terlipressin diacetate (BIV201) / 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

Reply: Continuous Infusion terlipressin for refractory ascites-key considerations for future trials. (PubMed, Liver Transpl) - No abstract available

Journal

Safety and efficacy of continuous infusion terlipressin (BIV201): A phase 2 trial in patients with decompensated cirrhosis and refractory ascites. (PubMed, Liver Transpl) - "Despite the high rate of hyponatremia in the BIV201+SOC group (4/10 patients), the safety profile suggested that continuous BIV201 infusion was well tolerated. These findings support further development of BIV201 in confirmatory trials."

Journal • P2 data • Cardiovascular • Fibrosis • Heart Failure • Hepatology • Immunology • Nephrology • Renal Disease

Potential augmentation of terlipressin antidiuretic effects by gabapentinoids. (PubMed, J Hepatol) - No abstract available

Journal

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2 | N=15 | Terminated | Sponsor: BioVie Inc. | N=30 ➔ 15 | Trial completion date: Nov 2023 ➔ May 2023 | Active, not recruiting ➔ Terminated; For reasons unrelated to safety or efficacy

Enrollment change • Trial completion date • Trial termination • Fibrosis • Hepatology • Immunology

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: BioVie Inc. | Trial completion date: Apr 2023 ➔ Nov 2023 | Trial primary completion date: Mar 2023 ➔ Aug 2023

Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: BioVie Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Hepatology • Immunology

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: BioVie Inc. | Trial completion date: Aug 2022 ➔ Apr 2023 | Trial primary completion date: Jul 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: BioVie Inc. | Trial completion date: Mar 2022 ➔ Aug 2022 | Trial primary completion date: Feb 2022 ➔ Jul 2022

Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: BioVie Inc.; Trial completion date: Dec 2021 ➔ Mar 2022; Trial primary completion date: Nov 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: BioVie Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Fibrosis • Hepatology • Immunology

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: BioVie Inc.; Trial completion date: Jul 2021 ➔ Oct 2021; Trial primary completion date: Apr 2021 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology

A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites (clinicaltrials.gov) - P2; N=24; Not yet recruiting; Sponsor: BioVie Inc.; Phase classification: P2b ➔ P2; N=132 ➔ 24; Initiation date: Dec 2019 ➔ Jul 2020; Trial primary completion date: Jul 2021 ➔ Apr 2021

Clinical • Enrollment change • Phase classification • Trial initiation date • Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology