BioVie to Host KOL Investor Webcast to Discuss the Long COVID Treatment Landscape and its ADDRESS-LC Trial on April 10, 2025
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 Inc. (NASDAQ: BIVI) ha annunciato un evento virtuale per investitori programmato per il 10 aprile 2025, alle 10:00 AM ET, con la partecipazione della Key Opinion Leader Dr. Lindsay McAlpine dell'Università di Yale. Il webcast si concentrerà sul panorama del trattamento del long COVID e fornirà aggiornamenti sul trial ADDRESS-LC di BioVie.
Il trial valuta bezisterim (NE3107), un nuovo agente anti-infiammatorio orale e sensibilizzante all'insulina in grado di attraversare la barriera emato-encefalica. Il farmaco inibisce selettivamente i mediatori infiammatori stimolati da ERK e NF-κB indotti dall'infiammazione, preservando al contempo le loro funzioni omeostatiche. La discussione affronterà come la neuroinfiammazione cronica, potenzialmente causata dalla persistenza della proteina spike virale, possa spiegare la persistenza dei sintomi del long COVID.
BioVie Inc. (NASDAQ: BIVI) anunció un evento virtual para inversores programado para el 10 de abril de 2025, a las 10:00 AM ET, con la participación de la Líder de Opinión Clave, la Dra. Lindsay McAlpine de la Universidad de Yale. El webcast se centrará en el panorama del tratamiento del long COVID y proporcionará actualizaciones sobre el ensayo ADDRESS-LC de BioVie.
El ensayo evalúa bezisterim (NE3107), un nuevo agente antiinflamatorio oral y sensibilizador de insulina que puede cruzar la barrera hematoencefálica. El fármaco inhibe selectivamente los mediadores inflamatorios estimulados por ERK y NF-κB mientras preserva sus funciones homeostáticas. La discusión abordará cómo la neuroinflamación crónica, potencialmente causada por la persistencia de la proteína espiga viral, puede explicar la persistencia de los síntomas del long COVID.
BioVie Inc. (NASDAQ: BIVI)는 2025년 4월 10일 오전 10시(동부 표준시)에 예일 대학교의 주요 의견 리더인 린지 맥알파인 박사를 초청하여 예정된 가상 투자자 이벤트를 발표했습니다. 이 웹캐스트는 롱 COVID 치료 환경에 초점을 맞추고 BioVie의 ADDRESS-LC 시험에 대한 업데이트를 제공합니다.
이 시험은 베지스터림 (NE3107)을 평가하며, 이는 혈액-뇌 장벽을 통과할 수 있는 새로운 경구 항염증제 및 인슐린 감작제입니다. 이 약물은 염증에 의해 유도된 ERK 및 NF-κB 자극 염증 매개체를 선택적으로 억제하면서 그들의 항상성 기능을 보존합니다. 논의에서는 지속적인 바이러스 스파이크 단백질로 인해 발생할 수 있는 만성 신경 염증이 롱 COVID 증상의 지속성을 설명할 수 있는 방법에 대해 다룰 것입니다.
BioVie Inc. (NASDAQ: BIVI) a annoncé un événement virtuel pour les investisseurs prévu le 10 avril 2025 à 10h00 ET, avec la participation de la Leader d'Opinion Clé, Dr. Lindsay McAlpine de l'Université de Yale. Le webcast se concentrera sur le paysage du traitement du long COVID et fournira des mises à jour sur l'essai ADDRESS-LC de BioVie.
L'essai évalue bezisterim (NE3107), un nouvel agent anti-inflammatoire oral et sensibilisant à l'insuline capable de traverser la barrière hémato-encéphalique. Le médicament inhibe sélectivement les médiateurs inflammatoires stimulés par ERK et NF-κB, tout en préservant leurs fonctions homéostatiques. La discussion portera sur la manière dont la neuroinflammation chronique, potentiellement causée par la persistance de la protéine spike virale, pourrait expliquer la persistance des symptômes du long COVID.
BioVie Inc. (NASDAQ: BIVI) hat eine virtuelle Investorenveranstaltung für den 10. April 2025, um 10:00 Uhr ET, angekündigt, die von der Key Opinion Leader Dr. Lindsay McAlpine von der Yale University geleitet wird. Das Webcast wird sich auf die Behandlungslandschaft von Long COVID konzentrieren und Updates zu BioVies ADDRESS-LC-Studie bereitstellen.
