IMMURON - INTERIM ANALYSIS RESULTS - ???

question-mark-2405218 1280


Here is the press news

MELBOURNE, Australia, July 10, 2017 (GLOBE NEWSWIRE) -- Australian biopharmaceutical company, Immuron Limited (ASX: IMC) (NASDAQ: IMRN), is pleased to announce safety and efficacy results of the interim analysis of its ongoing IMM-124E Phase II study in NASH.  The objectives of this analysis was to establish the safety of the compound and to provide a preliminary read on efficacy signals.

The NASH Phase II trial has enrolled 133 patients with the top-line results expected in 4Q2017.  The pre-planned analysis was triggered when 80 subjects completed treatment.

The demographics of the population analyzed in the interim analysis were balanced in all three groups (placebo, low dose -600mg- and high dose -1200mg-) including sex, race, age, height, weight, BMIs, HbA1c and baseline hepatic fat fraction (HFF). 

Highlights from the interim analysis are as follows:

  • IMM-124E was safe and there were no safety signals when compared to placebo.
  • The treatment was well tolerated and no subjects discontinued therapy due to side effects.
  • The IMM-124E 1200mg and  600mg groups, as well as the placebo group, all demonstrated a significant change of ALT at 24 weeks compared to baseline (p=0.0038, p=0.016 and p=0.0337).  However, no statistical difference was noted between the groups.
  • When accounting for all ALT values thoughout the study period, the area under the curve (AUC) was calculated, and when correcting for ALT baseline values (using ANCOVA), a trend (p=0.067) in improvement in ALT was noted in the 1200 mg group when compared to placebo 
  • When using the predicted ALT-AUC values, the overall AUC for ALT was statistically significantly lower for the 1200mg and 600mg groups (p=0.0036 and p=0.0075, respectively) when compared to placebo. 
  • The overall AUC for AST values, when corrected for baseline values, was also significantly lower in the 1200mg and 600mg dose groups (p=0.0036 and p=0.0098, respectively) when compared to placebo.
  • There was no evidence of systemic absorption of IMM-124E as assessed by circulating bovine immunoglobulin.
  • At the time of this interim analysis, no difference was noted in the hepatic fat fraction (HFF), which is  the study’s primary endpoint between the groups.  This is most likely attributable to the small sample size in this analysis.

Based on the results of the interim analysis, IMM-124E has demonstrated to be a non-absorbable, safe and tolerable compound in patients with NASH.  Early biochemical improvements in liver enzymes are noted, suggesting potential therapeutic benefit for treatment of NASH.  The DSMB recommendation was to continue the trial to completion, as there is no concern for safety or futility.


NASHBIOTECH COMMENT

Nothing !! 

the IMM124E is safe .. OK  but no any action on ALT or fat in the liver was noted!  even the supposed improvement mentionned vs placebo after retreatment is not statistically pertinent. 

Nothing !!


The good news is, as IMM 124E has no action on nothing , it seems very safe and the paediatric trial initiated months ago can continue.  

Not sure that childs will benefit from the product, but it is safe !!


The bad news is, the IMM124 effect on NASH and even NAFLD seems null,  and patients will need to find another way to cure their disease !



Share on StockTwits

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