BioVie, Inc. develops clinical-stage drug therapies for neurological and neurodegenerative diseases and advanced liver disease. Company news centers on bezisterim, also known as NE3107, an investigational oral small molecule studied in Parkinson’s disease, Alzheimer’s disease and Long COVID through its effects on neuroinflammation and insulin sensitivity.
Recurring updates include clinical-study enrollment and results planning, scientific-conference abstracts, key opinion leader events and investor presentations. BioVie also reports on BIV201, its orphan drug candidate for refractory ascites associated with liver cirrhosis, alongside corporate communications about pipeline progress and financing activity.
BioVie (NASDAQ: BIVI) has initiated patient enrollment in its Phase 2 ADDRESS-LC clinical trial evaluating bezisterim (NE3107) for treating neurological symptoms of long COVID. The trial, funded by the U.S. Department of Defense, is a randomized, placebo-controlled study focusing on patients with cognitive impairment and fatigue. Topline data is expected in the first half of 2026.
Long COVID affects approximately 20 million adults in the US, with 10-30% of COVID-19 patients experiencing persistent symptoms. The study aims to address the lack of approved treatment options for long COVID patients suffering from debilitating fatigue and brain fog. Bezisterim targets key neuroinflammation mechanisms and has shown potential in reducing chronic symptoms in Alzheimer's and Parkinson's disease trials.
BioVie (NASDAQ: BIVI) announced a virtual Key Opinion Leader (KOL) event scheduled for May 28, 2025, focusing on their Phase 2 trial of bezisterim (NE3107) for Parkinson's disease treatment. The event will feature experts Dr. Suzanne de la Monte from Brown University and Dr. Mark Stacy from Medical University of South Carolina.
The discussion will center on the SUNRISE-PD trial, which is currently enrolling newly diagnosed Parkinson's patients. Bezisterim is an oral small molecule designed to reverse insulin resistance and selectively inhibit inflammation-driven processes. The study aims to evaluate the drug's impact on clinical signs and biomarkers potentially related to disease modification.
BioVie Inc. (NASDAQ: BIVI) has initiated the Phase 2 SUNRISE-PD clinical trial to evaluate bezisterim (NE3107) in early Parkinson's disease patients who haven't received carbidopa/levodopa treatment. The trial has enrolled its first patient, with topline data expected in late 2024 or early 2025.
The study is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial featuring a hybrid decentralized design lasting 20 weeks. Approximately 60 patients will be randomized 1:1 to receive either 20 mg of bezisterim or placebo twice-daily over a 12-week double-blind phase.
Key features include:
- Remote participation option through decentralized trial sites
- Support from major organizations including The Michael J. Fox Foundation
- Full funding secured in November 2024
- Focus on bezisterim's anti-inflammatory and insulin-sensitizing properties
BioVie Inc. (NASDAQ: BIVI) announced a virtual investor event scheduled for April 10, 2025, at 10:00 AM ET, featuring Key Opinion Leader Dr. Lindsay McAlpine from Yale University. The webcast will focus on the long COVID treatment landscape and provide updates on BioVie's ADDRESS-LC trial.
The trial evaluates bezisterim (NE3107), a novel oral anti-inflammatory and insulin-sensitizing agent that can cross the blood-brain barrier. The drug selectively inhibits inflammation-driven ERK- and NF-κB-stimulated inflammatory mediators while preserving their homeostatic functions. The discussion will address how chronic neuroinflammation, potentially caused by persisting viral spike protein, may explain long COVID symptoms persistence.
BioVie (NASDAQ: BIVI) announced the acceptance of an abstract detailing their planned Phase 2 trial of bezisterim for Long COVID treatment at the Demystifying Long COVID International Conference in Barcelona. The study, fully funded by the U.S. Department of Defense, will be a double-blind, randomized, placebo-controlled trial involving approximately 200 patients. The trial aims to evaluate the safety, tolerability, and potential efficacy of bezisterim over a 3-month treatment period, focusing on reducing neurocognitive symptoms associated with Long COVID. The presentation will be delivered on November 21, 2024.
BioVie (NASDAQ: BIVI) has secured full funding for its upcoming PD-202 Parkinson's Disease clinical trial through recent secondary offerings raising over $15 million. The double-blind, randomized, placebo-controlled study of bezisterim in early Parkinson's Disease patients is scheduled to begin in early 2025, with topline results expected by late 2025. The company's lead asset, bezisterim, has shown promising results in clinical studies, demonstrating reduced inflammation, improved motor function, and decreased non-motor symptoms in PD patients. BioVie's strategic plans include launching Phase 2 trials for PD and Long Covid in early 2025, followed by a Phase 3 trial for Alzheimer's Disease in late 2025.
BioVie Inc (Nasdaq: BIVI) has completed its previously announced registered direct offering of 1,146,000 shares of common stock at $2.83 per share, raising gross proceeds of $3,243,180. The clinical-stage company, which develops drug therapies for liver disease and neurological disorders, plans to use the net proceeds for working capital and general corporate purposes. ThinkEquity served as the sole placement agent for the offering, which was conducted under a shelf registration statement filed with the SEC in August 2023.
BioVie Inc. (NASDAQ: BIVI) has announced the pricing of a registered direct offering of 1,146,000 shares of common stock at $2.83 per share, aiming to raise approximately $3.2 million in gross proceeds. The offering, priced at-the-market under Nasdaq rules, is expected to close around October 29, 2024. ThinkEquity is serving as the sole placement agent. The company plans to use the net proceeds for working capital and general corporate purposes. The securities are being offered through a shelf registration statement previously filed with the SEC.