. On November 29, 2023, the Company announced topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim
(NE3107) in the treatment of mild to moderate AD. Upon trial completion, as the Company began the process of analyzing the trial data,
the Company found significant deviations from the protocol and cGCP 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. We subsequently
notified FDA’s OSI of such significant deviations from study protocol, the suspected improprieties, and the study sites involved.
The identification of significant deviations from study protocol and numerous GCP violations at multiple study sites raised questions
regarding the validity and robustness of data from these study sites. The unplanned exclusion of so many patients left the trial underpowered
for its primary endpoints. However, based on the remaining dataset from those other sites determined to be in compliance with the protocol
and GCP’s, a preliminary signal of efficacy was detected. The Company is considering: (1) employing the adaptive trial feature of
the protocol to continue enrolling patients to achieve statistical significance; and/or (2) designing a new Phase 3 study of bezisterim
(NE3107) that leverages the most recent scientific literature relating to AD along with the company's understanding regarding the effects
of bezisterim (NE3107) in persons with mild-moderate AD.

Although we design the
clinical trials for our product candidates, our CROs are tasked with facilitating and monitoring these trials. As a result, many aspects
of our clinical development programs,