I watched the ESC symposium presentations. It was good background on the increased risk for CVD that diabetes and inflammation poses, the unmet need to treat the large residual CVD risk in these patients, background on the the basic science mechanisms of BET proteins and BET inhibitors, and an overview of the pre-clinical and clinical apabetalone data. Nothing new that we didn't already know.

Dr. Kausik Ray was still using the old BETonMACE trial design slide that indicates dosing up to 104 weeks instead of conveying that all patients will now stay on drug until the trial is completed as reflected in the recent ERA-EDTA and AAIC posters and re-iterated by Sarah at Resverlogix when I asked her about this.  

Dr. Ray did not mention the SSRA at all; however, at least 3 times Dr. Ray mentioned that he looks forward to sharing the trial data about a year from now. I think one of the times he may have simply said sometime next year, but at least two of the occasions suggested about a year from now. Before anyone jumps to conclusions, Dr. Ray never said that he was referring to top-line data. I 100% interpret that he was referring to presenting full trial data at a meeting such as ESC 2019, which would be in August 2019 about a year from now. Dr. Ray never actually said ESC 2019 though. No one presents just top-line data at a big meeting like that (see this post for examples of top-line data). Instead, one presents full trial data set at these large, prestigious cardiovascular meetings.

My takeaway from this is that there is little chance of 2018 top-line data. In my opinion, we'd be looking at ACC 2019 in March as the conference for full data reveal if top line was expected in 2018. The window for late breaking clinical trial submission closes Dec. 5th, 2018 for the March 2019 ACC meting. It's not impossible for them to meet that, but the window is closing. Also, it is not just ACC or ESC as options. Lots of other conferences in between that could be appropriate venues (examples in this post).

Lastly, in the Q&A there was some good, level headed, back and forth discussion on safety of apabetalone and the fact that the DSMB hasn't highlighted any adverse events yet. It was not a 100% guarantee that apabetalone is safe, but mainly pointing out that no obvious serious adverse events have popped up yet that warranted mentioning by the DSMB. My take on this is that apabetalone is safe enough to warrant completing BETonMACE, but not 100% in the clear yet from a safety perspective. Once the full data set is revealed, apabetalone may or may not be found to elicit increases in some kind of adverse events/disease/health condition/risk factor. That is why clinical trials are run. We must wait and see. 

BearDownAZ