Coming up November 10-12 is the annual American Heart Association conference at which Resverlogix has a couple of presentations. I think this may be the first poster to present the baseline BETonMACE data (renal and cognitive sub population baseline data were presented earlier this year). I think they showed the to-date baseline data in a power point presentation at an investor conference earlier this year, but this will be the first presentation at a scientific meeting.

Presentation #1 November 11: "Cardiovascular Evaluation of the Selective BET Inhibitor, Apabetalone, in ACS Patients With Diabetes: Baseline Characteristics of the BETonMACE CV Outcomes Study." Abstract currently embargoed.

Presentation #1 November 12: "Apabetalone (RVX-208) Suppresses Expression of Key Vascular Inflammation Markers in Monocytes, Endothelial Cells and LPS-Challenged Mouse Liver and Monocyte Adhesiveness to Activated Endothelial Cells." Abstract currently embargoed.

Another trial to keep an eye on at AHA is the Cardiovascular Inflammation Reduction Trial (CIRT), in which patients with type-2 diabetes or metabolic syndrome are being given low-dose methotrexate to investigate whether this anti-inflammatory approach will reduce 3-point MACE (cardiovascular death, stroke, myocardial infarction). These patients are required to have a documented myocardial infarction in past five years and must be clinically stable for at least 60 days prior to screening. These CIRT patients are not as high-risk as those in BETonMACE. CIRT was halted early back in May of this year and the investigators are hoping to report full data at AHA.

CIRT is somewhat of a sister study of CANTOS, both lead by Dr. Paul Ridker to directly investigate the inflammation hypothesis in cardiovascular disease. Recall, in the CANTOS trial, Canakinumab (anti-interleukin-1beta antibody) was found to reduce pooled 3-point MACE by 12-15% (depending upon dose). Unlike the expensive, injectable antibody used in CANTOS, CIRT uses low-dose methotrexate as a cheap, generic therapy given orally as a once-weekly agent.  

If CIRT is successful, I am not sure how much use it would get in the clinic. However, this article ended by stating "If low-dose methotrexate reduces cardiovascular events, CIRT would both support the inflammatory hypothesis of atherothrombosis and serve as a catalyst for the development of novel therapeutic agents focused specifically on vascular inflammation." This makes it sound like CIRT is more of a proof of principle for future inflammation targeted therapies. Did I mention that apabetalone has a strong anti-inflammatory component to its mechansim of action?

Bfw commented before in this thread "Sounds like futility. Ending a study like this early would not be prudent if there was a benefit....unless it was massive. Reading between the lines, I don’t see that."

Maybe, maybe not. We will see. At this time, we don't know if CIRT was halted for efficacy or for futility. 

Sumpup commented "This is an arcahic antimetabolite (folate antagonist) immunosuppressant that has been used for an array of conditions for over 70 years and is dirt cheap. Side effect profile can be nasty. Supprised by this. I can only imagine the cost effectiveness is a driving force behind this."

I don't have a great background on the safety/side effects of low-dose methotrexate. Anyone care to chime in on this?

Here are a few articles on the background for CIRT and CANTOS:

Closing the Loop on Inflammation and Atherothrombosis: Why Perform the Cirt and Cantos Trials?

Rationale and Design of the Cardiovascular Inflammation Reduction Trial (CIRT): A Test of the Inflammatory Hypothesis of Atherothrombosis

Systematic Review and Meta-analysis of Methotrexate Use and Risk of Cardiovascular Disease