IMM124E



NAME OF DRUG : IMM124E

ALSO KNOWN AS : IMM124E

LABORATORY : IMMURON

STATUS AND ADVANCEMENT

Type of drug : anti-LPS antibodies and adjuvants

Clinical trials advancement : Initiating Phase 3

The drug got the Breakthrough Therapy Status granted by the FDA

Estimated time to market : 54 months.

LABORATORY ABSTRACT ON THE DRUG

Immuron's unique oral immunotherapy bridges the the lumen with the systemic immune system The gut is the largest lymphoid organ in the body and is responsible for differentiating antigenic signals against the high “background noise” (“good” versus “bad” antigens) Immurons' basic platform works by suppressing inflammation. Delivering continuous signals through the gut wall using the Microbiome to deliver them.

KNOWN RESULTS

In March 2018 IMMURON published mid-stage Study data showed treatment with IMM-124E (bovine colostrum) produced a statistically significant reduction in serum lipopolysaccharide (LPS) levels compared to placebo. LPS is associated with the progression of NASH. Specifically, 64.3% of patients in the treatment group experienced at least a 15% decrease in serum LPS versus 34.5% for placebo (p=0.018).

36.4% of patients receiving the higher dose (1200 mg) of IMM-124E experienced at least a 30% drop in average serum ALT (enzyme biomarker for liver damage) compared to 13.6% for placebo (p value not reported). In all patients, IMM-124E's effect on ALT did not statistically significantly separate from placebo (p=0.107). Parsing the data produced a statistically valid treatment effect in patients will elevated baseline ALT (p=0.048).

IMM-124E also produced statistically significant reductions in another enzyme called AST and a protein called CK-18, both of which are associated with liver damage (same criteria as ALT: proportion of patients vs. placebo).

NASHBIOTECHS COMMENT

FIRST YOU SHOULD NOTICE THAT DATA PUBLISHED ARE NOT DONE ON ITT POPULATION BUT ON BALANCED SITES (94 patients),  30% ot patients are excluded and no data is provided on ITT population( 133 patients). 

Only steatosis data are based on PP population (102 patients)

On published results for Primary endpoints 

Percentage Fat Content of the Liver NOT REACHED ON ITT AND PP POPULATION

Serum Alanine Aminotransaminase (ALT) 30% reduction NOT REACHED ON ITT (133) AND PP(102)  POPULATION NOR ON BALANCED SITES (94) BUT ONLY ON SELECTED SUB POPULATION

On Secondary Endpoint  

Mean change from Baseline of serum AST :   30% reduction NOT REACHED ON ITT (133) AND PP(102)  POPULATION NOR ON BALANCED SITES (94) BUT ONLY ON SELECTED SUB POPULATION

On Other Outcome Measures

Serum Concentrations of Lipopolysaccharide (LPS) : IMPROVED (>= 15% decrease) ON BALANCED SITES (94) NO DATA ON ITT AND PP POLULATION 

CK-18 fragments : IMPROVED (>= 15% decrease) ON BALANCED SITES (94) NO DATA ON ITT AND PP POLULATION 

 

Decrease in LPS and  CK18 where not primary targets of the trial, their decrease can be encouraging but one should notice that it is only on a sub part (70%) of the ITT population.

primary and secondary endpoints published are a failure except the for safety 

To NB opinion those new results are well presented but not good by far !

 

 

RECENT NEWS ON IMM124E

2018-03-07 : Immuron Reports Positive Results in NASH Clinical Trial

2017-02-06 : Immuron enrols first patient in paediatric fatty liver trial in the U.S.

SOME PUBLICATIONS RELATED WITH IMM124E

March 2017 : Probiotics may delay the progression of nonalcoholic fatty liver disease by restoring the gut microbiota structure and improving intestinal endotoxemia

SOME NASHBIOTECHS POINTS OF VIEW RELATED WITH IMM124E

July 2017 : IMMURON INTERMIM ANALYSYS RESULTS ???

October 2016 : NASH COMBOs ARE THE WAY


WWW.NASHBIOTECHS.COM  -  Copyright G DIVRY 2015-2016  - Contact and TERMS OF USE