Re: New Zacks SCR report "Apabetalone: A Potential Alzheimer's Play?"
in response to
by
posted on
Aug 24, 2018 03:33PM
The only "official" update on the event rate that I recall was the statement in the Feb 2018 presentation that stated:
"Projected primary MACE rate still 8.0 per 100 patient years on top of aggressive standard of care (low LDL) = strong unmet need"
When I asked Clayton to clarify he wrote to me:
"To answer your questions, yes the actual events we are observing in the blinded analysis from BETonMACE is close to 8 per 100 patient years as we had planned. As you know this trial remains blinded and therefore, we do not have any access to who is on placebo or who is on drug, so these numbers are derived from all patients."
There was also an unofficial update from Tundup back in June that gave an update on the event rate and patient years.
Both point #1 (placebo event rate) and point #2 (efficacy of apabetalone) from the recent Zacks SCR report are viable explanations for why it is seeming to take longer than expected to accumulate the required MACE events to trigger the SSRA at 75% of planned events (188 events). Also possible that a decision has been made to skip the SSRA.
The predicted placebo event rate may have been correct, or it could be larger than predicted or it could smaller than predicted. The predicted apabetalone effect size may be as predicted at around 30% RRR, or it could be larger, or it could be smaller. There are many combinations of actual placebo event rate and actual apabetalone effect size that could all lead to the same blinded overall event rate number that includes all patients.
BearDownAZ