NAFLD

Inventiva announces positive topline results from the investigator-initiated Phase II clinical trial evaluating lanifibranor in patients with T2D and NAFLD

Retrieved on: 
Tuesday, June 13, 2023
Tissue, Steatosis, Mucopolysaccharidosis, Insulin, Obesity, CAP, University, Table, NASH, Metabolism, University of Florida, Clinical trial, Diabetes, Department of Medicine – University of Pamplona, T2DM, MPS, Trial of the century, Plasma, Fibrosis, Euronext Paris, Prediabetes, Publication, Publishing, Patient, Data, Division, Microwave spectroscopy, Fatty liver disease, Liver, NAFLD, Principal, Phase, T2D, Fasting, Safety, Pharmaceutical industry, Medical imaging, Medical device, Medicine, F.A.C.E, Endocrinology

A significantly higher proportion of patients achieved a greater than 30% liver triglyceride reduction as well as NAFLD resolution with lanifibranor compared to placebo.

Key Points: 
  • A significantly higher proportion of patients achieved a greater than 30% liver triglyceride reduction as well as NAFLD resolution with lanifibranor compared to placebo.
  • fasting plasma insulin, fasting hepatic glucose production, hepatic insulin resistance index, insulin-stimulated muscle glucose disposal), which translated into better glycemic control (i.e.
  • The study met multiple secondary metabolic endpoints confirming the cardiometabolic benefit of lanifibranor in patients with NAFLD, and ability to improve adipose tissue function (i.e.
  • The Phase II clinical trial randomized 38 patients into two arms, with patients receiving placebo or treatment with lanifibranor at 800mg/day for 24 weeks.

Merck to Present Data for Efinopegdutide (MK-6024), an Investigational GLP-1/Glucagon Receptor Co-agonist, in Patients with Nonalcoholic Fatty Liver Disease (NAFLD) at EASL 2023

Retrieved on: 
Monday, June 12, 2023
Biotechnology, FDA, Diabetes, Health, General Health, Pharmaceutical, Oncology, Research, Science, Veterinary, Clinical Trials, MSD, EASL, NASH, MRK, Inflammation, Merck & Co., Congress, Patient, CEST, Fatty liver disease, NAFLD, European Association for the Study of the Liver, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fast track (FDA), NYSE, Food, Safety, Pharmaceutical industry, Liver, Merck

Data to be shared include results from the Phase 2a clinical trial evaluating efinopegdutide in adult patients with nonalcoholic fatty liver disease (NAFLD).

Key Points: 
  • Data to be shared include results from the Phase 2a clinical trial evaluating efinopegdutide in adult patients with nonalcoholic fatty liver disease (NAFLD).
  • Separately, efinopegdutide was recently granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) as a potential treatment for patients with nonalcoholic steatohepatitis (NASH), a more severe form of NAFLD that includes inflammation and damage to the liver.
  • Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need.
  • “We are looking forward to sharing detailed findings from the Phase 2a study of efinopegdutide with the scientific community at the EASL Congress,” said Sam Engel, associate vice president, global clinical development, Merck Research Laboratories.

Growth in Patient and Medical Community Engagement in NASH Community Persists Despite Recent Regulatory Disappointment

Retrieved on: 
Thursday, June 8, 2023
Permanent Damage, Fatty liver disease, Obesity, International, Habit, NASH, Life, GLI, Liver disease, Type 2 diabetes, Scar, Human, HTA, Research, Risk, Social media, Movement, Patient, JD, Overweight, Liver, NAFLD, Society, Cirrhosis, Disease, Dietary supplement, Pharmaceutical industry, Nursing

An estimated 25% of the global population , or about 2 billion people, are affected by NAFLD.

Key Points: 
  • An estimated 25% of the global population , or about 2 billion people, are affected by NAFLD.
  • “We have been heartened through collaboration with the broader patient advocacy community on health technology assessment (HTA) and regulatory processes.
  • Despite established risk factors, too often patients in high-risk groups are still not triaged, not screened, and not connected to the care they require.
  • We urge health system leaders to step up and examine the NASH patient pathway, identify where patients are lost, and bolster those processes.

89bio Announces Late-Breaker Oral Presentation of Data from the Phase 2 ENLIVEN Study of Pegozafermin at EASL International Liver Congress 2023

Retrieved on: 
Wednesday, June 7, 2023
EASL, University, NASH, University of California, San Diego, Congress, Patient, SAN, Fatty liver disease, NAFLD, European Association for the Study of the Liver, Pharmaceutical industry, Liver

SAN FRANCISCO, June 07, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that pegozafermin data in nonalcoholic steatohepatitis (NASH) will be featured in a late-breaker oral presentation during the European Association for the Study of the Liver (EASL) Congress 2023 to be held June 21-24, 2023 in Vienna, Austria.

Key Points: 
  • SAN FRANCISCO, June 07, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that pegozafermin data in nonalcoholic steatohepatitis (NASH) will be featured in a late-breaker oral presentation during the European Association for the Study of the Liver (EASL) Congress 2023 to be held June 21-24, 2023 in Vienna, Austria.
  • The presentation was selected for inclusion in the Best of EASL Congress summary slide deck that highlights the most noteworthy contributions to the scientific program at EASL.
  • Details for the late-breaker oral presentation are as follows:
    Abstract Title: Pegozafermin for the treatment of non-alcoholic steatohepatitis patients with F2/F3 fibrosis: a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial (ENLIVEN)
    Presenting Author: Rohit Loomba, M.D., MHSc, Director, NAFLD Research Center, University of California San Diego, and lead investigator of ENLIVEN
    89bio will also present data from a preclinical study.
  • Presentation details are as follows:

Inventiva announces five scientific presentations at the EASL International Liver Congress™ 2023

Retrieved on: 
Wednesday, June 7, 2023
Steatosis, Abstract, Insulin resistance, EASL, Histology, European Association for the Study of the Liver, NASH, CAP, PPAR, Diabetes, Jugular venous pressure, Liver disease, Biomarker, Inflammation, Fibrosis, Euronext Paris, GW501516, Metabolism, Patient, Splanchnic, Fatty liver disease, ALT, NAFLD, European Association for the Study of Diabetes, Adiponectin, Isotope, Medical imaging, Pharmaceutical industry, Silviculture, Liver, Rosiglitazone, Fenofibrate

the reduction of the increased portal pressure and improvement of steatosis in a rat model of early NAFLD following a 4-week lanifibranor treatment.

Key Points: 
  • the reduction of the increased portal pressure and improvement of steatosis in a rat model of early NAFLD following a 4-week lanifibranor treatment.
  • the greater reduction of the increased portal pressure associated with early NAFLD following lanifibranor treatment compared to the PPAR agonists α, δ  or γ individually.
  • The hepatic  steatosis was measured by histological grading and by imaging using Controlled Attenuation Parameter (“CAPTM”) Fibroscan®.
  • The fourth abstract evaluates the effect of lanifibranor on portal pressure, endothelial dysfunction and liver histology in a rat model of early NAFLD.

GENFIT Announces New Data at the European Association for the Study of the Liver (EASL) Congress 2023

Retrieved on: 
Wednesday, June 7, 2023
Abstract, EASL, Diagnosis, NASH, Hepatology, NIT, NTZ, Congress, Patient, NAFLD, Medical device, ACLF, Euronext

Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); June 7, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced that it will present new data at the EASL Congress which will take place on June 21-24, 2023 in Vienna, Austria.

Key Points: 
  • Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); June 7, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced that it will present new data at the EASL Congress which will take place on June 21-24, 2023 in Vienna, Austria.
  • GENFIT has had three abstracts accepted for poster sessions.
  • Session: June 24, 2023 between 9.00am – 5.00pm at NAFLD: Diagnostics and non-invasive assessment (selected for inclusion in the Best of EASL Congress summary slide deck).
  • Session: June 24, 2023 between 9.00am – 5.00pm at NAFLD: Diagnostics and non-invasive assessment
    GENFIT will host an investigator meeting on June 22, 2023 in relation to the international UNVEIL-IT™ Phase 2 study which is currently being conducted, evaluating VS-01 in ACLF.

Madrigal Pharmaceuticals Supports International NASH Day on June 8

Retrieved on: 
Tuesday, June 6, 2023
Exercise, CME, Fatty liver disease, Knowledge, Disease, Endocrinology, Research and development, International, Partnership, Therapy, NASH, Education, Health, GLI, Hepatocellular carcinoma, Gastroenterology, Research, Continuing medical education, Organization, Liver disease, Patient, Physician, Risk, NAFLD, Cirrhosis, Social media, Caregiver, Pharmaceutical industry, Nursing, Dietary supplement, Madrigal, Medscape

CONSHOHOCKEN, Pa., June 06, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced its support for the sixth International NASH Day , taking place on June 8, 2023.

Key Points: 
  • CONSHOHOCKEN, Pa., June 06, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced its support for the sixth International NASH Day , taking place on June 8, 2023.
  • Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “Madrigal is proud to support International NASH Day, and we would like to extend our thanks to the patient advocates who are working to improve awareness and understanding of the disease.
  • The Madrigal team looks forward to participating in International NASH Day and joining patients and providers across the globe to ‘Step Up for NASH.’”
    International NASH Day is the premier, international education campaign that occurs annually to raise visibility and urgency around the impact of nonalcoholic fatty liver disease (NAFLD) and its more advanced form, NASH, on communities across the globe.
  • Taking on Fatty Liver and NASH complements the NASH Explored disease education campaign for healthcare providers, and reflects Madrigal’s efforts to support better conversations between patients and physicians about at-risk NASH.

