{"id":863354,"date":"2025-06-24T16:08:45","date_gmt":"2025-06-24T20:08:45","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/"},"modified":"2025-06-24T16:08:45","modified_gmt":"2025-06-24T20:08:45","slug":"biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/","title":{"rendered":"BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress"},"content":{"rendered":"
\n

CARSON CITY, Nev., June 24, 2025 (GLOBE NEWSWIRE) — BioVie Inc., (NASDAQ: BIVI) (\u201cBioVie\u201d or the \u201cCompany\u201d) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease,\u00a0today announced that a poster highlighting the decentralized design and patient experience of its Phase 2 SUNRISE-PD<\/a> clinical trial evaluating bezisterim (NE3107) in early Parkinson\u2019s disease will be presented in poster session at the upcoming Advanced Therapeutics in Movement & Related Disorders\u00ae Congress<\/em><\/a>, to be held at National Harbor, MD, from June 27 to June 30, 2025.<\/p>\n

Details for the poster session are as follows:<\/p>\n

\n Title:<\/strong>
\n SUNRISE-PD: An Ongoing, Hybrid, Decentralized Phase 2 Study of Bezisterim (NE3107) in Early Parkinson\u2019s Disease<\/em>
\n
\n Poster session: <\/strong>11:30am to 12:30pm, Friday June 27
Authors: <\/strong>Mark Stacy; Clarence Ahlem; Christopher L. Reading; Jeffrey Zhang; Joseph M. Palumbo
Poster position: <\/strong>P 49
Poster displayed <\/strong>from 7:00am Friday June 27 through 2:00pm Sunday June 29<\/p>\n

SUNRISE-PD is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design that will last 20 weeks from the initial screening phase to the safety follow up.<\/p>\n

As part of the trial, patients may participate either completely from their home or at a clinical site. At-home participants will be visited by study nurses who will complete study assessments with the assistance of a neurologist who will attend the visit remotely by video and supervise administration of a modified MDS-UPDRS Part III examination, which will be recorded for review and scoring by a central rating committee. If the trial’s results are positive, participants may be eligible to enter a longer-term, open-label safety study.<\/p>\n

\n About Parkinson\u2019s Disease<\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
Parkinson\u2019s disease (PD) is a progressive neurodegenerative disorder that primarily affects movement. It is characterized by the loss of dopamine-producing neurons in the substantia nigra, a region of the brain critical for motor control. Core symptoms include tremors, muscle rigidity, bradykinesia (slowness of movement), postural instability, and difficulties with speech.1-2<\/sup> Non-motor symptoms, such as cognitive impairment, mood disorders, and autonomic dysfunction, also significantly impact patients’ quality of life.3<\/sup> In the early stages, symptoms are often mild and may include subtle tremors, slight movement difficulties, and changes in handwriting or facial expressions. As the disease progresses, motor symptoms become more pronounced, leading to difficulties with balance, speech, and daily activities, often requiring full-time care in later stages.4<\/sup><\/p>\n

Since the 1960s, when dopamine\u2019s critical role in Parkinson\u2019s disease was first identified, levodopa has remained the cornerstone of treatment, providing significant symptom relief by replenishing dopamine levels in the brain.5-6<\/sup> However, long-term use is associated with complications such as motor fluctuations\u2014where symptom control becomes less stable\u2014and dyskinesia, involuntary movements that can become debilitating.7-9<\/sup><\/p>\n

Emerging research highlights the role of chronic inflammation and insulin resistance in the onset and progression of Parkinson\u2019s disease. Neuroinflammation, driven by activated microglia and elevated levels of pro-inflammatory cytokines, contributes to oxidative stress and accelerates neuronal degeneration.10-12<\/sup> Additionally, insulin resistance, which impairs the brain\u2019s ability to regulate glucose metabolism, has been linked to increased neurodegeneration and worsening motor symptoms.13-14<\/sup> These metabolic dysfunctions create a harmful cycle that exacerbates disease progression, underscoring the potential of anti-inflammatory and insulin-sensitizing therapies as new avenues for treatment.<\/p>\n

\n About Bezisterim<\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
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 NF\u03baB activation and TNF-\u03b1 production, BioVie believes that bezisterim may offer clinical improvements in several disease indications, including Alzheimer\u2019s disease, Parkinson\u2019s disease and long COVID.<\/p>\n

In Parkinson\u2019s disease, BioVie is currently enrolling patients in the Phase 2 SUNRISE-PD<\/a> 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\u2019s disease (NCT05083260) completed in 2022, and data presented at the AD\/PD\u2122 2023 International Conference on Alzheimer\u2019s and Parkinson\u2019s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023 showed significant improvements in \u201cmorning on\u201d 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.<\/p>\n

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 NF\u03baB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). BioVIe\u2019s Phase 2 ADDRESS-LC<\/a> 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 (\u201cbrain fog\u201d) and fatigue.<\/p>\n

In Alzheimer\u2019s 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\u2019s 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\u2019s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from Alzheimer\u2019s disease.<\/p>\n

\n About BioVie Inc.<\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Alzheimer\u2019s disease, Parkinson\u2019s disease and long COVID) and advanced liver disease. In neurodegenerative disease, the Company\u2019s drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor nuclear factor-\u03baB, and the associated neuroinflammation and insulin resistance but not ERK and NF\u03baB 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\u2019s 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<\/a>.<\/p>\n

