BioVie expects clinical readouts for its lead drug candidate bezisterim this summer, with Parkinson’s disease data anticipated in late July or early August and Long COVID results expected around late August to early September, according to comments from President and CEO Cuong Do during a RedChip Companies webinar.
Parkinson’s and Long COVID Trials
Do said the company is targeting “late July, early August” for Parkinson’s trial results. In an earlier 40-patient trial combining bezisterim with levodopa in moderate to severe Parkinson’s disease patients, the combination showed greater muscle control than levodopa alone, and about one-third of patients receiving the combination were in an “on” state first thing in the morning before taking their morning medication. Some patients also reported improvements in sleep, anxiety and depression measures. To reduce placebo effects, BioVie used home-based nurse assessments, video recording, centralized rating, and included a placebo run-in period to exclude patients whose assessments changed significantly before randomization.
The Long COVID trial is fully enrolled with 200 patients split between placebo and bezisterim. The trial evaluates endpoints related to cognition, malaise, fatigue and biomarkers and is described as exploratory with about 20 endpoints. The study is supported by a $13 million grant and includes participation from Long COVID centers including Yale, Mount Sinai, Mayo Clinic, UCSF and Stanford. Do said the final patient visit is expected in early to mid-August, and if results are promising, BioVie would seek FDA discussions in the fall about accelerated approval or Emergency Use Authorization.
Alzheimer’s Program and Second Asset
Do said bezisterim targets TNF-alpha production rather than amyloid plaques. In a previous Phase 3 Alzheimer’s trial, bezisterim showed a 68% slowing of cognitive decline versus placebo after six months on the CDR-SB endpoint, compared with roughly 30% slowing for anti-amyloid drugs as a class after 18 months. Do noted the Alzheimer’s program is currently on hold due to funding needs, estimating each trial could cost $25 million to $30 million, with two trials needed for a total estimated cost of $50 million to $60 million.
BioVie’s second asset, BIV201, is being developed for ascites. Do said the company has filed an S-1 for Option Therapeutics and intends to place the ascites drug into that company, aiming to raise about $25 million to $30 million to fund a registrational trial estimated to take about two and a half years.
Do said BioVie has “sufficient cash to last towards the tail end of the year” and described the company’s market capitalization as about $10 million, which he said was below its current cash balance.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.thelincolnianonline.com/2026/06/05/biovie-eyes-summer-catalyst-as-parkinsons-long-covid-trial-readouts-near.html