Re: Rationale and Design of Apabetalone BETonMACE Trial
in response to
by
posted on
Jun 02, 2019 08:37AM
"Bear, what I am looking at is the period between the rationale and design publication date of March 2017 when the SPP for Amarin was $3.20, and when Amarin Corporation announced the results of Reduce-it on Nov 2018 when the SPP was $22.87. That's a span of 1 1/2 years. Or are we talking about something totally different here?"
Koo, you are incorrectly assuming that there is always a long lag period between rationale and design paper publication and announcement of top-line or full data. While I think it would be best for it to be published prior to top-line data (in order to help put BETonMACE, apabetalone and Resverlogix more on the radar), it could also come out sometime between top-line data and full data in order to more comprehensively describe the background on apabetalone, the residual risk in the study population, the baseline clinical values, the pre-specified primary, secondary and exploratory outcomes, the CKD sub-study, the cognition sub-study, the pre-specified sub-group comparisons on the primary outcome, and hopefully the statisical analysis plan. Either way, it serves the purpose to describe the who, what, when, where, why and how of BETonMACE and apabetalone.
Resverlogix and/or the BETonMACE clinical investigators have been presenting posters on the design and baseline data of the BETonMACE MACE, CKD and cognition study for some time now (see Resverlogix posters page or links below). For all we know, a BETonMACE rationale and design manuscript has been submitted to the target journal already and is somewhere in the peer-review process. It could be published any day now. As IR relayed to me, it is their goal to have it published before top-line, with top-line expected in the next 2.5 months (according to April 18th guidance).
2018 AHA Scientific Sessions
Cardiovascular Evaluation of the Selective Bet Inhibitor, Apabetalone, in ACS Patients With Diabetes: Baseline Characteristics of the BETonMACE CV Outcomes Study.
2019 American College of Cardiology’s Scientific Session
BET Protein Inhibition and Cognition: A Pre-Specified Substudy of the BETonMACE Phase 3 Trial Evaluating Apabetalone in Patients With Diabetes and Acute Coronary Syndrome.
2018 Alzheimer's Association International Conference (AAIC)
Apabetalone (An Epigenetic BET-Inhibitor Small Molecule): A Substudy Evaluating Effects on Cognition in Diabetes Patients with Cardiovascular Disease.
2018 European Renal Association European Dialysis and Transplant Association (ERA-EDTA) Congress
BETonMACE Chronic Kidney Disease Sub-Study: Effects of the Selective BET-Inhibitor Apabetalone on Kidney Function and MACE in Post-ACS Patients with Diabetes and Estimated Glomerular Filtration Rate Below 60.