GR_MD_02



NAME OF DRUG : GR_MD_02

ALSO KNOWN AS : GR_MD_02

LABORATORY : GALECTIN

STATUS AND ADVANCEMENT

Type of drug : Galectin Inhibitor

Clinical trials advancement : Initiating Phase 3

The drug got the Fast Track Status granted by the FDA

Estimated time to market : 54 months.

LABORATORY ABSTRACT ON THE DRUG

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.

HISTORY AND ANALYSIS

After failing their phase 2b NASH (NASH -FX) GALECTIN reported that NASH-CX ( cirrhosis patients) did not reach the primary endpoint,  it seems that NASH treatment is ended for GR-MD-02 but regarding the detailled results of the trial, a new life is mayby opening for GR-MD-02 on advanced leaver fibrosis treatment (induced by NASH or not) !

 

 

TRIALS IN COURSE AND PLANNED

GALECTIN is negociating with FDA a phase 3 on advanced fibrosis

 

RECENT NEWS ON GR_MD_02

2017-08-14 : Galectin Therapeutics Reports 2017 Second Quarter Financial Results and Provides Business Update

2016-09-25 : GALECTIN Ph2a NASH FX TRIAL FAIL ! STILL IN THE RACE WITH ONGOING NASH CX TRIAL

2016-08-02 : Galectin Therapeutics Announces Completion of Patient Recruitment in its Phase 2 Trial with GR-MD-02 in NASH Patients with Cirrhosis

SOME PUBLICATIONS RELATED WITH GR_MD_02

September 2018 : A multicenter, randomized, double-blind, placebo-controlled trial of Galectin-3 inhibitor (GR-MD-02) for one year in patients with NASH cirrhosis and portal hypertension The NASH-CX Trial

June 2018 : A critical review of endpoints for non-cirrhotic NASH therapeutic trials

October 2016 : Randomised clinical study: GR-MD-02, a galectin-3 inhibitor, vs. placebo in patients having non-alcoholic steatohepatitis with advanced fibrosis

SOME NASHBIOTECHS POINTS OF VIEW RELATED WITH GR_MD_02

October 2016 : NASH COMBOs ARE THE WAY


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