...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Re: Placebo rate for 2 sub groups
2
Mar 12, 2019 08:40AM

Cabel,

I think a similar line of questioning is going on in this other thread "Question about Phase 2" right  now too. I'll just chime in on both threads here.

Yes, there are both placebo and apabetalone groups in the CKD and Cognition Sub-Studies. And yes, that data is blinded. You can get a better idea of the sub-study trial designs in the posters linked below:

2018 Alzheimer's Association International Conference (AAIC)
Apabetalone (An Epigenetic BET-Inhibitor Small Molecule): A Substudy Evaluating Effects on Cognition in Diabetes Patients with Cardiovascular Disease.

https://www.resverlogix.com/upload/media_element/126/624b16e67446/2018-05-08-aaic-poster-2018-cognition-subgroup.pdf

2018 European Renal Association European Dialysis and Transplant Association (ERA-EDTA) Congress
BETonMACE Chronic Kidney Disease Sub-Study: Effects of the Selective BET-Inhibitor Apabetalone on Kidney Function and MACE in Post-ACS Patients with Diabetes and Estimated Glomerular Filtration Rate Below 60. 

https://www.resverlogix.com/upload/media_element/125/20402f6425eb/2018-05-02-era-edta-poster-2018-kidney-disease-subgroup.pdf

Cabel asked "Is it possible that the company has a good idea that the dementia and kidney sub groups are performing well,...?"

Similar to iconoclast's and Topcoin's comments in the other thread, I think that Resverlogix is receiving blinded data on several measurements, inlcuding those related to the cardiovascular study, but also the MoCA scores for the cognition sub-study and the ALP and eGFR values for the CKD sub-study. I recall in one of the AGM or Corporate Update transcripts reading something about management seeing an impressive change from baseline in the blinded eGFR data; however, I don't recall the exact context or statement or presentation. So maybe someone else can chime in. But if true that blinded data is showing a remarkable change in eGFR from baseline, then this would be consistent with the post-hoc analysis of the Phase 2 trials that showed apabetalone-treated patients experienced a significant improvement in eGFR. Since the BETonMACE eGFR data is blinded, this data would be an average placebo and apabetalone patients combined. For management to state that they see an change in the average eGFR may indicate that the apabetalone-mediated improvement in eGFR is very large in order to change the average that also includes patients on placebo that presumably don't experience eGFR improvements. However, it could also mean that both placebo and apabetalone groups are improving. I'd like to believe it's because of apabetalone though! 

There was an interesting sentence in the abstract for the upcoming ACC presentation that states "MoCA score change from preliminary blinded data shows a standard deviation of 3.2 points and a sample size of 54 subjects per arm to provide a 90% power to detect a mean between-group difference of 2 points at p<0.05." However, this was worded a little differently for the abstract of the upcoming AD/PD meeting and stated "MoCA score change from historical data shows a standard deviation of 3.2 points predicting a necessary sample size of 54 subjects per arm to provide a 90% power to detect a mean between-group difference of 2 points at p<0.05." I'm not quite sure how to interpret that. But it could be similar to what I described for eGFR above in that this MoCA change is on the blinded total group that includes placebo and apabetalone patients; the change from baseline could be entirely from apabetalone. Or it could be both groups experiencing benefit. I'd like to think it is from apabetalone!

BearDownAZ

 

 

Share
New Message
Please login to post a reply