With the most recent company guidance on BETonMACE timelines and assuming Q1 2019 top-line data holds, when might we see full data presented at a major scientific conference?

We can learn a lot from past cardiovascular outcomes trials (CVOTs) by looking at when their top-line and full data came out and what meeting the full data was presented at. Below are CVOT trials that met their primary outcome. As you can see below, there was anywhere from one to six months in between top-line data announcement and full data presentation at major scientific conference.

A couple trials (CANVASS for canagliflozin SGLT2 inhibitor, ODYSSEY for alirocumab PCSK9 antibody) had no top-line data release, only full data. But another drug in the same class (SGLT2 inhibitor empagliflozin, PCSK9 antibody evolocumab) had released their CVOT results 1-2 years prior. BETonMACE is first in class so I fully expect it to release top-line separate from full data. 

EMPA-REG OUTCOMES (Jardiance/empagliflozin SGLT2 inhibitor): August 2015 top-line; full data EASD September 2015.

CANVASS (Invokana/canagliflozin SGLT2 inhibitor): No top-line; full data ADA June 2017. 

CANTOS (canakinumab anti-IL1B antibody): Top-line June 2017; full data ESC August 2017.

FOURIER (Repatha/evolocumab PCSK9 antibody): Top-line Feb 2017; full data ACC March 2017.

ODYSSEY (Praluent/alirocumab PCSK9 antibody): No top-line; full ACC March 2018. 

COMPASS (Xarelto/rivaroxaban anticoagulant): Top-line Feb 2017; full data ESC August 2017.

LEADER (Victoza/liraglutide GLP1-R agonist): Top-line March 2016; full data ADA June 2016.

REVEAL (anacetrapib CETP inhibitor): Top-line June 2017; full data ESC August 2017.

SUSTAIN-6 (semaglutide GLP1-R agonist): Top-line April 2016; full data EASD September 2016.

So if top-line data for BETonMACE is expected Q1 2019, what scientific meeting(s) might be in play for presented full data? Keep in mind that different sub-studies may be presented at different meetings. For example, MACE data at cardio conference; renal sub-study at renal conference; cognition sub-study at neuro/Alzheimer's conference.

1) The earliest possibility is the American College of Cardiology (ACC) meeting, March 16-18, 2019. The Late-Breaking Clinical Trial Submissions are open Wednesday, Oct. 24 – Wednesday, Dec. 5, 2018. The FOURIER trial, which was a much larger CVOT, announced top-line Feb 2017 and presented at the March 2017 ACC meeting. EMPA-REG OUTCOME only had a month in between top-line and full data at EASD in 2015. So there is precedence for quick turnaround. Resverlogix may anticipate trial ending and submit abstract by the Dec 5 deadline. Since BETonMACE is a relatively small CVOT with only ~2400 patients and ~250 MACE events, the adjudication and wrap up shouldn't take as long as the larger CVOT trials.

2) Next up are a slate of May/June 2019 meetings: Vascular Discovery May 2019, European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) June 2019, American Diabetes Association (ADA) June 2019. These would all be well outside of the Q1 2019 expected top-line BETonMACE announcement. 

3) Next would be European Society for Cardiology (ESC) in August 2019 and European Association for the Study of Diabetes (EASD) in September 2019. 

4) Last, we have the November 2019 American Heart Association (AHA) and November 2019 American Society for Nephrology (ASN) Kidney Week.

While ACC March 2019 may be possible, Resverlogix has been the most active at the August ESC meetings with all of those apabetalone/epigenetics symposiums. The COMPASS and SUSTAIN-6 trials had 5-6 month period in between top-line and full data at ESC and EASD, respectively. Plus, Don's birthday is in late August too I think. Kausik Ray did make a comment during the August 2018 ESC symposium that he looks forward to hopefully presenting the BETonMACE data at next year's ESC meeting.

Time will tell. First things first. End of dosing and hopefully positive top-line data! Note: I'm not as familiar with the Alzheimer's meeting schedules and which are most common for clinical trial data, so I left those conferences off of the list.

Goodnight all,

BearDownAZ