Fenix,

The eGFR and alkaline phosphatase clinical data from the post-hoc analysis of the combined SUSTAIN and ASSURE trials was published last year (link to paper). Should be same data as in the Dr. Kamyar Kalantar-Zadeh presented at the ERA-EDTA symposium (you also linked to the slides).

They all say the same thing. In the rather small post-hoc analysis of 48 CKD patients from combined SUSTAIN (24-week study) and ASSURE (26-week study), there were 13 placebo and 35 apabetalone patients. The apabetalone group increased eGFR by 3.4% vs. baseline, which was significant (p=0.04). The placebo group decreased eGFR by 5.8% vs. baseline, which was not significant (p=0.6). The between group comparison (placebo vs. apabetalone) was not significant (p=0.3). So while it is correct to say there was no statistically significant difference between apabetalone and placebo groups, it is also correct to say that the apabetalone group experience a statistically significant increase in eGFR vs. baseline.

The BETonMACE CKD sub-study will have 259 patients (~ half placebo, half apabetalone) and you can see the baseline data for this study here. With the larger number of patients and longer treatment period, this BETonMACE CKD sub-study will have much better power to detect a difference.

As for changes in hsCRP due to apabetalone.....I was just looking this up yesterday. In the combined SUSTAIN and ASSURE analysis, apabetalone and placebo groups did not significantly differ for change in hsCRP. However, hsCRP decreased in both groups compared to baseline (28.4% decrease in apabetalone group; 22.4% decrease in the placebo group). Baseline hsCRP was about 2.4 mg/dL in this combined analysis. Importantly, in the ASSURE analysis when limited to analysis of patients with baseline hsCRP above 2 mg/dL...."In the RVX-208 treated patients, there was a 60% reduction (p<0.0001) in hsCRP vs. baseline and (p=0.054) vs. placebo."

The BETonMACE patients will likely have higher baseline hsCRP than the patients in SUSTAIN and ASSURE. So there is a good chance that apabetalone will elicit a significant reduction in hsCRP vs. placebo in BETonMACE. But even if it is not significant, circulating hsCRP is not the only measure of anti-inflammatory effect. Beyond direct hsCRP measures, Resverlogix has documented several examples of apabetalone eliciting anti-inflammatory effects using SOMAscan proteomic profiling of clinical plasma samples, and studies of inflammatory proteins and gene expression profiling in primary human hepatocytes, whole human blood, monocyte cell culture, etc., treated with apabetalone. Take a look at the publications and posters pages. Very impressive, in my opinion. 

BearDownAZ