BioVie (NASDAQ:BIVI) executives and scientific presenters used a virtual key opinion leader (KOL) event to outline the scientific rationale behind the company’s Parkinson’s disease program and provide timing updates on two ongoing clinical trials.
Clinical trial timelines: Parkinson’s closeout and long COVID nearing completion
Cuong Do, BioVie’s president and chief executive officer, said the company’s Parkinson’s study is “nearly complete,” with the last patient having returned for a final visit. Do said the team is now in the study closeout process, including data cleanup, and is waiting on biomarker results to return from labs.
Do also said BioVie is enrolling a long COVID trial and expects the last patient visit to occur next week. If the process stays on track, Do said the company should be positioned to report top-line data “before the end of the summer.”
KOL presentation: Parkinson’s framed as metabolic and inflammatory, not only motor
Joe Palumbo, BioVie’s executive vice president of research and development and chief medical officer, said the event was intended to provide scientific context ahead of the company’s Parkinson’s data readout, emphasizing that Parkinson’s is more than a dopamine-driven motor disorder.
Suzanne de la Monte, a professor at Brown University and chief of pathology and laboratory medicine at the Providence VA Medical Center, presented on insulin resistance and metabolic dysregulation as key features of brain aging and neurodegeneration. She said Alzheimer’s disease has been called “type 3 diabetes” due to insulin deficiency and insulin resistance, and added that Parkinson’s “is not far behind” in terms of similar abnormalities.
De la Monte described neurodegeneration as a broader, multi-cell-type problem affecting neurons as well as oligodendrocytes, astrocytes, microglia, and vascular function. She argued that focusing solely on hallmark protein accumulations such as plaques, tangles, or Lewy bodies can miss a larger underlying driver: impaired brain metabolism and glucose utilization, which she characterized as “effectively a brain starvation.”
She also pointed to the influence of systemic co-factors—obesity, diabetes, hypertension, stroke, and environmental factors—saying they “muddy up” disease features and increase rates. In the Q&A, she said increasing rates of Alzheimer’s and Parkinson’s over recent decades “parallel the changes in obesity, diabetes, et cetera,” and argued that systemic insulin resistance can worsen ongoing brain dysfunction. She said addressing systemic metabolic problems would not eliminate Parkinson’s, but could “reduce the onset, severity” and likely delay progression, while brain-specific therapies are still needed once neurodegenerative cascades begin.
BioVie’s bezisterim: mechanism, selectivity, and biomarker strategy
Clarence Ahlem, BioVie’s senior vice president of operations, introduced bezisterim as a “novel anti-inflammatory agent” and a sterol that “does not target the steroid-binding nuclear hormone receptors.” He said bezisterim is orally bioavailable, crosses the blood-brain barrier, and targets extracellular signal-regulating kinase (ERK) in “pathology-specific signaling pathways,” without inhibiting ERK pathways involved in homeostasis.
Ahlem described bezisterim’s proposed mechanism as binding to ERK within a protein complex that includes MAP3K8 and NF-?B-related signaling components, aiming to reduce inflammatory cytokine production linked to chronic inflammation. He emphasized that ERK is also part of a different scaffold that supports insulin signaling, and said bezisterim does not interfere with ERK in that insulin-related scaffold. Ahlem said the drug was originally developed to improve insulin signaling in type 2 diabetes and argued that its selectivity for inflammatory signaling underpins what he called an “attractive safety profile.”
Ahlem also highlighted DNA methylation and epigenetic “age acceleration” as a potential biomarker strategy. He said BioVie previously observed improvements in DNA methylation-based biological age acceleration in Alzheimer’s patients treated with bezisterim, and said the company hopes to see similar results in the SUNRISE-PD Parkinson’s study, while noting the data “will have to speak for itself.” He added that BioVie has not met with the FDA to discuss DNA methylation as a biomarker, but said the approach “appears to have great potential.”
Palumbo: non-motor symptoms drive quality of life and remain underserved
Palumbo detailed how Parkinson’s symptoms can emerge years before classic motor diagnosis, citing non-motor features such as constipation, loss of smell, REM sleep disorder, depression, anxiety, fatigue, and cognitive slowing. He argued that by the time motor symptoms prompt diagnosis, “there’s already tremendous inflammation going on,” and non-motor symptoms have often already appeared.
Palumbo referenced a Michael J. Fox Foundation-funded study identifying key contributors to reduced quality of life—depression and anxiety, fatigue, sleep disruption, cognitive impairment, and autonomic dysfunction—saying these factors account for roughly 65% of quality-of-life impairment. He said there is no approved therapy specifically targeting those non-motor domains in Parkinson’s and that current approaches often rely on off-label symptom management rather than addressing underlying neuroinflammation.
He described BioVie’s testable hypothesis as targeting neuroinflammation early to improve non-motor symptoms and quality of life in the near term, while potentially influencing systems associated with motor progression over time.
What BioVie said it will look for in readouts
In audience Q&A, Palumbo said BioVie’s benchmarks for success in the Parkinson’s trial include demonstrating target engagement, mapping biological effects to clinical effects, and using the dataset to design the next study with greater precision. He said the company plans to analyze a large volume of genomic and biomarker information to define the “personality” of the molecule in early Parkinson’s.
On biomarkers, Palumbo said the company is looking at metabolic and inflammatory outcomes as well as epigenetic measures. Ahlem added that DNA methylation is central because evidence links biological age acceleration to disease progression, which he called the key unmet need in Parkinson’s. De la Monte suggested anchoring new biomarker findings to established Parkinson’s markers (including synuclein-related measures) and using panels of oxidative stress and inflammatory markers to track changes over time alongside clinical assessments of cognition, behavior, and sleep.
Closing the event, Do summarized his takeaways: metabolic dysregulation and insulin resistance as a root driver of disease, the close relationship between inflammation and insulin resistance, under-recognition of Parkinson’s non-motor symptoms, and the potential for bezisterim to address both motor and non-motor components. Do reiterated that BioVie expects to announce top-line results from its Parkinson’s trial by the end of the second quarter, with the possibility of slipping into the third quarter depending on biomarker timing and analysis.
About BioVie (NASDAQ:BIVI)
BioVie Inc is a clinical?stage biopharmaceutical company focused on developing novel therapies for chronic liver diseases and associated neurological complications. The company’s research and development efforts center on candidates designed to address serious unmet medical needs in hepatic encephalopathy and other liver?related disorders. BioVie advances its pipeline through controlled clinical trials and regulatory interactions in North America.
The company’s lead product candidate, BIV201, is undergoing Phase 2 clinical evaluation for the treatment of hepatic encephalopathy, a life?threatening condition marked by elevated neurotoxins in patients with advanced liver disease.
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