"So, are (or could) the CKD and VCD therefore be classified as P2 clinical trials within the P3 BoM trial?  They seem comprehensive enough although I recognize there is likely more to it than that. However, the clinical trial history chart on the RVX website suggests that the P2 clinical trials will follow the P3 BoM trial, which runs counter to that argument. If the CKD and VCD subsets are then simply ‘exploratory’ with potential P2 trials still to come, then it would seem we still have a long way to go to confirming whether ABL has a positive impact on either of those indications would it not?""

The BETonMACE cognition sub-study is not necessarily a vascular cognitive dementia (VCD) population. The cognition subgroup in BETonMACE is just based upon baseline MoCA score (see here and here) without screening for a particular type of cognitive disease. Therefore, if Resverlogix wants to develop apabetalone specifically as a therapy for VCD, then a VCD focused trial will be necessary and this will likely need to start in Phase 2.  

I've touched on the CKD issue before in this post and this post in reply to Cabel's original thread post "What is amazing is the size the Chronic Kidney disease market,..." Take a look a those posts.

If Resverlogix sticks to low-HDL, diabetic patients with recent ACS event and stage 3 CKD, then they might be able to go straight to Phase 3 or even get marketing/label approval for improved renal function (assuming that the BETonMACE CKD sub-study is successful). But the more Resverlogix veers away from the BETonMACE study population [normal HDL not just low-HDL, non-diabetic not just diabetic, primary prevention not just secondary prevention, longer time since last ACS event, stage 4/5 CKD vs. stage 3 CKD, end stage renal disease with hemodialysis, inherited/rare kidney disease (i.e. Reata)], then the more burden of proof for safety and efficacy. Phase 3 is often confirmatory. New populations and indications will likely require doing earlier phase (1 or 2) before going to Phase 3.

There is no cognition trial even listed on ClincialTrials.gov yet, so we can't even evaluate the details of the proposed VCD trial. The only renal trial listed on ClinicalTrials.gov right now is for end stage renal disease with hemodialysis (see listing here). That population is VERY different that the BETonMACE CKD sub-group and is not surprising that it would be starting in Phase 1/2. Once the BETonMACE CKD and cognition sub-studies report out, it is very likely that Resverlogix will use this info to revise and refine their follow up clinical plans.

BearDownAZ