Steatohepatitis

Gyre Therapeutics Presents Poster at the American Association for the Study of Liver Diseases (AASLD) Annual Liver Meeting

Retrieved on: 
Monday, November 13, 2023

SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (NASDAQ: GYRE), a clinical-stage biotechnology company developing anti-fibrotic therapeutics for a variety of chronic liver diseases, today announced the presentation of a poster at the American Association for the Study of Liver Diseases’ (AASLD) Annual Liver Meeting, November 10-14, 2023, in Boston, Massachusetts.

Key Points: 
  • SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (NASDAQ: GYRE), a clinical-stage biotechnology company developing anti-fibrotic therapeutics for a variety of chronic liver diseases, today announced the presentation of a poster at the American Association for the Study of Liver Diseases’ (AASLD) Annual Liver Meeting, November 10-14, 2023, in Boston, Massachusetts.
  • Gyre’s lead asset, Hydronidone, is currently being investigated for the treatment of Metabolic Dysfunction Associated Steatohepatitis (MASH)-associated liver fibrosis in the United States.
  • Gyre’s poster presented the potential antifibrotic effects of Hydronidone and its expected mode of action in mouse hepatic fibrosis models.
  • The obtained mechanistic data support the potential of Hydronidone for the treatment of liver fibrosis associated with a spectrum of chronic liver diseases.

Galectin Therapeutics Reports the Positive Outcome of the Fourth Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Portal Hypertension Caused by Non-Alcoholic SteatoHepatitis Live

Retrieved on: 
Tuesday, October 3, 2023

NAVIGATE is the first study of its kind and is a global effort that randomized 357 patients in 14 countries on five continents.

Key Points: 
  • NAVIGATE is the first study of its kind and is a global effort that randomized 357 patients in 14 countries on five continents.
  • Interim topline data from the Phase 2b portion of NAVIGATE is expected in the fourth quarter of 2024.
  • Patients enrolled in the study have liver cirrhosis caused by NASH and, because of the advancing cirrhotic process, have already developed portal hypertension but have not yet developed esophageal varices as a complication of portal hypertension.
  • The objective of this fourth independent DSMB was to further review the emerging tolerance and safety profiles of belapectin.

Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis

Retrieved on: 
Wednesday, September 13, 2023

The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
  • Madrigal is seeking approval of resmetirom for the treatment of patients with NASH and liver fibrosis under the FDA’s accelerated approval pathway.
  • A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review).

Terns Achieves Primary Endpoint and All Secondary Endpoints in Phase 2a DUET Trial of THR-β Agonist TERN-501 in NASH

Retrieved on: 
Tuesday, August 8, 2023

FOSTER CITY, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity, today reported positive top-line results from the Phase 2a DUET clinical trial of TERN-501, an orally-administered thyroid hormone receptor-beta (THR-β) agonist, administered as a monotherapy or in combination with TERN-101, a liver-distributed farnesoid X receptor (FXR) agonist, for the treatment of NASH.

Key Points: 
  • TERN-501 monotherapy demonstrated improvement or trends toward improvement in plasma lipid parameters, such as LDL-C, HDL-C, triglycerides, and apolipoprotein B (ApoB).
  • TERN-501 was generally well tolerated, with adverse events (AEs) being generally mild and evenly distributed across all arms, including placebo.
  • TERN-101 safety and tolerability findings were generally consistent with the Phase 2a LIFT trial.
  • A replay of the call will also be available on the Events page of the Investor Relations section of the Terns website for 30 days.

Akero Therapeutics Presents Analyses of Phase 2b HARMONY Study at the 2023 International Liver Congress Reinforcing and Characterizing EFX-Related Improvements in Liver Histopathology

Retrieved on: 
Friday, June 23, 2023

The posters are being presented at the 2023 International Liver Congress today and tomorrow and will be available on Akero’s website .

Key Points: 
  • The posters are being presented at the 2023 International Liver Congress today and tomorrow and will be available on Akero’s website .
  • Results of non-invasive tests performed as part of the HARMONY study were correlated with EFX-related changes in liver histopathology after 24 weeks of treatment.
  • The poster shows that EFX-associated changes in non-invasive tests were associated with improvements in NASH histopathology.
  • The post-hoc semi-quantitative analysis characterized changes in liver histopathology through the evaluation of steatosis-activity-fibrosis (SAF) and SAF-Activity (SAF-A) scores.

Arrowhead Pharmaceuticals Gains Full Rights to NASH Candidate ARO-PNPLA3 with Promising Phase 1 Results

Retrieved on: 
Wednesday, February 15, 2023

PNPLA3 is a unique NASH drug target as the I148M disease associated variant increases the risk of NAFLD, NASH, and hepatocellular carcinoma by 4 to 12-fold for homozygotes.

