BioVie Announces Data Highlighting Bezisterim’s Potential to Slow or Reverse Biological Aging and Neurodegeneration Featured as a Keynote Talk at the 7th World Aging and Rejuvenation Conference
BioVie (NASDAQ: BIVI) presented promising data on bezisterim at the 7th World Aging and Rejuvenation Conference, highlighting its potential to slow biological aging and neurodegeneration. The Phase 3 NM101 study analysis revealed that bezisterim-treated Alzheimer's patients showed significant biological age reduction compared to placebo across multiple epigenetic clocks, with differences ranging from -1.38 to -4.24 years.
The study demonstrated bezisterim's ability to modulate inflammation and gene activation, with treated patients showing significant improvements in key biomarkers including -8.5 mg/dL in fasting glucose, -15 mg/dL in cholesterol, and -90.5 pg/mL in MCP. Bezisterim, a stabilized version of Beta AET, uniquely offers oral availability and blood-brain barrier penetration while maintaining favorable safety profiles in Alzheimer's and Parkinson's Disease trials.
BioVie (NASDAQ: BIVI) ha presentato dati promettenti su bezisterim durante la 7ª Conferenza Mondiale sull'Invecchiamento e il Ringovanimento, evidenziando il suo potenziale nel rallentare l'invecchiamento biologico e la neurodegenerazione. L'analisi dello studio di Fase 3 NM101 ha mostrato che i pazienti con Alzheimer trattati con bezisterim hanno registrato una significativa riduzione dell'età biologica rispetto al placebo, misurata su diversi orologi epigenetici, con differenze comprese tra -1,38 e -4,24 anni.
Lo studio ha dimostrato la capacità di bezisterim di modulare l'infiammazione e l'attivazione genica, con miglioramenti significativi in biomarcatori chiave come -8,5 mg/dL nella glicemia a digiuno, -15 mg/dL nel colesterolo e -90,5 pg/mL in MCP. Bezisterim, una versione stabilizzata del Beta AET, si distingue per la sua disponibilità orale e la capacità di attraversare la barriera ematoencefalica, mantenendo profili di sicurezza favorevoli negli studi su Alzheimer e Parkinson.
BioVie (NASDAQ: BIVI) presentó datos prometedores sobre bezisterim en la 7ª Conferencia Mundial sobre Envejecimiento y Rejuvenecimiento, destacando su potencial para ralentizar el envejecimiento biológico y la neurodegeneración. El análisis del estudio de Fase 3 NM101 reveló que los pacientes con Alzheimer tratados con bezisterim mostraron una reducción significativa de la edad biológica en comparación con el placebo, según múltiples relojes epigenéticos, con diferencias que oscilaron entre -1,38 y -4,24 años.
El estudio demostró la capacidad de bezisterim para modular la inflamación y la activación génica, con mejoras significativas en biomarcadores clave, incluyendo -8,5 mg/dL en glucosa en ayunas, -15 mg/dL en colesterol y -90,5 pg/mL en MCP. Bezisterim, una versión estabilizada de Beta AET, ofrece disponibilidad oral y capacidad para atravesar la barrera hematoencefálica, manteniendo perfiles de seguridad favorables en ensayos para Alzheimer y Parkinson.
BioVie (NASDAQ: BIVI)는 제7회 세계 노화 및 회춘 컨퍼런스에서 베지스테림에 관한 유망한 데이터를 발표하며, 이 약물이 생물학적 노화와 신경퇴행을 늦출 잠재력을 강조했습니다. 3상 NM101 연구 분석 결과, 베지스테림을 투여받은 알츠하이머 환자들은 여러 후생유전학 시계를 기준으로 위약군에 비해 생물학적 나이가 -1.38년에서 -4.24년까지 유의미하게 감소한 것으로 나타났습니다.
이 연구는 베지스테림이 염증과 유전자 활성화를 조절하는 능력을 입증했으며, 투여 환자들은 공복 혈당 -8.5 mg/dL, 콜레스테롤 -15 mg/dL, MCP -90.5 pg/mL 등 주요 바이오마커에서 유의한 개선을 보였습니다. 베지스테림은 안정화된 베타 AET 버전으로, 경구 투여 가능하며 혈액-뇌 장벽을 통과하는 독특한 특성을 지니고 있으며, 알츠하이머 및 파킨슨병 임상시험에서 안전성 프로파일도 우수하게 유지되고 있습니다.
BioVie (NASDAQ : BIVI) a présenté des données prometteuses sur le bezisterim lors de la 7e Conférence mondiale sur le vieillissement et le rajeunissement, soulignant son potentiel à ralentir le vieillissement biologique et la neurodégénérescence. L'analyse de l'étude de phase 3 NM101 a révélé que les patients atteints d'Alzheimer traités par bezisterim présentaient une réduction significative de l'âge biologique par rapport au placebo, mesurée sur plusieurs horloges épigénétiques, avec des différences allant de -1,38 à -4,24 ans.
