Re: I think one major reason that,
in response to
by
posted on
Nov 02, 2019 09:47AM
"They should have compared Crestor vs Crestor plus rvx. And Lipitor vs Lipitor plus RVX as separate end points!"
OK. I think I see your point.
1) They had good idea that apabetalone worked differently with crestor vs. lipitor from Phase 2 ASSURE post-hoc
2) Resverlogix did not have any evidence of differential effect of apabetalone with the other non-statin standard of care drugs
3) As pointed out, Resverlogix wanted to originally only run BETonMACE with crestor, but ended up doing both crestor and lipitor in the final design
4) Crestor (rosuvastatin) and Lipitor (atorvastatin) are listed as separate interventions/treatments on ClinicalTrials.gov "Drug: RVX000222, Drug: Placebo (for RVX000222), Drug: atorvastatin, Drug: rosuvastatin."
5) Despite #4 above, the primary endpoint of BETonMACE does not explicitly state that the two statins would be compared separately (Crestor/placebo vs Crestor/apabetalone separate from Lipitor/placebo vs Lipitor/apabetalone:
6) Despite #4 and #5, Resverlogix has planned from the beginning to look at the two statin groups separately in a pre-specified subgroup comparison of the primary endpoint. Those pre-specified sub-group comparisons for the primary endpoint have been listed in various corporate/science presentations since BETonMACE began. Additionally, I asked IR over 4 years ago "Is there a pre-defined comparison between those patients on rosuvastatin vs. atorvastatin, or will that comparison be a post-hoc analysis after BETonMACE has ended?" and received the reply "yes the rosuvastatin/atorvastatin will be a pre-specified analysis."
7) Despite #6 above, the published BETonMACE rationale and design paper as well as the BETonMACE posters have no mention of these pre-specified sub-group comparisons for the primary endpoint. And there was no mention of this during the main corporate update this week (RVXOT indicated there was mention during the Q&A). And there was no mention in the top-line data news release of further pre-specified sub-group comparisons.
So in summary, IF they would have had set up a primary endpoint to look at the two statin group separately (i.e. two primary endpoint read outs) instead of having one primary endpoint that combined the statins, then we would have received a lot more information in the top-line data read out. The top-line data read out would have told us whether apabetalone had differential benefit with one statin vs. the other. However, the way the trial was actually set up, we will need to wait for them to announce the pre-specified subgroup analysis of the primary endpoint to get this information. Hopefully all of this will be revealed by Nov 18th.
Is that a good summary of your criticism/frustration Kipk?
BDAZ