BioVie, Inc.: BioVie Announces Topline Results from Phase 2 ADDRESS-LC Trial Evaluating Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID

BioVie's lead drug, Bezisterim, showed improvements in fatigue, malaise, and brain fog in a long COVID clinical trial, according to CEO Cuong Do. The NIH has not seen similar results in other long COVID studies. BioVie plans to analyze biomarker data and seek FDA feedback for a Phase 3 trial. The company is also advancing Bezisterim for Parkinson's disease.

BioVie Inc. (BIVI, BIVIW) announced plans to advance its Phase 3 trial for bezisterim in Parkinson’s disease, with an End-of-Phase 2 meeting requested with the FDA. The trial will focus on motor symptoms (MDS-UPDRS Part III) as the primary endpoint, with non-motor symptoms (MDS-UPDRS Part I) as a co-primary or secondary endpoint. Phase 2 results suggested greater benefits for patients with higher inflammation levels. The company expects to discuss the trial design with the FDA later this year an

BioVie (NASDAQ: BIVI) shares fell after Phase IIb Parkinson’s trial data. On Aug. 6 the stock opened 33.3% lower at $1.36, briefly down nearly 60% to $0.82, then closed at $1.35, down 33.8% from Aug. 5. The data were released alongside a filing for a stock offering at $1.33 per share.

BioVie (BIVI) reported topline Phase 2 SUNRISE-PD results for Bezisterim in early-stage Parkinson’s. The drug met its primary endpoint with statistically significant improvements on motor and non-motor measures versus placebo, while adverse reactions were more frequent in the placebo arm (39.3% vs 51.7%). BioVie plans to advance to Phase 3.

BioVie Inc (NASDAQ:BIVI) reported positive Phase 2 SUNRISE-PD results for its Parkinson's candidate bezisterim. The drug met prespecified endpoints in early-stage, untreated patients, improving blood inflammatory markers and EPNIC-15 versus placebo. Benefits were strongest in patients with higher baseline platelet counts. Safety was similar to placebo, with 39.3% adverse events vs 51.7%.

BioVie Inc (NASDAQ:BIVI) said its Phase 2 long COVID trial of bezisterim is fully enrolled, with more than 200 patients randomized to placebo or bezisterim. CEO Cuong Do said the study includes sites such as Yale, Mount Sinai, Mayo Clinic and Stanford, targeting symptoms like brain fog, malaise and fatigue. Top-line results are expected by late October or as early as September; the company plans FDA discussions on accelerated approval or EUA if data support benefit-risk.