Triolex (bezisterim) / Harbor Biosci, BioVie - LARVOL DELTA

Join Biovie’s Exclusive Live Investor Webinar and Q&A Session on December 9 (GlobeNewswire) - "The exclusive event, hosted by RedChip Companies, will feature Cuong Do, President and CEO of BioVie, who will discuss bezisterim (NE3107), BioVie’s first-in-class, orally available small molecule that targets inflammation and insulin resistance, two key drivers of Alzheimer’s, Parkinson’s, and Long COVID, where it has shown encouraging signals of improved cognition, motor function, and reduced neuroinflammation across clinical studies. He will also outline progress with BIV201, BioVie’s late-stage orphan drug candidate for refractory ascites, a life-threatening complication of liver cirrhosis with no FDA-approved therapies."

Clinical • Alzheimer's Disease • Gastrointestinal Disorder • Novel Coronavirus Disease • Parkinson's Disease

BioVie to Host Live Investor Webinar and Q&A on Oct. 8 (GlobeNewswire) - "The exclusive event, hosted by RedChip Companies, will feature Cuong Do, president and CEO of BioVie, who will discuss bezisterim (NE3107), the company’s first-in-class, orally available small molecule that targets inflammation and insulin resistance, two key drivers of Alzheimer’s, Parkinson’s, and long COVID....Do will also outline progress with BIV201, BioVie’s late-stage orphan drug candidate for refractory ascites, a life-threatening complication of liver cirrhosis that currently has no FDA-approved therapies."

Clinical • Alzheimer's Disease • Liver Cirrhosis • Novel Coronavirus Disease • Parkinson's Disease

Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Neurological Associates of West Los Angeles | The participant's caregiver requested for the participant to be withdrawn from the study. The investigator has decided to close out.

Trial primary completion date • Trial termination • CNS Disorders • Fatigue • Vascular Neurology

BioVie Presented Data Highlighting that Patients Treated with Bezisterim Potentially Experienced an Age Deceleration Advantage Compared to Placebo on 10 Different Biological Clocks at the 2nd World Conference on Aging and Gerontology (BioVie Press Release) - P3 | N=439 | NCT04669028 | Sponsor: BioVie Inc. | "An analysis of the Company’s Phase 3 NM101 study (NCT04669028) evaluating bezisterim in patients with mild-to-moderate probable Alzheimer’s Disease (AD) assessed 33 blood samples of patients treated with bezisterim (n = 17) and placebo (n = 16) revealed: Biological aging. After 30 weeks of treatment, bezisterim-treated patients experienced significant age deceleration compared to placebo-treated patients on all biological clocks assessed, including −3.16 years for SkinBloodClockAge (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); Inflammatory gene expression. Bezisterim appeared to modulate gene expression of dozens of genes in the inflammatory cascade (e.g., NFkB, MAP, JNK), resulting in reduced expression of inflammatory..."

P3 data • Alzheimer's Disease

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 (Businesswire) - P3 | N=439 | NCT04669028 | Sponsor: BioVie Inc. | "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 deceleration advantage bezisterim-treated patients have compared to those treated with placebo."

P3 data • Alzheimer's Disease

BioVie Highlights Patient-Centric Design of SUNRISE-PD Trial at Advanced Therapeutics in Movement & Related Disorders Congress (ATMRD) (GlobeNewswire) - "ioVie Inc...announced that a poster highlighting the patient-centric design and accessibility of its ongoing SUNRISE-PD Phase 2 clinical trial will be presented at the Advanced Therapeutics in Movement & Related Disorders Congress, to be held at National Harbor, MD, from June 27-30, 2025...SUNRISE-PD is a Phase 2 trial evaluating bezisterim (NE3107) in individuals with early-stage PD that aims to address these challenges through a hybrid, decentralized design....The study’s flexible design includes in-home visits conducted by study nurses with neurologist oversight via video conferencing and remote assessment of motor symptoms using a modified MDS-UPDRS Part III scale evaluated by a centralized rating committee. All data collection is supported by digital tools and virtual documentation to ensure consistency, quality, and ease of use for participants."

