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

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

BioVie’s Bezisterim Demonstrates Potential Improvements in Sleep/Fatigue and Restless Leg Symptoms for Parkinson’s Disease Patients (GlobeNewswire) - P1/2 | N=46 | NCT05083260 | Sponsor: BioVie Inc. | "BioVie Inc...today announced data from an oral presentation made yesterday at the XXIX World Congress on Parkinson’s Disease and Related Disorders hosted by the International Association of Parkinsonism and Related Disorders (IAPRD) and held May 19-22, 2024 in Lisbon, Portugal....In patients younger than 70 years old (~50% of patients), the advantage for bezisterim-treated patients was -4.7 points. Furthermore, 30% of bezisterim-treated patients experienced improvement in their ability to move, having Part 3 scores prior to their first morning dose of carbidopa/levodopa that were equal to or better than Part 3 scores associated with their being in the “on” state after carbidopa/levodopa treatment at the start of the study..."

P2a data • CNS Disorders • Parkinson's Disease

A Review of Recent Advances in the Management of Alzheimer's Disease. (PubMed, Cureus) - "The conventional pharmacological agents revised comprise cholinesterase inhibitors, monoclonal antibodies, and other therapies, such as memantine, valproic acid, and rosiglitazone. The innovative reviewed pharmacological agents comprise the monoclonal antibodies: donanemab, gantenerumab, solanezumab, bapineuzumab, crenezumab, and semorinemab...Tau and amyloid-targeting treatments include methylthioninium moiety (MT), leuco-methylthioninium bis (LMTM), an oxidized form of MT, and tramiprosate, which inhibits the beta-amyloid (Aβ) monomer aggregation into toxic oligomers...The antidiabetic drugs include NE3107, an anti-inflammatory and insulin sensitizer, and the diabetes mainstream drug metformin. The anti-neuroinflammatory AD therapies include the use of sodium oligomannate (GV-971), infusions with intravenous immunoglobulin aiming to decrease plasma levels of the constituents of Aβ plaques, and masitinib, a tyrosine kinase inhibitor that impacts mast and microglia..."

Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • Diabetes • Inflammation • Insomnia • Metabolic Disorders • Sleep Disorder

BioVie Presents Data Showing Potential for Bezisterim (NE3107) to Reduce Inflammation and Restore Homeostasis in a Manner Correlated with Alzheimer’s Disease and Biomarker Endpoints (GlobeNewswire) - P3 | N=439 | NCT04669028 | Sponsor: BioVie Inc. | "BioVie Inc...today announced that an oral presentation and poster revealing additional data on how bezisterim potentially restores homeostasis was presented at the 12th Annual Alzheimer's & Parkinson's Drug Development Summit held in Boston, Massachusetts April 23-25....The data presented were based on further analysis of data generated from BioVie’s Phase 3 trial in Alzheimer’s disease (AD) that was unblinded at the end of 2023. The DNA methylation dataset assessed the extent of DNA methylation on roughly 965,000 individual sites where methyl groups can be attached to the patients’ DNA....Newly presented data show that patients treated with bezisterim experienced an age deceleration advantage over patients treated with placebo on four biological clocks, in addition to previously published advantage on the SkinBlood Clock3 (-3.68 years, p=0.017)."

P3 data • Alzheimer's Disease • CNS Disorders

BioVie to Present Data Showing How NE3107 Potentially Restores Homeostasis via Specific Genes Associated with Dementia, Metabolism, and Inflammation (GlobeNewswire) - "BioVie Inc...today announced that an oral presentation and poster presentation will be shared at the 12^th Annual Alzheimer's & Parkinson's Drug Development Summit to be held in Boston, Massachusetts April 23-25...Additionally, the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved 'bezisterim' as the non-proprietary (generic) name for NE3107, an orally active partial NF-κB inhibitor product candidate being studied in Parkinson’s Disease and Alzheimer’s Disease....The oral and poster presentations 12th Annual Alzheimer's & Parkinson's Drug Development Summit will provide additional details on how bezisterim appears to have an impact on DNA methylation on 5 different 'clocks' measuring biological age and that the extent of DNA methylation is correlated to a series of clinical measures."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

BioVie’s NE3107 Demonstrates Potential Improvements in Motor and Non-motor Symptoms for Parkinson’s Disease Patients and May Be Realigning Physiological Processes for Alzheimer’s Patients in Data to be Presented at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 (GlobeNewswire) - P3 | N=439 | NCT04669028 | Sponsor: BioVie Inc. | "BioVie Inc...today announced two upcoming presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 (AD/PD™ 2024) to be held March 5-9, 2024 in Lisbon, Portugal....Due to the exclusion of data from so many sites the trial missed statistical significance but showed promising directional data on cognitive and functional measures. NE3107-treated patients saw an advantage compared to placebo of -0.95 (68% slowing of decline) on CDR-SB, -0.94 (26%) on ADAS-COG-12, -0.43 (139%) on ADAS-CGIC, -0.03 (27%) on ADCOMS, +1.02 (40%) on MMSE, and +3.08 (47%) on ADCS-ADL. Significant improvements for NE3107-treated patients vs. placebo were observed for biological age deceleration (-3.87 years, p=0.012), fasting glucose levels (-8.5 mg/dL, p=0.036), cholesterol (-15 mg/dL, p=0.049)..."

P3 data • Alzheimer's Disease • CNS Disorders

BioVie’s NE3107 Demonstrates Potential Improvements in Motor and Non-motor Symptoms for Parkinson’s Disease Patients and May Be Realigning Physiological Processes for Alzheimer’s Patients in Data to be Presented at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 (GlobeNewswire) - P1/2 | N=46 | NCT05083260 | Sponsor: BioVie Inc. | "BioVie Inc...today announced two upcoming presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 (AD/PD™ 2024) to be held March 5-9, 2024 in Lisbon, Portugal....NE3107-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson’s Disease, whereas placebo patients experienced a worsening of +1.0 points (p=0.0159). Sleep/fatigue domain improvements correlated with motor score improvements (r=0.51; p=0.0259). More patients on NE3107 had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened."

P2a data • CNS Disorders • Parkinson's Disease

IMPROVEMENT OF NON-MOTOR SYMPTOMS WITH NE3107 ADJUNCTIVE TO CARBIDOPA/LEVODOPA IN PATIENTS WITH PARKINSON'S DISEASE: A PHASE 2A, PLACEBO-CONTROLLED STUDY (ADPD 2024) - "These data suggest that NE3107 may hold promise in ameliorating specific NMS of PD, particularly sleep/fatigue, urge to move legs and daytime drooling, in levodopa-treated patients with PD. This study supports the need for more comprehensive clinical exploration of NE3107's potential benefits in PD management."

Clinical • P2a data • CNS Disorders • Fatigue • Movement Disorders • Oncology • Parkinson's Disease • Restless Legs Syndrome • TNFA

CLINICAL OUTCOMES FROM A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NE3107 IN SUBJECTS WITH MILD TO MODERATE PROBABLE ALZHEIMER'S DISEASE (ADPD 2024) - P3 | "NE3107's potential anti-inflammatory and insulin sensitizing activity may offer clinical benefits in mild/moderate AD, consistent with the phase 2a findings."

Clinical • Clinical data • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Oncology • Psychiatry • Aβ42 • TNFA