Re-posting this message as it is very appropriate to the upcoming BETonMACE top-line data announcement. We don't know for sure what information, if any, beyond a statement of meeting or not meeting the primary endpoint will be included in the top-line data announcement. Will the %RRR be stated? Will any pre-specified sub-group analysis data be stated (i.e. rosuvastatin sub-group)? Will any secondary endpoint data be stated? Will either of the CKD or cognition sub-study results be stated? If yes for some of the above non-primary endpoint data, will it be just statement of meeting or not meeting endpoint or more details. Most likely a bare bones top-line just stating whether or not the primary 3-point MACE outcome was met. But there could be more......

Most of the time in cardiovascular outcomes trials, the news release is simply a statement that the trial succesfully met its primary endpoint without any futher details in the top-line. In these cases, the %RRR and other detailed info are shared at a later date at a major scientific conference. This was true for CANTOS trial for canakinumab, EMPA-REG OUTCOME trial for empagliflozin, DECLARE TIMI-58 trial for dapagliflozin, REWIND trial for dulaglutide, SUSTAIN-6 trial for injectable semaglutide, LEADER trial for liraglutide, FOURIER trial for evolocumab and REVEAL trial for anacetrapib. These are just several examples and are not exhaustive of recent CVOTs. However, the point is that the norm is to have bare minimum info in the top-line and have details come out at a later date such as full data presentation at major scientific conference. In my opinion, this is the most likely format of news release that we will see for BETonMACE.

Amarin's REDUCE-IT trial for Vascepa was an outlier. It reported the %RRR for its primary outcome 5-point MACE in the top-line news release, but didn't release any other details beyond that until the full data presentation at a later date. Amarin could have just news released that they met their primary endpoint without giving the %RRR. This would have likely been met with more reserved enthusiasm, since this primary endpoint was for 5-point MACE and not 3-point MACE and many may have expected a much more modest %RRR. Amarin bucking the trend really makes me wonder if Resverlogix will do the same with BETonMACE. 

What sometimes happens is that for in-same-class therapies that are not the first-in-class to report CVOT results, more detailed or full data are reported at same time as top-line data news release. This was the case for the ODYSSEY trial for alirocumab, CANVAS trial for canagliflozin and PIONEER 6 trial for oral semaglutide. Since BETonMACE for apabetalone will be a first-in-class to report CVOT for any BET inhibitor, and the first BET inhibitor to complete a Phase 3 trial in any clinical area, I don't expect the BETonMACE trial to go down this route.

So I hope you can appreciate that there are a few different variants of top-line data news releases. Add onto this the uncertainty as to whether the CKD and/or cognition sub-study results will be included in the top-line data news release, and that adds on a few more variants.

BearDownAZ