L'étude a démontré la capacité du bezisterim à moduler l'inflammation et l'activation génétique, les patients traités montrant des améliorations significatives de biomarqueurs clés, notamment -8,5 mg/dL de glucose à jeun, -15 mg/dL de cholestérol et -90,5 pg/mL de MCP. Le bezisterim, une version stabilisée du Beta AET, offre une disponibilité orale et une capacité à traverser la barrière hémato-encéphalique, tout en conservant un profil de sécurité favorable dans les essais sur la maladie d'Alzheimer et de Parkinson.
BioVie (NASDAQ: BIVI) präsentierte vielversprechende Daten zu Bezisterim auf der 7. Weltkonferenz für Altern und Verjüngung und hob dessen Potenzial hervor, das biologische Altern und die Neurodegeneration zu verlangsamen. Die Analyse der Phase-3-Studie NM101 zeigte, dass Alzheimer-Patienten, die mit Bezisterim behandelt wurden, im Vergleich zu Placebo eine signifikante Reduktion des biologischen Alters über mehrere epigenetische Uhren hinweg aufwiesen, mit Unterschieden von -1,38 bis -4,24 Jahren.
Die Studie bewies die Fähigkeit von Bezisterim, Entzündungen und Genaktivierung zu modulieren, wobei behandelte Patienten signifikante Verbesserungen bei wichtigen Biomarkern zeigten, darunter -8,5 mg/dL beim Nüchternblutzucker, -15 mg/dL beim Cholesterin und -90,5 pg/mL bei MCP. Bezisterim, eine stabilisierte Version von Beta AET, bietet als einziges Medikament orale Verfügbarkeit und die Fähigkeit, die Blut-Hirn-Schranke zu überwinden, während es in Studien zu Alzheimer und Parkinson ein günstiges Sicherheitsprofil aufweist.
- Multiple epigenetic clocks showed significant biological age reduction in treated patients
- Significant improvements in metabolic and inflammatory biomarkers
- Drug demonstrates ability to cross blood-brain barrier with favorable safety profile
- Unique oral formulation overcomes limitations of natural Beta AET
- Phase 3 analysis based on relatively small sample size (n=33)
- Some epigenetic clock measurements did not reach statistical significance (GrimAge p=0.148)
Insights
BioVie's bezisterim shows promise in slowing biological aging markers in Alzheimer's patients through anti-inflammatory mechanisms.
BioVie has presented intriguing data for bezisterim, their Alzheimer's drug candidate, showing potential to slow or reverse biological aging processes. The analysis of their Phase 3 study reveals that bezisterim-treated patients demonstrated significantly younger biological age compared to placebo across multiple validated epigenetic clocks – with differences ranging from
What makes this approach particularly noteworthy is bezisterim's mechanism of action. Rather than targeting single pathways like amyloid or tau (which have largely failed in Alzheimer's treatment), bezisterim modulates inflammation and appears to make small changes across many genes simultaneously. This multi-target approach addresses the complex nature of neurodegeneration more comprehensively.
The drug showed statistically significant improvements in key biomarkers: reduced fasting glucose (
Bezisterim itself is a stabilized version of Beta AET, addressing critical limitations of the natural compound which cannot be taken orally. This drug can cross the blood-brain barrier while maintaining metabolic stability – essential properties for CNS therapeutics. Importantly, it exhibits anti-inflammatory effects without immunosuppression, a critical safety advantage for chronic treatment in elderly patients.
While these results represent a subset analysis from their Phase 3 trial rather than the primary endpoints, they provide mechanistic support for bezisterim's potential efficacy in Alzheimer's and possibly other age-related conditions. The focus on biological aging as a therapeutic target represents an innovative approach to addressing neurodegenerative disease.
CARSON CITY, Nev., July 09, 2025 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, presented “Bezisterim Epigenetic Effects on Aging and Neurodegeneration” at the 7th World Aging and Rejuvenation Conference (ARC-2025) taking place in Vienna, Austria, July 9th –10th, 2025.
Unlike historical approach to Alzheimer’s Disease (AD) treatment that focuses on changing one gene product (e.g., amyloid, p-Tau) at a time, bezisterim modulates inflammation and is believed to help reestablish homeostasis and small changes in many genes at the same time. The data suggest that bezisterim may alter biological age by anti-inflammatory epigenetic modifications. Epigenetic biomarkers can measure “Epigenetic Age Acceleration” (EAA), which is defined as the difference between observed biological age as measured by DNA methylation and the chronological age (i.e., years since birth).
