Hepatology

Madrigal Pharmaceuticals Presents New Data from the Phase 3 MAESTRO-NASH Trial Demonstrating Broad Treatment Effects of Resmetirom on Noninvasive Measures of Liver Health

Retrieved on: 
Friday, November 10, 2023
THR, Hepatology, MRE, AASLD, CAP, Hepatitis, Therapy, Incremental cost-effectiveness ratio, ELF, Fibrosis, Priority review, Treatment, Cirrhosis, Lipid, Division, Non-alcoholic fatty liver disease, Fatty liver disease, Atherosclerosis, Abstract, Diabetes, Histology, Biopsy, NDA, Electronic health record, ALT, Artificial intelligence, University, Marie Cassidy, NASH, Intelligence, Research, Disease, LDL, FDA, Radiation Exposure Compensation Act, Medical imaging, Pharmaceutical industry, Boston, Patient, Risk, Gastroenterology

Resmetirom is a liver-directed thyroid hormone receptor (THR)-β agonist oral therapy that is designed to target key underlying causes of NASH.

Key Points: 
  • Resmetirom is a liver-directed thyroid hormone receptor (THR)-β agonist oral therapy that is designed to target key underlying causes of NASH.
  • It is the only investigational therapy for NASH that has achieved both fibrosis improvement and NASH resolution primary endpoints in a Phase 3 trial.
  • Resmetirom also reduced levels of LDL cholesterol and other lipids that are associated with heart disease.
  • Resmetirom is an investigational therapy and has not been approved by the FDA or any other regulatory authority.

Assembly Biosciences Presents New Data Highlighting Viral Hepatitis Portfolio at AASLD The Liver Meeting®

Retrieved on: 
Friday, November 10, 2023
Hepatology, VBR, Interferon, Viral, SAN, Hepatitis B virus, AASLD, Liver, Biotechnology, Patient, HBV, ISG, Assembly, HCV, Doctor of Philosophy, Poster, Pharmaceutical industry, Vaccine, Boston

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced new data from its virology portfolio featured in two presentations at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting®, taking place November 10-14, 2023, in Boston.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced new data from its virology portfolio featured in two presentations at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting®, taking place November 10-14, 2023, in Boston.
  • “Additionally, the Phase 2 data reported for vebicorvir in combination with Nrtl and Arbutus Biopharma’s AB-729 provide further insights that may inform future studies for the HBV and liver disease scientific community."
  • In addition, oral administration to preclinical species resulted in ISG induction in the liver and peripheral blood mononuclear cells (PBMCs).
  • Assembly Bio intends to make the presentations available on the “Events & Presentations” page in the “Investors” section of its website at www.assemblybio.com.

Intercept Announces New Findings from Long-term Extension of Landmark POISE Trial in PBC Showing Importance of Biomarkers Beyond ALP at AASLD The Liver Meeting® 2023

Retrieved on: 
Friday, November 10, 2023
PBC, Liver, ALP, GGT, Therapy, Poster, OCA, Hepatology, Intercept Pharmaceuticals, Survival

MORRISTOWN, N.J., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly-owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced new data from a sub-analysis of the landmark Phase 3 POISE trial evaluating the impact of obeticholic acid (OCA) on achievement of gamma-glutamyl transferase (GGT)

Key Points: 
  • This analysis suggests OCA’s potential to reduce GGT, in addition to the well-known effects on ALP levels, below the biochemical thresholds that are prognostic for worsening clinical outcomes.
  • These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston.
  • Elevated GGT in the setting of elevated ALP and other liver enzyme abnormalities is a marker for hepatobiliary disorder.
  • The goal of this sub-analysis was to evaluate the proportion of patients receiving OCA who achieved and sustained GGT

Aligos Therapeutics Presents Positive Data at the AASLD Liver Meeting® 2023 Demonstrating that Treatment with ALG-000184 (CAM-E) Results in Significant Multi-log Reductions in Hepatitis B Antigens (HBsAg, HBcrAg and HBeAg)

Retrieved on: 
Friday, November 10, 2023
Hepatology, Safety, DNA, SAN, Therapy, PEI, HBsAg, AASLD, Emory University, Liver, Week, Doctor of Philosophy, B, CccDNA, Liver cancer, Hepatitis B virus, CHB, Entecavir, MBA, University, Hepatitis, Hong Kong, Physician, Poster, ETV, RNA, Vaccine, Pharmaceutical industry, HBeAg, Boston, New York University, Gastroenterology, Jacob Aligo

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that emerging hepatitis B antigen lowering data for its capsid assembly modulator – empty (CAM-E) drug, ALG-000184, are available as a late breaking poster at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), being held in Boston, Massachusetts, November 10 – 14, 2023.

