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** BETonMACE Phase 3 Cardio Outcomes Trial for Apabetalone Has Reached its Targeted 250 MACE Events ** Top-Line Data Expected Mid-Year 2019 https://clinicaltrials.gov/ct2/show/NCT02586155

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Fenix,

Welcome to Agoracom. Tada had a great reply to you. I'll add a few more resources for you that are hyperlinked below.

The link library is a great resource of archived posts, analyst reports, presentations, articles, etc.

The publications and posters pages on the Resverlogix website have a ton of good stuff. These really cover the multiple facets of apabetalone action on apo-AI/HDL/reverse cholesterol transport, complement, coagulation, vascular inflammation, vascular calcification (including alkaline phosphatase), glucose metabolism, kidney function (i.e. changes in eGFR), and cognition (i.e. changes in MoCA score).

For a more comprehensive list of publications, also see NCBI PubMed list here.

A list of archived and potential future 2019 events can be found here

For background on the BETonMACE trial and the sub-studies, see the ClinicalTrials.gov listing as well as the posters from AHA 2018, ACC 2019, AAIC 2018, and ERA-EDTA 2018 on the basline data and study design.

For some great webinars given by some of the experts in the field, see the "Epigenetics in CKD & CVD: A potential breakthrough therapy?" ERA-EDTA 2018 symposium presentation and "LDL-c: Done Deal, Next Epigenetics?" ESC 2018 symposium presentation.

A post of mine from about a year and a half ago summarizes the Evolution of Apabetalone.

You had asked in another post "Looking through the old posts I got the impression the drug in previous phase two studies was more effective for the sicker patients, any thoughts as to why?" Those symposium presentations above explain that certain disease states (i.e. diabetes, chronic kidney disease, other inflammatory diseases) elicit epigenetic changes to DNA and associated BET bromodomain-mediated changes in gene expression that are reveresed by BET inhibitors such as apabetalone.

As for the interim analyses.....I thought Growacet summed it up nicely the other day in this post. Originally, there was a planned futility interim analysis at 50% of events (125 events) and a sample size re-estimation analysis at 75% of events. Well, Lucy kept yanking that football away. What's done (or not done) is done. It's too late now with 250 events anticipated this month. As you pointed out, and as the company has recently stated, skipping these interim analyses will save them the statistical penalty during BETonMACE final analysis. However, I wouldn't confuse this with confidence in the results. One could also argue that they are skipping the interim analyses in order to maximize the chances that a borderline statistically significant results ends up on the side of significance.

BearDownAZ 

 

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