"In BETonMACE we are testing for a very small subset of those [Cabel was referring to a larger total CKD population]. Do you think in phase 3 for CKD they will test for a bigger population or just repeat the BETONMACE subset,...?"

Cabel, you are correct that BETonMACE does not include patients from all stages of CKD. Per the BETonMACE trial exclusion criteria, patients are excluded if they have "Evidence of severe renal impairment as determined by either eGFR<30 mL/min/1.7m2 at Visit 1 or current need for dialysis." This of course excludes the more severe forms of CKD (Stages 4 and 5) with eGFRs below 30 and those on dialysis. The BETonMACE CKD sub-study is focusing on those with Stage 3 CKD with eGFR of 30-60 mL/min/1.73m2. If apabetalone elicits an increase in eGFR, as well as lowering alkaline phosphatase and reducing MACE in these Stage 3 CKD patients, then it would be an obvious next step for the company to pursue a clinical trial focusing on these Stage 3 CKD patients to further validate these findings. As a reminder, one of the pre-specified analyses of the primary MACE outcome is separately analyzing the MACE reduction in those with GFR >60 mL/min from those with < 60 mL/min. So similar to the rosuvastatin vs. atorvastatin pre-specified analysis of the MACE outcome, in which rosuvastatin+apabetalone may outperform, atorvastatin+apabetalone, BETonMACE may reveal that MACE reduction in those w/ eGFR<60 mL/min is even more impressing than in those with eGFR >60 mL/min.

Resverlogix hasn't been neglecting the more severe CKD. There is currently an apabetalone Phase 2a BETonRENAL trial (not yet recruiting) listed on ClinicalTrials.gov entitled "A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis" that would explore the benefit of apabetalone in dialysis patients. It has been listed on ClinicalTrials.gov for almost 2 years and has been discussed by the company for even longer. My guess is that they are waiting for the BETonMACE trial results before they finalize plans to start this proposed renal trial. This proposed trial on ClinicalTrials.gov seems to be a follow up of the New Zealand Phase 1 trial in patients with stage 4 or 5 CKD that was recently published in an article entitled "Benefit of Apabetalone on Plasma Proteins in Renal Disease." This data has been regularly highlighted by Resverlogix in their company presentations, so it seems that they are excited about pursuing apabetalone in these more severe forms of CKD. 

Also keep in mind that it may be a little premature to be talking about Phase 3 renal/CKD trials for apabetalone. Resverlogix may need to complete Phase 2 first before proceeding to Phase 3. 

BearDownAZ