Shattering the Silence: Unveiling the Quiet Epidemic of NAFLD and NASH on International NASH Day

Retrieved on: 
Wednesday, June 7, 2023
Exercise, Liver, Fatty liver disease, Obesity, International, NASH, Diabetes, Education, Health, Liver disease, Public, Risk, Inflammation, Type, Liver cancer, HIV disease progression rates, Hepatology, Metabolic syndrome, Non-alcoholic fatty liver disease, NAFLD, Liver failure, Cirrhosis, Disease, Nursing, Dietary supplement

This special day is dedicated to raising awareness about non-alcoholic fatty liver disease (NAFLD) and its severe form, non-alcoholic steatohepatitis (NASH).

Key Points: 
  • This special day is dedicated to raising awareness about non-alcoholic fatty liver disease (NAFLD) and its severe form, non-alcoholic steatohepatitis (NASH).
  • NAFLD and NASH are emerging public health concerns which currently affect over 115 million people worldwide1.
  • In Canada alone, a recent Canadian study projected a 20% increase in the frequency of NAFLD by 20302.
  • NAFLD and NASH occur when excess fat accumulates in the liver, leading to inflammation and possible liver damage.

The Rising NAFLD/NASH Epidemic Coupled with High Patient Need Offers Opportunities for Pharmaceutical Manufacturers to Capitalize Across Various Disease Stages, According to Spherix Global Insights

Retrieved on: 
Tuesday, May 23, 2023
Lipotoxicity, Insulin resistance, Madrigal, FXR, Fibrosis, Obesity, NASH, Novo Nordisk, Diabetes, Liver disease, Obeticholic acid, Cardiovascular disease, Weight loss, Intercept Pharmaceuticals, NDA, History, Type 2 diabetes, Gastroenterology, GLP1, SCD1, FGF21, Inflammation, Hypertension, Hyperlipidemia, Incidence, Metabolism, Patient, Metabolic syndrome, Physician, OCA, Cirrhosis, ICER, NAFLD, Bariatric surgery, FDA, Therapy, Hepatitis, Pharmaceutical industry, Nursing

EXTON, Pa., May 22, 2023 /PRNewswire/ -- The non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH) epidemic is roughly 2.5 times greater than diabetes in the U.S. Despite the significant size and unmet need of the potential market, pharmaceutical companies have yet to capitalize on the opportunity.  

Key Points: 
  • Despite the significant size and unmet need of the potential market, pharmaceutical companies have yet to capitalize on the opportunity.
  • Both resmetirom and OCA are being evaluated in NASH patients with confirmed liver fibrosis.
  • Insights from Spherix's Market Dynamix™ NAFLD/NASH service highlight reducing liver fibrosis is currently the highest priority for gastroenterologists.
  • The road to achieving life changing treatment for NAFLD/NASH is long and fraught with difficulty, but for the companies committed to helping these patients, opportunities abound.

Boston Pharmaceuticals Announces Acceptance of Late-Breaking Abstract Highlighting New Phase 2 Clinical Data from BOS-580 NASH Program at EASL 2023

Retrieved on: 
Thursday, May 18, 2023
Biotechnology, Pharmaceutical, Health, University, Liver disease, NASH, Liver injury, FGF21, Biomarker, San Diego, Medication, Fibrosis, Patient, Division, Gastroenterology, Fatty liver disease, NAFLD, European Association for the Study of the Liver, FC, Pharmaceutical industry, Medicine

Boston Pharmaceuticals today announced that new results from its ongoing Phase 2a study evaluating BOS-580 for the treatment of non-alcoholic steatohepatitis (NASH) were accepted as a late-breaking poster presentation at the European Association for the Study of the Liver International Liver Congress, June 21-24 in Vienna, Austria.

Key Points: 
  • Boston Pharmaceuticals today announced that new results from its ongoing Phase 2a study evaluating BOS-580 for the treatment of non-alcoholic steatohepatitis (NASH) were accepted as a late-breaking poster presentation at the European Association for the Study of the Liver International Liver Congress, June 21-24 in Vienna, Austria.
  • BOS-580 is a genetically engineered variant of human fibroblast growth factor 21 (FGF21), administered via a monthly subcutaneous injection, that is designed to reduce liver fat, liver injury, and fibrosis in patients with NASH and improve other metabolic biomarkers.
  • Additional details of the late-breaker presentation are as follows:
    Title: Twelve-week treatment with BOS-580, a novel, long-acting Fc-FGF-21 fusion protein, leads to a reduction in liver steatosis, liver injury, and fibrosis in patients with phenotypic NASH: A randomized, blinded, placebo-controlled Phase 2A trial
    Presenter: Dr. Rohit Loomba, M.D., MHSc, Director at NAFLD Research Center, Director of Hepatology, Professor of Medicine and Vice Chief of the Division of Gastroenterology at University of California at San Diego