Below are a couple of paragraphs from Tundup’s June 2018 post.Overall the full text of the post does not seem to suggest anything that would lead anyone to believe that the primary endpoint would or would not be met.Further, we’re all still waiting on the details on Nov 16th because just a statement that the primary endpoint was not met, while surely disappointing, doesn’t really tell you much.The first paragraph below pretty much confirms the safety aspect which DM also confirmed in the webcast.
Safety is fine – have now had 24 patients on Apabetalone for 2.5 yrs (1st patient Nov 2015). Interestingly the drug only really works when you are sick, it doesn’t really have much of an effect on healthy subjects. This is why Assure trial failed because 25% of patients weren’t that sick and had high levels of HDL.
Blinded data is also pointing in the right direction for the other end points – eGFR data “looks stunning, seeing amazing increases, unheard of”, cognitive improvement (MoCA test) data also encouraging (looking for >1.5 units improvement; anything <18 is considered Alzheimers).
The excerpt above on eGFR and MoCA data is of course more demonstratively positive although, as tundup correctly pointed out, how could they know that given that the trial is blinded.But, for what it’s worth I’m hopeful that the above comments bear fruit and I’m also encouraged by BDZ’s positive outlook on both the CKD and cognition sub studies.Having said that I’m under no illusions that things could just as easily go the other way.
Anyway, I think it’s time for a win here because the alternative would, well, really suck.