Re: ESC Wrap Up for Sunday Sept 1....
in response to
by
posted on
Sep 02, 2019 03:47PM
"I do find it a bit odd that given all the excitement that panel displays that there is absolutely no mention of epigenetic’s or the phase 3 trial. I can understand that they don’t want to mention RVX per se but you would think something?"
Clinical trial success is the currency of conference attention and excitement. Recall that most believe there is no proof of the HDL hypothesis, the only successful major apabetalone trials were with HDL/apo-AI modulation, the most recent major apabetalone trial (Phase 2 ASSURE) failed, and apabetalone has proven itself in zero Phase 3 trials. They'll pay attention to apabetalone if and when it has proven itself. Phase 2 post-hocs of 5-point MACE and all of the other analysis of Phase 2 data is nice. But meeting pre-specified endpoints of a major Phase 3 trial is what is needed to get attention. Most drugs (SGLT2 inhibitors, GLP-1R agonists, PCSK9 antibodies, Inclisiran, bempedoic acid, Vascepa, etc) follow the path of first proving themselves in Phase 3 with modifiable endpoints (Glucose, Triglyceride, LDL-C) before conducting Phase 3 cardiovascular outcomes trial. By the time CVOT is completed, the drug is usually already FDA/EMA approved for modifying the respective risk factor. If and when the CVOT succeeds, the label can be modified to include for cardiovascular indication. Resverlogix/apabetalone have not followed that traditional track. Conducting a CVOT with a drug that isn't already approved for an already established risk factor is not the norm. Therefore, BETonMACE will be the trial that could out them on the map.
BearDownAZ