Key Points: 
  • The data will be presented by Dr. Man-Fung Yuen, Chair and Professor of Gastroenterology and Hepatology at the University of Hong Kong, in Poster Hall C on Monday November 13 from 1-2 pm ET.
  • “ALG-000184 appears to have best-in-class antiviral properties which are also unique compared to other drug classes being evaluated for the treatment of chronic hepatitis B (CHB).
  • If the trends observed to date continue, ALG-000184 has the potential to become a cornerstone therapy in the treatment of CHB.
  • The antiviral effects of ALG-000184 presented at AASLD indicate that this drug is achieving significant viral suppression, likely via inhibition of cccDNA synthesis.

Barinthus Bio Presents Interim Data from Phase 2b HBV003 Trial and Phase 2a AB-729-202 Trial in Collaboration with Arbutus Biopharma in Chronic HBV Patients at AASLD

Retrieved on: 
Thursday, November 9, 2023
Group 3, Hepatology, Safety, Immune system, Thyroiditis, RNA interference, AASLD, Risk, MVA, NUC, Patient, HBV, Clinical trial, Non-cirrhotic portal fibrosis, Liver, SOC, Autoimmune thyroiditis, CHB, Cancer, Nivolumab, Hepatitis, Group 2, Autoimmunity, Thyroid disease, Șaeș, Vaccine, Pharmaceutical industry, HBsAg

Alongside this, a late-breaking poster presentation with interim data from patients with chronic hepatitis B (CHB) from the Phase 2a AB-729-202 trial combining Arbutus Biopharma Corporation’s (NASDAQ: ABUS) RNAi therapeutic candidate, imdusiran (AB-729), with Barinthus Bio’s T cell stimulating immunotherapeutic candidate, VTP-300, and SoC NUC therapy.

Key Points: 
  • Alongside this, a late-breaking poster presentation with interim data from patients with chronic hepatitis B (CHB) from the Phase 2a AB-729-202 trial combining Arbutus Biopharma Corporation’s (NASDAQ: ABUS) RNAi therapeutic candidate, imdusiran (AB-729), with Barinthus Bio’s T cell stimulating immunotherapeutic candidate, VTP-300, and SoC NUC therapy.
  • Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.
  • Preliminary immunology data suggests HBV-specific T cell IFN-γ production was enhanced in patients receiving imdusiran plus VTP-300 compared to placebo.
  • Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma, commented, “Imdusiran consistently delivers compelling efficacy and safety data in multiple Phase 2a populations and combinations.

Arbutus Biopharma and Barinthus Bio Present Preliminary Data from Phase 2a Clinical Trial Combining Imdusiran with VTP-300 at AASLD - The Liver Meeting®

Retrieved on: 
Thursday, November 9, 2023
Hepatology, Virology, Immune system, University of Hong Kong, AASLD, Patient, HBV, Clinical trial, Division, Non-cirrhotic portal fibrosis, Liver, University, Cancer, Autoimmunity, CFBV, Vaccine, Pharmaceutical industry, HBsAg, Gastroenterology

WARMINSTER, Pa. and OXFORD, United Kingdom, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a cure for people with chronic hepatitis B virus (cHBV) infection, and Barinthus Biotherapeutics plc (Nasdaq: BRNS), formerly Vaccitech plc, a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer, today announced a late breaking poster presentation at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023. The poster contains preliminary data from the Phase 2a clinical trial (AB-729-202) combining Arbutus’ RNAi therapeutic, imdusiran (AB-729), with Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, and standard-of-care nucleos(t)ide analogue (NA) therapy.

Key Points: 
  • The poster contains preliminary data from the Phase 2a clinical trial (AB-729-202) combining Arbutus’ RNAi therapeutic, imdusiran (AB-729), with Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, and standard-of-care nucleos(t)ide analogue (NA) therapy.
  • Preliminary immunology data suggests HBV-specific T cell IFN-γ production is enhanced in patients receiving imdusiran plus VTP-300 compared to placebo.
  • The preliminary safety data from this trial demonstrate that imdusiran and VTP-300 were both safe and well-tolerated.
  • Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma, commented, “Imdusiran consistently delivers compelling efficacy and safety data in multiple Phase 2a populations and combinations.

