Since ~90% of the patients in BETonMACE have normal kidney function (median 99, mean above 100), the total population eGFR data is dominated by these patients and in my opinion masks/hides the 10% of patients w/ baseline eGFR<60 that we want to see. That is why I keep saying that jury is still out on these CKD patients. Going from great mean eGFR of above 100 at basline in both apabetalone and placebo in total population to a smidge -0.4 lower in the apbetalone total population at 100 weeks (still mean above 100) and a smidge 2.1 higher in the placebo total population (still mean above 100) is really clinically/physiologically meaningless in my opinion. These observations in the total population could just be noise/random effects. The p-value on the total population change was significant, but not great (p=0.03).

The CKD sub-study is going to look at eGFR at many more time points (evaluated at screening, 24 weeks, 52 weeks, 76 weeks, 100 weeks and at the termination of the trial), so there will be much more comprehensive data to show for the CKD subgroup. The best comparison to Phase 2 would be the 24 week time point in BETonMACE, since these Phase 2s were 6 months or less.

BDAZ