An analysis of the Company’s Phase 3 NM101 study (NCT04669028) evaluating bezisterim in patients with mild-to-moderate probable AD assessed 33 blood samples of patients treated with bezisterim (n = 17) and placebo (n = 16) using five validated epigenetic “biological” clocks that analyze genes linked to aging, as well as age-related inflammatory markers. In this analysis, treatment with bezisterim demonstrated:
- Biological Aging Effects. After 30 weeks of treatment, the average difference between the placebo and bezisterim groups was −3.16 years for SBCAge (p = 0.036), −4.12 years for PhenoAge (p = 0.048), −1.38 years for GrimAge (p = 0.148), −4.24 years for Hannum clock (p = 0.015), and −3.77 years for InflammAge (p = 0.050). The various “biological clocks” measure the extent of age deceleration1 advantage bezisterim-treated patients have compared to those treated with placebo.
- Gene modulation effects. Bezisterim-treated patients experienced decreased activation of various genes associated with inflammatory kinase cascades, aging and cognition, leading to potentially beneficial changes in aging and AD pathophysiology.
- Metabolic and inflammatory biomarker effects. Bezisterim-treated experienced significant improvements from baseline on metabolic and inflammatory biomarkers compared to those treated with placebo, including -8.5 mg/dL on fasting glucose (p=0.036), -15 mg/dL in cholesterol (p=0.049), and -90.5 pg/mL in MCP (p=0.007). Bezisterim-treated patients also experienced a decrease in carbohydrate metabolism, glycolysis, and Type 2 diabetes pathophysiology.
“Biological aging is the single greatest risk factor for the development of dementia, and we believe our work with bezisterim represents a promising strategy to target the underlying mechanisms of neurodegeneration,” said Christopher Reading, PhD, Senior Vice President of BioVie’s Alzheimer’s Program. “We are honored to share these data that may illuminate bezisterim’s potential to target epigenetic-driven age acceleration as a treatment for Alzheimer’s and other neurodegenerative diseases of aging. We are conducting ongoing studies to further explore these intriguing findings and how bezisterim may help everyone improve healthspan in normal aging.”
Bezisterim is a unique, stabilized version of Beta AET, a naturally occurring brain metabolite of dehydroepiandrosterone (DHEA), which has demonstrated anti-inflammatory and immunomodulating activity in humans, but that naturally decreases with age. Beta AET itself cannot be taken in oral form, a major limitation that Bezisterim may address. Unlike its naturally occurring counterpart, Bezisterim is metabolically stable, orally available, and able to cross the blood-brain barrier. It has demonstrated anti-inflammatory effects through inhibition of NF-kappa B, a central mediator of inflammation, and has shown insulin-sensitizing properties. Notably, Bezisterim is not immunosuppressive, and has demonstrated favorable safety and tolerability profiles across in-vivo clinical trials in AD and Parkinson’s Disease (PD).
About Bezisterim
Bezisterim (NE3107) is an orally bioavailable, blood-brain barrier (BBB)-permeable modulator of inflammation and insulin-sensitizer. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. By binding to ERK and selectively modulating NFκB activation and TNF-α production, BioVie believes that bezisterim may offer clinical improvements in several disease indications, including Alzheimer’s disease, Parkinson’s disease and long COVID.
In Parkinson’s disease, BioVie is currently enrolling patients in the Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim on motor and non-motor symptoms in patients who have not been treated with carbidopa/levodopa, with topline data expected in late 2025 or early 2026. A previous Phase 2 study of bezisterim in Parkinson’s disease (NCT05083260) completed in 2022, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023, showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of bezisterim and levodopa versus patients treated with levodopa alone, and no drug-related adverse events.
In long COVID, bezisterim has the potential to reduce neurological symptoms, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFκB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). BioVie’s Phase 2 ADDRESS-LC study, is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety, tolerability and potential efficacy of 3 months of treatment with bezisterim to reduce the neurocognitive symptoms associated with long COVID, including difficulty concentrating or remembering things (“brain fog”) and fatigue.
In Alzheimer’s disease, BioVie conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate Alzheimer’s disease (NCT04669028) in 2023. Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from Alzheimer’s disease.
About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (AD, Parkinson’s disease and long COVID) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor nuclear factor-κB, and the associated neuroinflammation and insulin resistance but not ERK and NFκB homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance are drivers of AD and PD. Persistent systematic inflammation and neuroinflammation are key features in patients with neurological symptoms of long COVID. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. 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" 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 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, 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:
Chuck Padala
LifeSci Advisors, LLC
chuck@lifesciadvisors.com
For Media Inquiries:
Melyssa Weible
Elixir Health Public Relations
mweible@elixirhealthpr.com
1 Defined as the difference between observed biological age as measured by DNA methylation and the chronological age (i.e., years since birth).
FAQ
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