\n Forward-Looking Statements<\/strong>\u00a0<\/p>\n

\n 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.<\/em>\n <\/p>\n

\n References<\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
1 Cleveland Clinic. Parkinson\u2019s Disease. Last reviewed: 2022 Apr 15.
2 Jankovic J. J Neurol Neurosurg Psychiatry. 2008;79(4):368-376.
3 Postuma RB, Berg D, Stern M, et al. Mov Disord. 2015;30(12):1591-1601.
4 Kalia LV and Lang AE. Lancet. 2015;386(9996):896-912.
5 Hornykiewicz O. Angew Chem Int Ed. 2002;41(17):2934-2941.
6 Olanow CW, Obeso JA and Stocchi F. Lancet Neurol. 2006;5(8):677-687.
7 Ahlskog JE and Muenter MD. Mov Disord. 2001;16(3):448-458.
8 Espay AJ, Morgante F, Merola A, et al. Ann Neurol. 2018;84(6):797-811.
9 Cilia R and Akpalu A. J Neural Transm. 2020;127(5):889-916.
10 Jurcau A, Andronie-Cioara FL, Nistor-Cseppento DC, et al. Int J Mol Sci. 2023;24:14582.
11 Pajares M, Rojo AI, Manda G, et al. Cells. 2020;9:1687.
12 Isik S, Kiyak BY, Akbayir R, et al. Cells. 2023;12:1012.
13 Zagare A, Hemedan A, Almeida C, et al. Mov Disord. 2025;40(1):67-76.
14 Ruiz-Pozo VA, Tamayo-Trujillo R, Cadena-Ullauri S, et al. Nutrients. 2023;15(16):3585.<\/p>\n

\n
\n For Investor Relations Inquiries:<\/em>
\n <\/strong>\u00a0<\/p>\n

Contact:\u00a0
Chuck Padala<\/strong>\u00a0
Managing Director<\/em>\u00a0
LifeSci Advisors, LLC<\/strong>\u00a0
chuck@lifesciadvisors.com<\/u><\/a>\u00a0<\/u><\/p>\n

\n
\n For Media Inquires<\/em>
\n <\/strong>
\n
\n Melyssa Weible<\/strong>
\n
\n Managing Partner, Elixir Health Public Relations\u00a0<\/em>
\n
Ph: +1 201-723-5705
mweible@elixirhealthpr.com<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

CARSON CITY, Nev., June 24, 2025 (GLOBE NEWSWIRE) — BioVie Inc., (NASDAQ: BIVI) (\u201cBioVie\u201d or the \u201cCompany\u201d) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease,\u00a0today announced that a poster highlighting the decentralized design and patient experience of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson\u2019s disease will be presented in poster session at the upcoming Advanced Therapeutics in Movement & Related Disorders\u00ae Congress, to be held at National Harbor, MD, from June 27 to June 30, 2025. Details for the poster session are as follows: Title: SUNRISE-PD: An Ongoing, Hybrid, Decentralized Phase 2 Study of Bezisterim (NE3107) in Early Parkinson\u2019s Disease Poster session: 11:30am to … <\/p>\n

Continue reading “BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-863354","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nBioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CARSON CITY, Nev., June 24, 2025 (GLOBE NEWSWIRE) — BioVie Inc., (NASDAQ: BIVI) (\u201cBioVie\u201d or the \u201cCompany\u201d) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease,\u00a0today announced that a poster highlighting the decentralized design and patient experience of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson\u2019s disease will be presented in poster session at the upcoming Advanced Therapeutics in Movement & Related Disorders\u00ae Congress, to be held at National Harbor, MD, from June 27 to June 30, 2025. Details for the poster session are as follows: Title: SUNRISE-PD: An Ongoing, Hybrid, Decentralized Phase 2 Study of Bezisterim (NE3107) in Early Parkinson\u2019s Disease Poster session: 11:30am to … Continue reading "BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-24T20:08:45+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4Mzc3NCM3MDE2MjIwIzUwMDA3OTY2Ng==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress\",\"datePublished\":\"2025-06-24T20:08:45+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\\\/\"},\"wordCount\":1451,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ4Mzc3NCM3MDE2MjIwIzUwMDA3OTY2Ng==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\\\/\",\"name\":\"BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress - 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Details for the poster session are as follows: Title: SUNRISE-PD: An Ongoing, Hybrid, Decentralized Phase 2 Study of Bezisterim (NE3107) in Early Parkinson\u2019s Disease Poster session: 11:30am to … Continue reading \"BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/","og_site_name":"Market Newsdesk","article_published_time":"2025-06-24T20:08:45+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4Mzc3NCM3MDE2MjIwIzUwMDA3OTY2Ng==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress","datePublished":"2025-06-24T20:08:45+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/"},"wordCount":1451,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4Mzc3NCM3MDE2MjIwIzUwMDA3OTY2Ng==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/biovie-to-present-overview-of-phase-2-sunrise-pd-trial-at-the-advanced-therapeutics-in-movement-related-disorders-congress\/","name":"BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders\u00ae Congress - 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