ARAMCHOL



NAME OF DRUG : ARAMCHOL

LABORATORY : GALMED

STATUS AND ADVANCEMENT

Type of drug : FABACs

Clinical trials advancement : Ongoing Phase 2b

The drug got the Fast Track Status granted by the FDA

Estimated time to market : 68 months.

LABORATORY ABSTRACT ON THE DRUG

Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, causing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in numerous animal species and models by leading Israeli and European research groups led by the Company's founder, the late Prof. Tuvia Gilat. Recently, anti-inflammatory and anti- fibrotic effects were observed in mice treated with Aramchol using a methionine-choline deficient (MCD) diet treatment model and rats' prevention thioacetamide (TAA) model.

HISTORY AND ANALYSIS

Their drug candidate, the ARAMCHOL,  is a FABACs is synthetic combination:

  • cholic acid which is one of two major bile acids produced by the liver, where it is synthesized from cholesterol.
  • arachidic (eicosanoic) is a saturated fatty acid present in the peanut oil and other vegetable oils, and fish oils. It acts on liver metabolism

The Fabac's were originally approached to prevent the crystallization of cholesterol.

It has been tested in a Phase 2a

In a sample of 60 patients and three arms (20 patients per arm)

  • An arm dosed at 300 mg / day
  • An arm dosed at 100 mg / day
  • Placebo arm 

Inclusion criteria for this study were :

  • Patients with NAFLD or NASH (based on biopsy)
  • Elevated ALT
  • Steatosis and a lower fibrosis score of 4 (no cirrhosis)
  • A BMI <35.

All the centers wich have conducted the study are located in Israel were the GALMED company is located.

The criteria for the study were the change in triglyceride levels, metabolic and endothelial measures

No histological measures were planned in this study

 

Results

The study only demonstrated a reduction of lipids in the liver

  • For arm 100 mg (-2.89%) and not statistically significant
  • For arm 300 mg (-12.57%)

 

And GALMED also announces a trend of improvement (not statistically significant) in other parameters such as ALT, HOMA, endothelial function and adiponectin.

They do not mention the evolution of the lipid yet emphasized in preclinical testing in mice.

 

To summarize this phase 2a:

The ARAMCHOL in its clinical testing phase 2a, has demonstrated an ability to lower the fat (measured by MRI) in the liver by 12% with a 300 mg / day dose. No histological measure has been performed, so it is impossible to know whether this improvement of steatosis measured by MRI has a measurable effect on the liver histology.

Based on this study, GALMED initiated a Phase 2b targeting NASH:

 

This study (NCT02279524) includes a sample of 240 patients in 3 arms

  • An arm dosed at 600 mg / day
  • An arm 400 mg / day
  • Placebo arm

 

 The main inclusion criteria are as follows

  • BMI> 25 and <40
  • Type 2 Diabetes
  • NASH based on biopsy confirmed by centralized reading
  • NAS score> 4
  • Fat liver> 5.5% measured by MRI
  • No Cirrhosis 

This study takes place over 75 sites in 9 countries

USA, France, Italy, Peru, Mexico, Romania, Israel, Germany, Chile.

It should be noted that 75 sites and 240 patients three arms will make it difficult or virtually impossible to have some balanced sites which can be problematic.

Primary measures are:

  • Measurement of rate of change of triglycerides in the liver by MRI measurement
  • Secondary measures are numerous but has noted the two main histological measures are :
  • The improvement in NAS score a minimum of 2 points
  • The resolution of NASH (not defined)
  • The study duration is 52 weeks and will end in June 2017

 

RECENT NEWS ON ARAMCHOL

2017-01-09 : Galmed Pharmaceuticals Completes Patient Recruitment for ARREST Phase IIb NASH study

SOME PUBLICATIONS RELATED WITH ARAMCHOL

SOME NASHBIOTECHS POINTS OF VIEW RELATED WITH ARAMCHOL

October 2016 : NASH COMBOs ARE THE WAY

August 2016 : STATUS REPORT ON NASH (August 2016)

May 2016 : UPDATE ON THE RACE TO NASH MARKET (May 2016)

November 2015 : GILEADs POSSIBLES STRATEGIES IN NASH

October 2015 : THE NEW DEFINITION OF NASH STRIKE THE NASH PLAYERS

September 2015 : NASH ! TREATMENT’S STRATEGIES AND COMPETITION


WWW.NASHBIOTECHS.COM  -  Copyright G DIVRY 2015-2016