"It is extremely well tolerated by patients, with safety data now exceeding 2700 patient years."
I went back and calculated the number of patient years from past Phase 1 and 2 trials. ASSERT had 225 apabetalone patients treated for 12 weeks (52 patient years); SUSTAIN had 88 apabetalone patients treated for 24 weeks (41 patient years); ASSURE had 243 apabetalone patients treated for 26 weeks (122 patient years). The earlier Phase 1/2 trial on ClinicalTrials.gov, Phase 2 Pre-diabetes trials, and Phase 1 CKD trial in New Zealand were short and small trials and I estimate only contribute at most 5 collective patient years. So by my estimates that is only 220 patient years for past trials.
The paper was received April 2, 2019 and accepted on June 11, 2019. Resverlogix announced on April 18th that they would begin the last study visits at which dosing would end and it sounds like from the June 12th news release that all last study visits were completed. So by my rough calculculations, at most about 236 patient years accumulated in BETonMACE during the 71 days between 4/2/19 and 6/12/19, assuming 1212.5 patients (half of 2425 full enrollment) on apabetalone.
So based on the above, the low end estimate of patient years is 2700 minus 220, or apabetalone 2480 patient years. The high end estimate is (2700+236) minus 220, or apabetalone 2716 patient years. This high end does not account for patient dropouts/dicontinuations that would lower the 1212.5 patient number and does not account for patients completing last study visits and ending dosing prior to June 12th.
"Bear, if the dosed patients are now at 2200 patient years, won't that imply that the Phase 3 trial is now at 4400 patient years at least? I assume the 2200 patient years was of submission of the article to the journal. So that could be 3 months back (I am just guessing here) which would imply even more patient years."
Since half patients are placebo and half are apabetalone, yes one should be able to double the apabetalone patient year estimate to obtain the total trial patient year estimate. With my revisions above, this BETonMACE total patient years would be 4960 to 5432 total BETonMACE patient years.
Please check my math and do your own due diligence.
BearDownAZ