Clinical protocol • Trial status • Parkinson's Disease

BioVie to Present Overview of Phase 2 SUNRISE-PD Trial at the Advanced Therapeutics in Movement & Related Disorders Congress (GlobeNewswire) - "BioVie...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’s disease will be presented in poster session at the upcoming Advanced Therapeutics in Movement & Related Disorders Congress, to be held at National Harbor, MD, from June 27 to June 30, 2025....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."

P2b data • Parkinson's Disease

BioVie to Host Virtual KOL Event to Discuss the Phase 2 Study of Bezisterim for the Treatment of Parkinson's Disease on May 28, 2025 (GlobeNewswire) - "The event will provide an update on BioVie's Phase 2 trial (SUNRISE-PD; sunrisepd.com) evaluating bezisterim (NE3107) for the treatment of Parkinson's disease."

P2b data • Parkinson's Disease

BioVie to Present Rationale and Design of Phase 2 SUNRISE-PD Clinical Trial at the 30th World Congress on Parkinson’s Disease and Related Disorders (IAPRD 2025) (GlobeNewswire) - "BioVie Inc...today announced that a poster on the rationale and design of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson’s disease will be presented in a Guided Poster Tour session at the 30th World Congress on Parkinson’s Disease and Related Disorders (IAPRD 2025), being held May 7-10, 2025, in New York City."

P2b data • Parkinson's Disease

ADdRESs-LC: NE3107 in Adults With Long COVID (clinicaltrials.gov) - P2 | N=208 | Recruiting | Sponsor: BioVie Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Novel Coronavirus Disease

BioVie Initiates SUNRISE-PD Clinical Trial Assessing Bezisterim in Early Parkinson’s Disease with First Patient Enrolled (GlobeNewswire) - "BioVie Inc...announced that patient enrollment is now open for the Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in patients with Parkinson’s disease (PD) who haven’t been treated with carbidopa/levodopa. The first patient in the trial has been enrolled, and the Company anticipates topline data to be available in late 2024 or early 2025."

Enrollment open • P2 data • Parkinson's Disease

BioVie to Host KOL Investor Webcast to Discuss the Long COVID Treatment Landscape and its ADDRESS-LC Trial on April 10, 2025 (GlobeNewswire) - "BioVie Inc...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....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."

Trial status • Novel Coronavirus Disease

ADdRESs-LC: NE3107 in Adults with Long COVID (clinicaltrials.gov) - P2 | N=208 | Not yet recruiting | Sponsor: BioVie Inc.

New P2 trial • Novel Coronavirus Disease

SUNRISE-PD: A Study of NE3107 in Early Parkinson's (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: BioVie Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

SUNRISE-PD: A Study of NE3107 in Early Parkinson's (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: BioVie Inc.

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

BioVie’s Upcoming Parkinson’s Disease Clinical Trial is Fully Funded (GlobeNewswire) - "BioVie Inc...is pleased to announce that the upcoming PD-202 A Double-Blind, Randomized, Placebo-controlled, Study of Bezisterim in Subjects with Early Parkinson’s Disease is now fully funded. Favorable capital market conditions last week enabled the company to raise over $15 million from secondary offerings, and the proceeds allow the Company to fund fully the costs of this upcoming clinical trial. The trial is expected to start in early 2025, and topline results are expected by late 2025...The Company's strategic priorities include launching a Phase 2 trial for PD in early 2025...and initiating a Phase 3 trial for AD in late 2025 with a new once-daily formulation of bezisterim."

Financing • New P2 trial • New P3 trial • New trial • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

New insights in lipid metabolism: potential therapeutic targets for the treatment of Alzheimer's disease. (PubMed, Front Neurosci) - "Ongoing clinical trials are investigating the efficacy of these strategies, including the use of ketogenic diets, statin therapy, and novel compounds like NE3107. The implications of these findings suggest that targeting lipid metabolism could offer new avenues for the treatment and management of AD. By concentrating on alterations in lipid metabolism within the central nervous system and their contribution to AD development, this review aims to shed light on novel research directions and treatment approaches for combating AD, offering hope for the development of more effective management strategies."

Journal • Review • Alzheimer's Disease • CNS Disorders • Metabolic Disorders • APOE

BioVie to Present Overview of Bezisterim Clinical Data on Longevity at 11th Aging Research and Drug Discovery Meeting (GlobeNewswire) - "The presentation 'Bezisterim Effects on Biological Age, Alzheimer’s Epigenetics, and Neurologic Assessments' will provide an overview of clinical data to-date on bezisterim, focusing on various analyses and measurements related to longevity and its ability to affect the biological aging process."