Key Points: 
  • PNPLA3 is a unique NASH drug target as the I148M disease associated variant increases the risk of NAFLD, NASH, and hepatocellular carcinoma by 4 to 12-fold for homozygotes.
  • We understand that Janssen is undergoing a strategic R&D portfolio review and subsequently advised us of their decision to return full rights to this promising NASH candidate back to Arrowhead,” said Christopher Anzalone, Ph.D., Arrowhead’s president and CEO.
  • Although there are many investigational drugs in clinical study, there are no drugs specifically approved for the treatment of NASH.
  • Up to 30% of those with NAFLD will go on to develop NASH which can progress to liver cirrhosis.

Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis

Retrieved on: 
Friday, January 6, 2023

The new MAESTRO-NASH data are being presented at the NASH-TAG Conference, taking place from January 5-7, 2023 in Park City, Utah.

Key Points: 
  • The new MAESTRO-NASH data are being presented at the NASH-TAG Conference, taking place from January 5-7, 2023 in Park City, Utah.
  • An MRI-PDFF conducted during screening confirmed that patients had NAFLD prior to obtaining a liver biopsy.
  • Each pathologist's scores showed a similar statistically significant magnitude of response at both doses for both liver biopsy endpoints.
  • The consensus read by the two central pathologists reinforced the positive results observed in the primary analysis (Tables 1-2).

Sagimet Biosciences Announces Positive Interim Phase 2b Clinical Trial Data with Denifanstat (TVB-2640), a First-in-Class Fatty Acid Synthase Inhibitor, in Moderate-to-Severe Non-alcoholic Steatohepatitis (NASH) Patients

Retrieved on: 
Thursday, November 3, 2022

We are pleased to report such robust and durable results across a range of biomarkers in the interim analysis of our FASCINATE-2 study, said David Happel, chief executive officer, Sagimet.

Key Points: 
  • We are pleased to report such robust and durable results across a range of biomarkers in the interim analysis of our FASCINATE-2 study, said David Happel, chief executive officer, Sagimet.
  • These data underscore the potential of denifanstat to treat a broad NASH patient population and reinforce our commitment to addressing this emerging health epidemic.
  • We look forward to the complete trial readout with biopsy data in the fourth quarter of 2023, and subsequent launch of a pivotal Phase 3 trial.
  • Sagimet compounds are designed to inhibit fatty acid synthase, an enzyme involved in the production of fatty acids normally used for energy storage.

Rimidi and Boston Medical Center Release Metrics from Ongoing Remote Monitoring Program for Postpartum Hypertension

Retrieved on: 
Tuesday, August 30, 2022

ATLANTA and BOSTON, Aug. 30, 2022  /PRNewswire-PRWeb/ -- Rimidi, a leading clinical management platform designed to optimize clinical workflows, enhance patient experiences and achieve quality objectives, and Boston Medical Center, a private, not-for-profit academic medical center in New England, today released metrics from an ongoing remote patient monitoring program for new moms at high-risk of postpartum hypertension.

Key Points: 
  • ATLANTA and BOSTON, Aug. 30, 2022 /PRNewswire-PRWeb/ -- Rimidi , a leading clinical management platform designed to optimize clinical workflows, enhance patient experiences and achieve quality objectives, and Boston Medical Center , a private, not-for-profit academic medical center in New England, today released metrics from an ongoing remote patient monitoring program for new moms at high-risk of postpartum hypertension.
  • To address this challenge, Boston Medical Center leveraged the Rimidi platform to bring remotely-generated patient data from cellular-connected blood pressure cuffs into their clinical workflow.
  • Boston Medical Center (BMC) is a private, not-for-profit, 514-bed, academic medical center that is the primary teaching affiliate of Boston University School of Medicine.
  • Boston Medical Center and Boston University School of Medicine are partners in Boston HealthNet 12 community health centers focused on providing exceptional health care to residents of Boston.

Chung-Ang University Study Reports Hepatic Toxicity from Endocrine Disrupting Chemical Mixtures

Retrieved on: 
Friday, August 5, 2022

Bisphenol A (BPA) and phthalates, which are widely used in consumer products including plastics, aluminum cans, pharmaceuticals, and cosmetics, are well-known EDCs.

Key Points: 
  • Bisphenol A (BPA) and phthalates, which are widely used in consumer products including plastics, aluminum cans, pharmaceuticals, and cosmetics, are well-known EDCs.
  • Since both BPA and phthalates are structurally similar to steroid hormones that regulate chemical signaling in the body, they are capable of manipulating and disrupting hormonal functions.
  • Studies involving animal models and human urine samples have confirmed the positive correlation between exposure to individual EDCs and abnormal liver function.
  • "Our study tried to change the conventional toxicological approach and we hope it has an enormous impact on regulatory and public health perspectives," says Prof. Pang.