Barinthus Bio Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, November 9, 2023
Hepatology, Research, Immune system, Depreciation, HBV, Hepatitis B, Arbutus, Vaccine, Liver, Infection, Healing, Cancer, Autoimmunity, Pharmaceutical industry, Vaccitech

OXFORD, United Kingdom, Nov. 09, 2023 (GLOBE NEWSWIRE) --  Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced its financial results for the third quarter of 2023 and provided an overview of its progress.

Key Points: 
  • OXFORD, United Kingdom, Nov. 09, 2023 (GLOBE NEWSWIRE) --  Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced its financial results for the third quarter of 2023 and provided an overview of its progress.
  • “The third quarter of 2023 was a period of solid progress for the Company.
  • We have since revealed the evolution of the company identity from Vaccitech to Barinthus Bio.
  • Cash position: As of September 30, 2023, the Company had cash and cash equivalents of $160.3 million, compared to $173.0 million as of June 30, 2023.

CN Bio PhysioMimix Organ-on-a-Chip Data Supports Inipharm’s INI-822 for Metabolic Liver Disease Treatment Now in Clinical Testing

Retrieved on: 
Monday, December 4, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Molecule, OOC, Research, DSM-IV codes, Non-alcoholic fatty liver disease, Prevalence, MPS, Hepatology, Patient, Therapy, Drug discovery, NIAB, HSD17B13, NASH, Pharmaceutical industry

The use of in vitro OOC for early evidence of efficacy for INI-822 demonstrates the transformative potential of these models to provide human-relevant data within preclinical programmes.

Key Points: 
  • The use of in vitro OOC for early evidence of efficacy for INI-822 demonstrates the transformative potential of these models to provide human-relevant data within preclinical programmes.
  • Loss-of-function variants of this gene are known to be associated with reduced incidence risk and severity of multiple liver diseases.
  • As part of the recent regulatory submission, CN Bio’s Contract Research Services team utilised the Company’s PhysioMimix OOC Systems and NASH ‘in-a-box' (NIAB) kit to generate critical data to determine compound efficacy.
  • For more information, visit: https://cn-bio.com/
    Inipharm Initiates Dosing in Phase 1 Study of Its Small Molecule Inhibitor of HSD17B13: https://www.businesswire.com/news/home/20231130655005/en/
    View source version on businesswire.com: https://www.businesswire.com/news/home/20231204544807/en/

Inipharm Initiates Dosing in Phase 1 Study of Its Small Molecule Inhibitor of HSD17B13

Retrieved on: 
Thursday, November 30, 2023
Biotechnology, Health, Science, Pharmaceutical, Research, Conditional sentence, Pharmacokinetics, Liver injury, Biomarker, Fatty liver disease, Safety, Patient, HSD17B13, Hepatology, Part, NASH, Inflammation, RNA, Fibrosis, Pharmaceutical industry, Vaccine

Inipharm , a biopharmaceutical company focused on discovering and developing therapies for severe liver diseases, today announced that it has begun dosing in a Phase 1 study of INI-822, its orally-delivered small molecule inhibitor of HSD17B13.

Key Points: 
  • Inipharm , a biopharmaceutical company focused on discovering and developing therapies for severe liver diseases, today announced that it has begun dosing in a Phase 1 study of INI-822, its orally-delivered small molecule inhibitor of HSD17B13.
  • INI-822, believed to be the first small molecule inhibitor of HSD17B13 to advance to clinical development, is under development for fibrotic liver diseases, including non-alcoholic steatohepatitis (NASH).
  • “I want to applaud the Inipharm team who has worked tirelessly to develop a small molecule that can inhibit HSD17B13,” said Brian Farmer, co-founder and chief executive officer of Inipharm.
  • “This target presents significant challenges with respect to the development of a small molecule inhibitor.

ENDRA Life Sciences Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
Radiology, Health, Clinical Trials, Medical Devices, Proton, Sale, Magnetic resonance imaging, Hepatology, NAFLD, NDRA, Research, De novo, Food, Endocrinology, International, Magnetic resonance, PIN, Agency, FDA, Non-alcoholic fatty liver disease, Marketing, Liver, De novo synthesis, ATM, NPV, Fatty liver disease, Medical imaging, Video game

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • Highlights from the third quarter of 2023 and recent weeks include:
    Shared positive TAEUS clinical data at the Steatotic Liver Disease Summit™ 2023 hosted by the European Association for the Study of the Liver.
  • TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.87.
  • During the third quarter of 2023 and recent weeks, ENDRA was issued six additional patents, including two in the U.S., two in Europe and two in China.