At higher stages of disease progression 700mg woul
Post# of 146080
(Total Views: 351)
Posted On: 07/09/2024 6:06:13 AM
Quote:
At higher stages of disease progression 700mg would have the advantage.
With regards to the NASH trial , one of the greatest problems with it was that baseline level of disease were not acquired for the 700mg dosed arm.
Baseline level of disease was acquired for the 350mg dosed arms.
The 350mg dosed arms were divided into 2 groups. Those who were measured pre-trial to have a corrected T1 (cT1) > 875 but less than 950 and those who were measured pre-trial to have a corrected T1 (cT1) > 950.
This determination of the state of the patient's disease pre-trial was not made in the 700mg treated patients, nor was it made in the Placebo group.
For all we know, the Placebo group could have been filled with very sick patients, full of Stage 7 or 8 disease, and/or Cirrhosis. They also could have been near healthy with Stage 1 or 2 disease without any fibrosis. We really don't know their pre-trial status.
Now, with respect to the 700mg treated patients, I make an argument in Interpretation of NASH Prior to Liver Conference : as to why I believe that about 73% of the 700mg treated patients started off with rather Mild disease. That argument is made under the header, " 700 normal " in the post.
If we knew for sure that many of the 700mg treated patients were as sick as the 350mg treated patients, (actually, we do know that their cT1 > 800 as per trail parameters, but that is far less than the 875 of the 350mg treated patients). As we know, the patients who found the greatest improvement in cT1 were those whose pretrial cT1 was greater than 950. So if we knew this ahead of time, we would be better able to make a head to head comparison.
Therefore, it is imperative that they determine the levels of disease progression prior to initiating leronlimab treatment.
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