Clinical data • Alzheimer's Disease • CNS Disorders

BioVie Announces Alignment with FDA on Clinical Trial to Assess Bezisterim in Parkinson’s Disease (GlobeNewswire) - "BioVie Inc...today announced that it has achieved alignment with the Food and Drug Administration (FDA) on its upcoming SUNRISE-PD trial in Parkinson’s disease ('PD'). As a result, the Company is conducting trial start-up activities with a view to initiate patient screening in Q4 2024."

FDA event • Trial status • CNS Disorders • Parkinson's Disease

A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias. (PubMed, Medicine (Baltimore)) - "Our results indicate that in this study NE3107 was associated with what appear to be positive neurophysiological and neuropsychological findings, as well as evidence of improvement in biomarkers associated with neuroinflammation and AD in patients diagnosed with dementia. Our findings are consistent with previous preclinical and clinical observations and highlight a central role of neuroinflammation in AD pathogenesis."

Journal • P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Aβ42 • CSF P-tau • TNFA

Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury (clinicaltrials.gov) - P2 | N=5 | Recruiting | Sponsor: Neurological Associates of West Los Angeles | Not yet recruiting ➔ Recruiting | Phase classification: P2a ➔ P2 | Trial completion date: Jul 2024 ➔ Jul 2025 | Initiation date: Aug 2023 ➔ Dec 2023 | Trial primary completion date: Jun 2024 ➔ Dec 2024

Enrollment open • Phase classification • Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Fatigue • Vascular Neurology

Excess mortality among individuals who have undergone addiction treatment: a study from Greenland. (PubMed, J Ethn Subst Abuse) - "Of the 3286 in treatment, 53.9% were women, with a median age of 37...This study found that individuals seeking treatment for addiction problems in Greenland had a higher mortality rate than the general population. Importantly, these SMRs were substantially lower than those observed in clinical populations in other countries."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry

BioVie Presents Protocol Design of Upcoming SUNRISE-PD Phase 2 Trial of Bezisterim in Patients with Early Parkinson’s Disease at ATMRD 2024 (GlobeNewswire) - "BioVie Inc...today announced data from two presentations at the Advanced Therapeutics in Movement and Related Disorders Congress (ATMRD Congress) held June 21-25, 2024 in Washington, D.C. Presentations include a first look at the protocol design of the upcoming SUNRISE-PD Phase 2 trial of bezisterim (NE3107) in patients with early Parkinson’s disease along with an encore presentation of detailed results from the Company’s Phase 2a trial of bezisterim adjunctive to carbidopa/levodopa (C/L) in patients with Parkinson’s disease."

Clinical protocol • P2a data • CNS Disorders • Parkinson's Disease

IMPROVEMENT OF MOTOR AND NON-MOTOR SYMPTOMS WITH BEZISTERIM (NE3107) ADJUNCTIVE TO CARBIDOPA/LEVODOPA IN PATIENTS WITH PARKINSON’S DISEASE: A PHASE 2A, PLACEBO-CONTROLLED STUDY (ATMRD 2024) - No abstract available.

P2a data

BioVie to Present Protocol Design for Upcoming Phase 2 Trial of Bezisterim in Patients with Early Parkinson’s Disease at 2024 ATMRD Congress (GlobeNewswire) - "BioVie Inc...today announced two poster presentations at the Advanced Therapeutics in Movement and Related Disorders Congress (ATMRD Congress) being held June 21-25, 2024 in Washington, D.C...The presentation Assessment of Bezisterim (NE3107) in Patients with Early Parkinson’s Disease: A Phase 2, Placebo-Controlled Study will outline the study protocol of the Company’s upcoming Phase 2 trial evaluating bezisterim people with Parkinson’s disease who are naïve to carbidopa/levodopa treatment but in need of symptomatic therapy for motor symptoms...An additional presentation...will feature data that further characterizes the potential impact of bezisterim on motor and specific non-motor symptoms of Parkinson’s disease."

Clinical data • Clinical protocol • CNS Disorders • Parkinson's Disease