RE: 26 Weeks Post Full Enrollment Just one minor correction. They are taking the pill twice a day. :)
Yesterday I was looking at the 2003 paper in JAMA on the IVUS analysis on patients infused with the apoAI-milano. You can access it at this link: https://jama.jamanetwork.com/article.aspx?articleid=197579. I was comparing this with what we know from ASSERT (via publication), SUSTAIN (via press release) and ASSURE (via study design).
The JAMA paper is a great example of the kind of data we might see in the IVUS analysis of ASSURE patients treated with RVX-208. Of note, there will be a lot more patients analyzed in ASSURE relative to the apoAI-milano study. Also of note, patients in ASSURE treated with RVX-208 will have received the drug for 6 months, whereas the apoAI-milano study was only 5 week treatment.
If one looks back at the published ASSERT study values (12 weeks of RVX-208 treatment) and also reads the SUSTAIN press release (which doesn't have hard numbers but described the statistical p-values and overall trends), then one can very likley predict that the efficacy of RVX-208 treatment on apoAI, HDL-cholesterol and HDL particle size were not plateauing in their efficacy at the end of the 12 week period. Very likley the prolonged treatment with RVX-208 past 12 weeks in SUSTAIN and ASSURE achieved a very large effect on raising apoAI and HDL-cholesterol.
Long story short, I strongly feel that the likelihood of ASSURE trial giving positive results via IVUS is pretty good. I'll give it an 80-90% positive chance IMO. Why you ask? 1) the magnitude of change in apoAI and HDL-cholesterol elicited by RVX-208; 2) the mechanism of action (new HDL particles, not CETP-inhibitor "garbage bags"); 3) the length of the study (6 months); 4) The power of the study (over 300 patients, most in the treatment group); and 5) The precedence for HDL-infusion giving positve IVUS results.
Basically, I feel that if HDL-raising via RVX-208 can't give positive IVUS results, than no HDL-raising therapy (other than direct, very high dose HDL infusion) can do it.
GLTA.