BioVie Invited to Present Data on Bezisterim in Long COVID at the NIH’s RECOVER-TLC Third Annual Workshop
The signal-finding trial reported benefits concentrated in patients with greater baseline symptom burden, with safety similar to placebo.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
BioVie (NASDAQ: BIVI) will present Phase 2 bezisterim results for Long COVID at the RECOVER-TLC workshop on November 5, 2026. Dr. Penelope Markham will discuss the ADDRESS-LC trial at the event in Bethesda, Maryland.
BioVie reported a consistent trend toward improvement versus placebo across most efficacy measures. Participants with greater baseline fatigue, post-exertional malaise or cognitive impairment experienced the greatest benefits, including statistically significant improvements on multiple measures corresponding to their most pronounced symptoms. Safety and tolerability were similar to placebo. The trial enrolled approximately 200 patients and evaluated 22 clinical outcome measures, with no single endpoint pre-specified as the primary determinant of success.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointADDRESS-LC is fully funded through a $13.13 million U.S. Department of War award. 1.2× market cap
- Moderate pointBezisterim showed a trend toward improvement versus placebo across most patient-reported and objective efficacy measures.
- Minor pointHigher-symptom-burden subgroups had statistically significant improvements in multiple measures corresponding to their most pronounced symptoms.
- Minor pointBezisterim’s safety and tolerability in ADDRESS-LC were similar to placebo.
Negative
- Minor pointADDRESS-LC was signal-finding, with 22 outcome measures and no single pre-specified primary determinant of success.
News Explained
BioVie says the ADDRESS-LC study is fully funded through a
Key Figures
- Participants with symptoms in at least one domain
- approximately 78%
- ADDRESS-LC trial participants
- Clinical outcome measures
- 22
- No single endpoint pre-specified as the primary determinant of study success
- Trial enrollment
- approximately 200 patients
- ADDRESS-LC trial
- Bezisterim dose
- 20 mg twice daily
- Oral capsule in ADDRESS-LC
- Department of War award
- $13.13 million
- Fully funds the Long COVID study
Previous Covid-19 Reports
-
Earlier ADDRESS-LC report detailed statistically significant benefits in higher-baseline-symptom subgroups.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
post-exertional malaise medical
proof-of-concept medical
blood-brain barrier medical
nfκb technical
tnfα technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
CARSON CITY, Nev., Oct. 26, 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 the Company has been invited to present at the 2026 RECOVER–Treating Long COVID (RECOVER-TLC) Hybrid Workshop, hosted by the National Institute of Allergy and Infectious Diseases (NIAID) and the Foundation for the National Institutes of Health (FNIH) from November 4–5, 2026, in Bethesda, Maryland.
Dr. Penelope Markham, BioVie’s Senior Vice President and Program Lead for Long COVID, will share results from the Company’s Phase 2 ADDRESS-LC trial evaluating bezisterim for the treatment of the neurological symptoms of Long COVID at the “Recent Insights from Long COVID Clinical Trials” Panel Discussion on Thursday, November 5, being held from 9:10 –10:10 a.m. ET. The 2026 RECOVER-TLC hybrid workshop will provide updates on RECOVER-TLC clinical trials and emerging discoveries in Long COVID research. The event will also provide opportunities for community members to help inform future research priorities for RECOVER-TLC clinical trials.
The RECOVER-TLC Initiative was launched to accelerate the development of treatments for Long COVID, recognizing that millions of people continue to experience persistent symptoms following COVID-19 infection and that no therapies have yet been approved. To date, RECOVER-TLC has advanced four therapeutic candidates into clinical testing and continues to evaluate additional promising interventions for this underserved patient population.
The ADDRESS-LC trial showed treatment with bezisterim showed a consistent trend toward improvement across most patient-reported and objective efficacy measures compared with placebo. Patients with more severe baseline fatigue, post-exertional malaise (PEM), or objective cognitive impairment – symptoms affecting approximately
“We observed a consistent and clinically coherent pattern of improvement across measures of fatigue, post-exertional malaise, clinician- and patient-reported outcomes, and objective measures of cognitive function among patients with greater baseline symptom burden,” said Dr. Penelope Markham. “These findings provide valuable insights into which patients may benefit most from bezisterim and provide an important foundation for the design of a confirmatory Phase 3 study.”
