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

ADdRESs-LC: NE3107 in Adults With Neurological Symptoms of Long COVID (clinicaltrials.gov) - P2 | N=203 | Completed | Sponsor: BioVie Inc. | Active, not recruiting ➔ Completed

Trial completion • Novel Coronavirus Disease

BioVie advances Parkinson’s Phase 3 development program with FDA engagement (Yahoo Finance) - "The company is working with Parkinson's disease clinical development experts to finalize the design of a Phase 3 trial...The company expects the proposed enrichment strategy, which would target patients with higher levels of inflammation, could support a Phase 3 trial of approximately 175 patients. BioVie expects to discuss the proposed trial design with the FDA later this fall and anticipates receiving formal written feedback before the end of 2026."

Clinical protocol • FDA event • New P3 trial • Parkinson's Disease

SUNRISE-PD: A Study of NE3107 in Early Parkinson's (clinicaltrials.gov) - P2 | N=57 | Completed | Sponsor: BioVie Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

BioVie Announces Topline Results of Phase 2 SUNRISE-PD Trial of Bezisterim in Early Parkinson’s Disease (GlobeNewswire) - "Under the statistical analysis plan submitted to the U.S. Food and Drug Administration (FDA), the study’s primary pharmacodynamic assessment focused on changes in a predefined panel of blood-based inflammatory markers of disease....The trial successfully met prespecified endpoints and achieved its objectives....The majority of patients treated with bezisterim showed improvement on EPNIC-15,2 a composite endpoint encompassing 15 clinically relevant motor and non-motor measures of PD. In contrast, patients receiving placebo showed a change in the opposite direction (bezisterim = -0.04, placebo = +0.18, Cohen’s d = -0.94, p=0.0006). EPNIC-15 aligns clinical outcome measurements from UPDRS Parts I (non-motor symptoms), II (activities of daily living), and III (motor symptoms), as well as PDSS-2 (sleep) with bezisterim’s proposed mechanism of action, providing a sensitive tool to evaluate anti-inflammatory treatment effects in early PD."

P2 data • Parkinson's Disease

ADDRESS-LC: study protocol for a phase 2, triple-blind, randomised, placebo-controlled trial to evaluate the efficacy and safety of bezisterim (NE3107) in adults with long COVID. (PubMed, BMJ Open) - P2 | "The study will disseminate results through academic publication and conference presentations. NCT06847191."

Clinical protocol • Journal • P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Fatigue • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • Sleep Disorder

ADdRESs-LC: NE3107 in Adults With Neurological Symptoms of Long COVID (clinicaltrials.gov) - P2 | N=203 | Active, not recruiting | Sponsor: BioVie Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Novel Coronavirus Disease

BioVie Announces Completion of Phase 2 SUNRISE-PD Trial in Early-Stage Parkinson’s Disease (GlobeNewswire) - "Last Patient Evaluation Visit Completed with Topline Data Release Targeted Q3-2026....'This trial was designed to assess bezisterim’s magnitude of therapeutic impact on a series of motor and non-motor endpoints so that we can finalize the design for the Phase 3 registrational trials.'"

P2 data • Trial completion • Parkinson's Disease

SUNRISE-PD: A Study of NE3107 in Early Parkinson's (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: BioVie Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ May 2026 | Trial primary completion date: Dec 2025 ➔ May 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

BioVie to host KOL event highlighting Bezisterim's potential in Parkinson's Disease (Proactiveinvestors) - "The event will include an update on BioVie's Phase 2 trial evaluating bezisterim, an oral small molecule that has shown potential to reduce insulin resistance and inhibit inflammation-driven pathways linked to Parkinson's progression."

Trial status • Parkinson's Disease

A Study of NE3107 (Bezisterim) in Early Parkinson’s Disease (SUNRISE-PD): Baseline Demographics and Characteristics (AAN 2026) - P2 | "Conclusions A critical step in developing new treatments for PD is analyzing trends in demographics and disease characteristics among various patient populations, which is the aim of this descriptive study on the currently enrolled SUNRISE-PD patients. Upon study completion, SUNRISE-PD is expected to provide important data on the benefits of bezisterim in patients with early PD, laying the foundation for a study of potential disease-modifying activity."

CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder • TNFA

BioVie Announces Abstract Accepted for Presentation at the 2026 American Academy of Neurology Annual Meeting (Yahoo Finance) - "The abstract...summarizes the initial data on patients enrolled in the SUNRISE-PD study, and will be presented as a poster during the Movement Disorders Session on Parkinson's Disease Emerging Therapeutics, on Monday, April 20, from 5:00 PM–6:00 PM CT....Topline results from the SUNRISE-PD study are expected in mid‑2026."

P2 data • Parkinson's Disease

BioVie targets neuroinflammation and insulin resistance in Parkinson’s treatment approach (Yahoo Finance) - "With enrollment now complete, BioVie is targeting a topline data readout before the end of June, marking an important near-term catalyst for the program."

P2b data • Parkinson's Disease

DEMOGRAPHICS AND BASELINE CHARACTERISTICS OF PARTICIPANTS IN A STUDY OF BEZISTERIM (NE3107) IN EARLY PARKINSON'S DISEASE (SUNRISE-PD) (ADPD 2026) - P2 | "Baseline demographics and disease characteristics of PD patient populations are essential for interpreting later results, a critical step in developing new treatments for PD. SUNRISE-PD is expected to provide important data on the benefits of bezisterim in patients with early PD and lay the foundation for a study of potential disease-modifying activity."

CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder • TNFA

BioVie Announces Abstract Accepted for Presentation at AD/PD 2026 (The Manila Times) - "The abstract....summarizes the initial data on patients enrolled in the SUNRISE-PD study, and will be presented as a poster. Topline results from the SUNRISE-PD study are expected in mid‑2026....The AD/PD Alzheimer’s Disease and Parkinson’s Disease Conference will present all the latest breakthroughs in treatment, translational R&D, early diagnosis, drug development, and clinical trials in Alzheimer’s, Parkinson’s, and other related neurological disorders."

Clinical • P2b data • Alzheimer's Disease • Parkinson's Disease

Join Biovie’s Exclusive Live Investor Webinar and Q&A Session on March 4 (GlobeNewswire) - "The exclusive event, hosted by RedChip Companies, will feature Cuong Do, President and CEO of BioVie, who will discuss BioVie’s investigational drug candidate bezisterim (NE3107), a 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 orphan drug candidate for patients suffering from cirrhosis and ascites, who are subject to life-threatening complications with no FDA-approved therapies."

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

BioVie Inc...announced the acceptance of two abstracts from studies on its lead candidate bezisterim (NE3107), in the treatment of Alzheimer’s Disease and Long COVID at the 2026 American College of Psychiatrists (ACP) annual meeting, to be held February 18-22, in Bonita Springs, FL. (GlobeNewswire)

Clinical data • Alzheimer's Disease • Novel Coronavirus Disease

BioVie could offer first new Parkinson’s therapy in decades (Proactiveinvestors) - "Topline data from SUNRISE-PD are expected in April or May 2026, placing the company firmly in a catalyst window that many biotech investors look for."

P2b data • Parkinson's Disease

ADdRESs-LC: NE3107 in Adults With Neurological Symptoms of Long COVID (clinicaltrials.gov) - P2 | N=208 | Recruiting | Sponsor: BioVie Inc. | Trial completion date: Jan 2026 ➔ Aug 2026 | Trial primary completion date: Nov 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Novel Coronavirus Disease

BioVie Inc...announced that it has completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in individuals with early-stage Parkinson’s disease (PD) who have not been treated with carbidopa/levodopa. (BioVie Press Release) - "Now that participant enrollment is complete, the Company anticipates analyzing and reporting top-line results first half of 2026."

Enrollment closed • P2b data • Parkinson's Disease

BioVie advances Parkinson’s...programs ahead of 2026 (Proactiveinvestors) - "...BioVie has launched a new clinical trial enrolling 60 patients with earlier-stage Parkinson’s disease to evaluate Bezisterim as a standalone therapy. The goal of the study is to assess the drug’s potential disease-modifying effects when administered earlier in the disease course. Topline data from this trial are expected in April or May of 2026."

P2 data • Trial status • Parkinson's Disease

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