CARSON CITY, Nev., April 27, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced that it will host a virtual key opinion leader (KOL) event on Thursday, May 7, 2026 at 2:00 PM ET featuring Suzanne de la Monte, MD, MPH (Brown University Warren Alpert Medical School, Providence VA Medical Center), who will join company management to discuss how bezisterim’s mechanism of action could potentially address the pathology and progression of neurodegenerative diseases, including Parkinson’s disease. To register, click here.
The event will provide an update on BioVie's Phase 2 trial evaluating bezisterim (NE3107), an investigational drug candidate, for the treatment of Parkinson's disease. Bezisterim is a novel, orally-administered small molecule that, in preclinical and early clinical studies, has demonstrated potential to reduce insulin resistance and selectively inhibit inflammation-driven ERK- and NF-κB-stimulated inflammatory mediators without inhibiting their homeostatic functions. Inflammation and the associated insulin resistance contribute significantly to the development and progression of Parkinson's symptoms.
A live question and answer session will follow the formal presentations.
About Suzanne de la Monte, MD, MPH
Suzanne de la Monte, MD, MPH is Professor in Pathology and Laboratory Medicine, Neurology, & Neurosurgery at the Warren Alpert Medical School of Brown University and Chief of Pathology & Laboratory Medicine at the Providence VA Medical Center. Dr. de la Monte is also a medical staff member at the Rhode Island Hospital and Women and Infants Hospital of Rhode Island and formerly a research fellow at the National Institutes of Health. She received residency training in Anatomic and Pediatric Pathology at Johns Hopkins and fellowship training in Neuropathology at the Massachusetts General Hospital (MGH). Dr. de la Monte leads programs in basic, translational, and clinical research on mechanisms and consequences of brain insulin resistance and metabolic dysfunction and coined the term ‘Type 3 Diabetes’. She has over 300 peer-reviewed articles published.
About Bezisterim
Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNF-α), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease.
In Parkinson’s disease, BioVie has completed a Phase 2 study in which patients with moderate- to severe stage Parkinson’s disease taking bezisterim with levodopa had better motor control and reported fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD is evaluating whether bezisterim alone can help improve motor and non-motor symptoms in Parkinson’s patients who have not been treated with carbidopa/levodopa. Topline results are expected in mid-2026.
For Long COVID, the ADDRESS-LC trial is enrolling about 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long COVID. The hypotheses being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). Topline data is expected mid-2026.
In Alzheimer’s disease, BioVie has conducted both Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s.
About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead investigational drug candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for Long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue.
In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit www.bioviepharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate," "intend," "plan," "believe," "seek," "estimate," "will," "project," “potential,” “may,” or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to risk related to the early stage of development of bezisterim and other product candidates the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, the possibility that clinical trial results may not be indicative of results in subsequent or larger tirals, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
For Investor Relations Inquiries:
Contact:
Chuck Padala
Managing Director, LifeSci Advisors, LLC
chuck@lifesciadvisors.com
For Media Inquiries:
Contact:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com
