CLDF Title
Home | Contact Us | Bookmark
  HBV   HCC   HCV   HE   NASH   PBC   OTHER
About CLDF Centers of Educational Expertise  
Live CME Meetings Webcasts Slide Library Abstract Library Conference Highlights
 
Back  
 
Reuters Health Information: Israeli company Galmed gets positive trial results for liver drug

Israeli company Galmed gets positive trial results for liver drug

Last Updated: 2018-06-12

By Reuters Staff

TEL AVIV (Reuters) - Galmed Pharmaceuticals said on Tuesday patients in a mid-stage trial for its treatment for non-alcoholic steatohepatitis (NASH), a fatty liver disease linked to obesity, showed a statistically significant reduction in liver fat.

The results will allow Galmed to meet with regulators as soon as possible and discuss a pivotal Phase 3 study design, Galmed CEO Allen Baharaff said.

The company's shares were up 220 percent at $22.42 in premarket trade on Nasdaq.

Patients in the Phase 2b study of Galmed's drug Aramchol had magnetic resonance spectroscopy (MRS) and biopsy at the start of the study and again after 52 weeks. Galmed said data strongly supported the advancement of Aramchol 600 mg to an advanced Phase 3 trial. Aramchol is an oral, once-daily, liver-targeted SCD1 modulator.

Significantly more patients treated with Aramchol 600 mg versus a placebo showed NASH resolution without worsening of fibrosis in the 52-week biopsy, Galmed said.

Statistically significant reductions in liver enzymes ALT and AST were demonstrated in Aramchol 400 mg and 600 mg versus a placebo, it also said.

According to a company statement, "Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating down regulation of the three key pathologies of NASH; steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by down regulation of steatosis and directly on human collagen producing cells. Aramchol has been granted by the FDA Fast Track designation status for the treatment of NASH."

 
 
 
 
                               
 
HBV
Webcasts
Slide Library
Abstract Library
 
HCC
Slide Library
Abstract Library
 
 
HCV
Webcasts
Slide Library
Abstract Library
 
 
HE
Webcasts
Slide Library
Abstract Library
 
NASH
Webcasts
Slide Library
Abstract Library
 
 
PBC
Webcasts
Slide Library
Abstract Library
 
 
OTHER
Webcasts
Slide Library
   
   
 
About CLDF
Mission Statement
Board of Trustees
Board of Advisors
CLDF Sponsors & Supporters
 
Other Resources
Liver News Library
Journal Abstracts
Hep C Link to Care
 
Centers of
Educational Expertise
Hepatology
Substance Use Disorder
             
CLDF Follow Us
   
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2018 Chronic Liver Disease Foundation. All rights reserved. This site is maintained as an educational resource for US healthcare providers only.
Use of this Web site is governed by the Chronic Liver Disease Foundation terms of use and privacy statement.