Tropifexor

TANDEM study shows potential of HistoIndex SHG/TPE imaging and AI-based technology in evaluating the effects of combination therapy for NASH

Retrieved on: 
Thursday, June 15, 2023
Photon, Steatosis, EASL, FXR, CET, NASH, Second-harmonic imaging microscopy, Research, Inflammation, Tropifexor, Congress, Fibrosis, HIV disease progression rates, Patient, Artificial intelligence, CCR5, TANDEM, Fatty liver disease, Digital, AI, Newcastle University, CCR2, SHG, Cenicriviroc, Medical imaging

The study, published recently in Hepatology , compared the effectiveness of Tropifexor plus Cenicriviroc combination therapy versus monotherapy1.

Key Points: 
  • The study, published recently in Hepatology , compared the effectiveness of Tropifexor plus Cenicriviroc combination therapy versus monotherapy1.
  • The study found that the AI-based analysis using SHG/TPE digital pathology was able to detect effects seen in different zones of the liver lobule that may not have been detected using conventional microscopy.
  • The fully quantitative co-localization and zonal assessment has the potential to provide greater details in evaluating the effects of combination therapy for NASH.
  • Tropifexor is a selective agonist of farnesoid X receptor (FXR), which regulates bile acid metabolism and inflammation.

Non-Alcoholic Steatohepatitis (NASH) Global Clinical Trials Review, H2, 2020 - ResearchAndMarkets.com

Retrieved on: 
Friday, June 18, 2021
Pharmaceutical, Health, Clinical trials, Medical specialties, Health, Hepatitis, Steatohepatitis, Non-alcoholic fatty liver disease, Clinical trial, Nash, Tropifexor

The "Non-Alcoholic Steatohepatitis (NASH) Global Clinical Trials Review, H2, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Non-Alcoholic Steatohepatitis (NASH) Global Clinical Trials Review, H2, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Non-Alcoholic Steatohepatitis (NASH) Global Clinical Trials Review, H2, 2020" provides an overview of Non-Alcoholic Steatohepatitis (NASH) Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Non-Alcoholic Steatohepatitis (NASH).
  • The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.

Metacrine Announces Publication of MET409 NASH Proof-of-Concept Study Results in the Journal of Hepatology

Retrieved on: 
Tuesday, February 16, 2021
Medical specialties, Hepatitis, Chemical compounds, Clinical medicine, Steatohepatitis, Non-alcoholic fatty liver disease, Nash, Tropifexor, Obeticholic acid

Metacrine has developed a proprietary FXR platform utilizing a unique chemical scaffold, which has demonstrated a differentiated and improved therapeutic profile in the clinic.

Key Points: 
  • Metacrine has developed a proprietary FXR platform utilizing a unique chemical scaffold, which has demonstrated a differentiated and improved therapeutic profile in the clinic.
  • MET409 is a once-daily, orally administered FXR agonist that is being evaluated as both a monotherapy and a combination therapy for the treatment of NASH.
  • The Journal of Hepatology article, entitled A structurally optimized FXR agonist, MET409, reduced liver fat content over 12 weeks in patients with non-alcoholic steatohepatitis , was published online on February 11, 2021.
  • The companys two product candidates, MET409 and MET642, are currently being investigated in clinical trials as potential new treatments for non-alcoholic steatohepatitis (NASH).

Global Liver Institute Releases Comprehensive U.S. NASH Action Plan

Retrieved on: 
Tuesday, February 9, 2021
Medical specialties, Hepatitis, Clinical medicine, Steatohepatitis, Non-alcoholic fatty liver disease, Fatty liver disease, Liver, Nash, Tropifexor

Washington, DC, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Global Liver Institute (GLI) and the GLI NASH Council have released the U.S. NASH Action Plan to comprehensively address nonalcoholic steatohepatitis (NASH), the advanced form of nonalcoholic fatty liver disease (NAFLD), and its impact on patients and families, public health, and the economy.

Key Points: 
  • Washington, DC, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Global Liver Institute (GLI) and the GLI NASH Council have released the U.S. NASH Action Plan to comprehensively address nonalcoholic steatohepatitis (NASH), the advanced form of nonalcoholic fatty liver disease (NAFLD), and its impact on patients and families, public health, and the economy.
  • Recommendations from the U.S. NASH Action Plan for GLI NASH Council members and the larger health community include:
    Education increasingly tailored for at-risk patient populations, in-language and in-culture.
  • Global Liver Institute (GLI) is a 501(c)(3) tax-exempt not-for-profit organization, headquartered in Washington, D.C., United States, with offices in the U.S. and Europe.
  • GLI's vision is for liver health to take its place on the global public health agenda commensurate with its prevalence and impact.

Metacrine Reports Positive Results from Phase 1 Trial of MET642

Retrieved on: 
Thursday, December 17, 2020
Chemical compounds, Medical specialties, Organic compounds, Hepatitis, Non-alcoholic fatty liver disease, Obeticholic acid, Tropifexor

Based on the Phase 1 findings, Metacrine plans to advance two dose levels of MET642 3 mg and 6 mg in a 16-week, randomized, placebo-controlled Phase 2a monotherapy trial enrolling up to 180 patients with NASH.

Key Points: 
  • Based on the Phase 1 findings, Metacrine plans to advance two dose levels of MET642 3 mg and 6 mg in a 16-week, randomized, placebo-controlled Phase 2a monotherapy trial enrolling up to 180 patients with NASH.
  • Metacrine, Inc. (Nasdaq: MTCR) is a clinical-stage biopharmaceutical company building a differentiated pipeline of therapies to treat liver and gastrointestinal (GI) diseases.
  • The companys most advanced programs, MET409 and MET642, target the farnesoid X receptor (FXR), which is central to modulating liver and GI diseases.
  • Both MET409 and MET642 are currently being investigated in clinical trials as potential new treatments for non-alcoholic steatohepatitis (NASH).