Die Studie bewertet bezisterim (NE3107), ein neuartiges orales entzündungshemmendes und insulin-sensibilisierendes Mittel, das die Blut-Hirn-Schranke überwinden kann. Das Medikament hemmt selektiv entzündungsgesteuerte ERK- und NF-κB-stimulierte Entzündungsmediatoren, während es deren homöostatische Funktionen bewahrt. Die Diskussion wird sich damit befassen, wie chronische Neuroentzündungen, die möglicherweise durch persistierende virale Spike-Proteine verursacht werden, die Persistenz der Symptome von Long COVID erklären können.
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CARSON CITY, Nev., March 27, 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, today announced that it will host a virtual investor event featuring key opinion leader (KOL) Lindsay McAlpine, MD, BSc (Yale University), who will join company management to discuss the unmet need and current treatment landscape for long COVID on Thursday, April 10, 2025 at 10:00 AM ET. To register, click here.
The event will provide an update on BioVie's ADDRESS-LC trial evaluating bezisterim (NE3107) for the treatment of long COVID. Bezisterim is a novel, oral, blood-brain barrier–permeable, anti-inflammatory, insulin-sensitizing agent that has shown to selectively inhibit inflammation-driven ERK- and NF-κB-stimulated inflammatory mediators, without inhibiting their homeostatic functions. Chronic neuroinflammation, potentially driven by persisting viral spike protein1,2, is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.
A live question and answer session will follow the formal presentations.
About Lindsay McAlpine, MD, BSc
Lindsay McAlpine, MD, BSc, is a neuroimmunologist in Division of Neurological Infections and Global Neurology at the Yale University School of Medicine. She founded the NeuroCOVID Clinic at Yale in October 2020 and now directs the clinic. She sees patients with neurologic issues related to Long COVID and patients with multiple sclerosis and autoimmune disorders of the nervous system. She is an investigator in the COVID Mind Study at Yale, and her research interests are related to the pathophysiology of neurologic symptoms after COVID-19 using several modalities, including MRI.
About Long COVID
Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. Common symptoms include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory problems, muscle weakness, and neurologic issues have also been documented. The Centers for Disease Control recently reported that
About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Long COVID, Alzheimer's disease and Parkinson’s disease) 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-kB, and the associated neuroinflammation and insulin resistance but not ERK and NFkB 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.
References
1Rong Z, Mai H, Ebert G, Kapoor S, Puelles VG, Czogalla J, Hu S, Su J, Prtvar D, Singh I, Schädler J, Delbridge C, Steinke H, Frenzel H, Schmidt K, Braun C, Bruch G, Ruf V, Ali M, Sühs KW, Nemati M, Hopfner F, Ulukaya S, Jeridi D, Mistretta D, Caliskan ÖS, Wettengel JM, Cherif F, Kolabas ZI, Molbay M, Horvath I, Zhao S, Krahmer N, Yildirim AÖ, Ussar S, Herms J, Huber TB, Tahirovic S, Schwarzmaier SM, Plesnila N, Höglinger G, Ondruschka B, Bechmann I, Protzer U, Elsner M, Bhatia HS, Hellal F, Ertürk A. Persistence of spike protein at the skull-meninges-brain axis may contribute to the neurological sequelae of COVID-19. Cell Host Microbe. 2024 Dec 11;32(12):2112-2130.e10.
2Frank MG, Nguyen KH, Ball JB, Hopkins S, Kelley T, Baratta MV, Fleshner M, Maier SF. SARS-CoV-2 spike S1 subunit induces neuroinflammatory, microglial and behavioral sickness responses: Evidence of PAMP-like properties. Brain Behav Immun. 2022 Feb;100:267-277.
3Ford ND, Agedew A, Dalton AF, Singleton J, Perrine CG, Saydah S. Notes from the Field: Long COVID Prevalence Among Adults — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:135–136. DOI: http://dx.doi.org/10.15585/mmwr.mm7306a4.
4Azhir A et al. “Precision Phenotyping for Curating Research Cohorts of Patients with Unexplained Post-Acute Sequelae of COVID-19” Med DOI: 10.1016/j.medj.2024.10.009, in press
5Cutler, David M. 2022 The economic costs of Long COVID: An update. long_covid_update_7-22.pdf (harvard.edu)
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:
Bruce Mackle
Managing Director, LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
For Media Relations Inquiries:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com
FAQ
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