BioVie Pursues Novel Approaches for Alzheimer's, Parkinson's, and Long COVID

NEW YORK, NY – November 19, 2025

BioVie Inc. (NASDAQ: BIVI) is forging ahead with a diversified clinical pipeline focused on addressing significant unmet needs in neurological disorders and liver disease. The company, hosting an investor webinar on December 9th, is garnering attention for its unique approach to tackling Alzheimer’s, Parkinson’s, and the lingering neurological symptoms of Long COVID, alongside a late-stage program for a serious liver complication. While navigating the inherent risks of clinical-stage biotech, BioVie is attempting to differentiate itself through a focus on neuroinflammation and a novel formulation for refractory ascites.

Addressing Neurodegenerative Diseases with Bezisterim

At the heart of BioVie’s neurological programs is bezisterim (formerly NE3107), an oral small molecule designed to cross the blood-brain barrier and selectively inhibit inflammation and insulin resistance. The company believes these mechanisms are central to the progression of Alzheimer’s and Parkinson’s disease. Recent Phase 3 data, though complicated by protocol deviations at several sites, suggested a positive trend in cognitive performance for Alzheimer’s patients. However, the statistically insignificant results from the reduced patient cohort have prompted an adaptive trial design to gather more robust evidence.

“The initial data, despite the challenges with the trial sites, showed a signal that’s worth pursuing,” notes one industry observer. “The fact that they’re willing to adapt the trial design based on the initial findings suggests a commitment to getting it right.”

The approach stands in contrast to some of the recent FDA-approved therapies for Alzheimer’s, which target amyloid plaques. BioVie argues that targeting neuroinflammation offers a complementary pathway and may provide benefit for a broader patient population. Data from a Phase 2a study in Parkinson's disease, where bezisterim was used alongside levodopa, showed improvements in both motor and non-motor symptoms. A new Phase 2 trial, SUNRISE-PD, is now underway to evaluate bezisterim in early-stage patients before they begin levodopa therapy, with the goal of potentially slowing disease progression.

Perhaps the most intriguing aspect of BioVie’s approach is its investigation of bezisterim for the neurological symptoms of Long COVID. “Long COVID is a rapidly growing and under-addressed health crisis,” comments a researcher familiar with the condition. “The potential to address ‘brain fog’ and fatigue with a targeted anti-inflammatory agent is a significant opportunity.” The company recently initiated a Phase 2 trial to evaluate bezisterim in this patient population, based on the theory that sustained inflammation plays a key role in the chronic neurological symptoms.

BIV201: A Novel Formulation for Refractory Ascites

Beyond neurological disorders, BioVie is also developing BIV201, a novel liquid formulation of terlipressin, for the treatment of refractory ascites, a life-threatening complication of advanced liver cirrhosis. Terlipressin is already approved in many countries for related complications, but BioVie believes its continuous infusion formulation could offer improved efficacy and convenience. The program has received Orphan Drug and Fast Track designations from the FDA, underscoring the unmet medical need in this patient population. The company hopes that its unique formulation will offer advantages over existing treatments and address a substantial market need.

Navigating the Biotech Landscape and Financial Considerations

BioVie operates in a highly competitive and capital-intensive industry. Bringing a drug to market requires significant investment in clinical trials, regulatory approvals, and commercialization efforts. The company’s financial stability and ability to secure funding will be crucial to its success. Recent SEC filings reveal a focus on managing cash flow and exploring strategic partnerships.

“Small biotech companies like BioVie face a constant challenge in balancing innovation with financial sustainability,” explains one financial analyst specializing in the biotech sector. “They need to demonstrate clear clinical progress and attract investment to keep their programs moving forward.”

The company’s reliance on investor funding and its potential need for future capital raises could present risks for shareholders. However, the diversified pipeline, with programs in multiple therapeutic areas, could mitigate some of those risks. The Orphan Drug and Fast Track designations for BIV201, along with the potential for a novel treatment for Long COVID, could also attract investor interest and strategic partners.

The upcoming investor webinar is expected to provide further clarity on BioVie’s clinical progress, financial outlook, and future plans. Investors will be closely watching for updates on the Phase 3 Alzheimer’s trial, the SUNRISE-PD trial, and the BIV201 program. The company’s ability to successfully navigate the challenges of clinical-stage biotech and deliver on its promises will ultimately determine its long-term success.