About Long COVID
An estimated 17-20 million U.S. adults reported to be living with Long COVID,1 with 3.8 million experiencing significant limitation to their daily lives.2 Almost 50 percent of those with Long COVID develop persistent or intermittent symptoms.3 The neurological and neuropsychiatric symptoms are among the most common and disabling manifestations of the condition and include fatigue, PEM, sleep disturbance, and persistent sense of difficulty with thinking and memory.4 Chronic innate inflammation accompanied by ongoing immune dysregulation is among the leading hypotheses proposed to explain the symptoms in Long COVID, with numerous investigators describing findings in Long COVID that appear to be supportive of the intended biological targets of bezisterim. Currently, there are no FDA-approved treatment options for Long-COVID.
About the ADDRESS-LC trial
The Phase 2 ADDRESS-LC study (NCT06847191), which is fully funded by a grant from the U.S. Department of War (DoW), is a randomized (1:1), placebo-controlled, signal-finding proof-of-concept, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with Long COVID who have cognitive impairment sequelae and fatigue. The study compared bezisterim, administered as a 20 mg oral capsule twice daily, with a matching placebo to assess its effects on neurocognitive and fatigue-related symptoms. The trial evaluated 22 clinical outcome measures, with no single endpoint pre-specified as the primary determinant of study success. Endpoints include assessing changes in overall clinical benefit, subjective and objective cognitive function, fatigue, sleep disturbance, Quality of Life and PEM. As a signal-finding study, the trial was designed to identify efficacy signals, measure treatment effect magnitude, and identify patient subgroups most likely to benefit, to inform the design of future Phase 3 trials.
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, TNFα), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease (PD), Long COVID (LC), and Alzheimer’s disease (AD).
In PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to establish proof of mechanism and proof of concept in individuals with early-stage disease who had not previously been treated with carbidopa/levodopa. Topline results showed that patients treated with bezisterim experienced improvements with blood-based markers of inflammation, as well as a broad range of biomarkers associated with cellular health and neuronal integrity. Clinically, patients treated with bezisterim showed numerically greater improvement than those receiving placebo across multiple measures of daily functioning, motor symptoms, and non-motor symptoms.
For LC, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with LC. The hypothesis 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).
In AD, BioVie has conducted 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 AD.
Terms of the U.S. Department of War (DoW) Award
The Long COVID study is supported by the Assistant Secretary of War for Health Affairs and endorsed by the DoW by a fully funded award in the amount of
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. Forward-looking statements in this release include, but are not limited to, statements regarding: the potential for bezisterim to address unmet clinical needs in Long COVID and Parkinson’s disease; the design and conduct of future clinical trials, including a potentially pivotal Phase 3 trial; the potential clinical significance of subgroup analyses and biomarker observations; and the Company’s ability to advance bezisterim through clinical development. The clinical endpoints reported in this release are exploratory in nature. The Phase 2 ADDRESS-LC trial did not achieve statistical significance on any endpoint in the overall intent-to-treat population; statistically significant results were observed only in pre-specified subgroup analyses. Subgroup analyses are hypothesis-generating and may not be replicated in future trials. Changes in biomarkers may not correlate with clinical benefit or support regulatory approval. The FDA has not validated these endpoints as surrogate endpoints for Long COVID. 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 risks related to the early stage of development of bezisterim and other product candidates, the possibility that results observed in this Phase 2 study of 203 patients may not be replicated in larger or longer-duration trials, the exploratory nature of subgroup analyses, 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 trials, 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
_________________________________
1 U.S. Department of Health and Human Services (https://www.hhs.gov/longcovid/index.html)
2 Bonuck et al. Commun Med. 2026;6:177. doi:10.1038/s43856-026-01516-7.
3 Thaweethai et al. Nat Commun. 2025;16(1):9557. doi:10.1038/s41467-025-65239-4.
4 Geng et al. JAMA. 2025 Feb 25;333(8):694-700. doi: 10.1001/jama.2024.24184.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did BioVie’s ADDRESS-LC trial show for bezisterim in Long COVID?
BioVie reported a consistent trend toward improvement versus placebo across most patient-reported and objective efficacy measures. Patients with greater baseline symptom burden experienced the greatest benefits, including statistically significant improvements in multiple measures corresponding to their most pronounced symptoms. Safety and tolerability were similar to placebo.
How was BioVie’s ADDRESS-LC trial designed and what dose was tested?
ADDRESS-LC was a randomized (1:1), placebo-controlled, multicenter proof-of-concept trial testing a 20 mg oral capsule of bezisterim twice daily against matching placebo. It enrolled adults with Long COVID who had cognitive impairment and fatigue, and was designed to identify efficacy signals and patient subgroups to inform future Phase 3 trials.
Who funded BioVie’s ADDRESS-LC Long COVID trial?
The trial is fully funded by a $13.13 million U.S. Department of War award through the Peer-Reviewed Medical Research Program. The award supports the Long COVID study; the company’s interpretations and conclusions are not necessarily endorsed by the department.