Gannex Received U.S. FDA Fast Track Designation for Its NASH Drug Candidate ASC42，an FXR Agonist

Retrieved on: 
Monday, December 14, 2020
Branches of biology, Life sciences, Biology, Receptor agonists, Transcription factors, Pharmacodynamics, Farnesoid X receptor, FXR, Fast track, Agonist, Food and Drug Administration, Tropifexor

This Fast Track designation represents FDA's recognition of ASC42's potential in addressing these unmet medical needs for NASH patients.

Key Points: 
  • This Fast Track designation represents FDA's recognition of ASC42's potential in addressing these unmet medical needs for NASH patients.
  • Gannex received the investigational new drug application (IND) approval for ASC42 from the U.S. FDA in October this year.
  • ASC42is an in-house developednovel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential.
  • "We are thrilled that the FDA granted Fast Track designation for our FXR agonist ASC42 which is discovered and developed by our in-house talented R&D team," said Dr. Jinzi J. Wu, "This critical recognition by FDA will accelerate global development of ASC42, a potential best-in-class FXR agonist."

Histoindex's AI-Based Platform Demonstrates Zonal Quantification and Histological Characterization of Fibrosis Improvements in Patients With Nonalcoholic Steatohepatitis (NASH)

Retrieved on: 
Wednesday, November 18, 2020
Health sciences, Medicine, Chemical compounds, Clinical research, Biopsy, Interventional radiology, Tropifexor, Clinical trial, Placebo

HistoIndex's quantitative analyses revealed novel aspects of improvement of NASH fibrosis beyond the conventional scoring of liver biopsies for Tropifexor-treated patients.

Key Points: 
  • HistoIndex's quantitative analyses revealed novel aspects of improvement of NASH fibrosis beyond the conventional scoring of liver biopsies for Tropifexor-treated patients.
  • In addition, zonal quantification of fibrosis changes showed a fibrosis improvement in the intermediary area of Zone 2 for Tropifexor-treated patients compared with placebo.
  • Results of zonal quantification using SHG in NASH Phase 2 clinical trials with other pharmaceutical companies have been previously reported and presented.
  • This opens the possibility to measure changes in fibrosis in clinical trials in a manner which more closely reflects the dynamic nature of fibrosis than classical methods."

Histoindex's AI-Based Platform Demonstrates Zonal Quantification and Histological Characterization of Fibrosis Improvements in Patients With Nonalcoholic Steatohepatitis (NASH)

Retrieved on: 
Wednesday, November 18, 2020
Health sciences, Medicine, Chemical compounds, Clinical research, Biopsy, Interventional radiology, Tropifexor, Clinical trial, Placebo

HistoIndex's quantitative analyses revealed novel aspects of improvement of NASH fibrosis beyond the conventional scoring of liver biopsies for Tropifexor-treated patients.

Key Points: 
  • HistoIndex's quantitative analyses revealed novel aspects of improvement of NASH fibrosis beyond the conventional scoring of liver biopsies for Tropifexor-treated patients.
  • In addition, zonal quantification of fibrosis changes showed a fibrosis improvement in the intermediary area of Zone 2 for Tropifexor-treated patients compared with placebo.
  • Results of zonal quantification using SHG in NASH Phase 2 clinical trials with other pharmaceutical companies have been previously reported and presented.
  • This opens the possibility to measure changes in fibrosis in clinical trials in a manner which more closely reflects the dynamic nature of fibrosis than classical methods."

DURECT Corporation Announces Additional Safety Data and Efficacy Signals from Phase 1b Clinical Trial of DUR-928 in NASH Patients at The Liver Meeting Digital Experience™ 2020

Retrieved on: 
Friday, November 13, 2020
Medical specialties, Hepatitis, Clinical medicine, Medicine, Steatohepatitis, Non-alcoholic fatty liver disease, Carboxylic acids, Obeticholic acid, Tropifexor

DUR-928 was orally administered daily at 50 mg (n=23), 150 mg (n=21), or 600 mg (300 mg BID (n=21)).

Key Points: 
  • DUR-928 was orally administered daily at 50 mg (n=23), 150 mg (n=21), or 600 mg (300 mg BID (n=21)).
  • Patients in this trial were dosed daily for 4 weeks and followed up for an additional 4 weeks.
  • DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and nonalcoholic steatohepatitis (NASH).
  • Further information regarding these and other risks is included in DURECT's Form 10-Q filed on November 3, 2020 under the heading "Risk Factors."

Gannex Received U.S. IND Approval for Its NASH Drug Candidate ASC42，an FXR Agonist

Retrieved on: 
Monday, October 12, 2020
Chemical compounds, Transcription factors, FXR, Farnesoid X receptor, Medication, Branches of biology, Chemistry, Tropifexor, Fexaramine

ASC42 is an in-house developednovel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential.

Key Points: 
  • ASC42 is an in-house developednovel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential.
  • Gannex has two additional drug candidates at clinical stage in its NASH pipeline, ASC40 and ASC41.
  • We will continue our commitment to patient-centric innovation and develop new medicines to address the unmet needs in NASH treatment."
  • NASH: global development of novel drug candidates against three different targets FASN, THR-beta and FXR, which are expected to be used alone or in combination.