Re: Slides from Resverlogix Corporate Update 6/13/16
in response to
by
posted on
Jun 13, 2016 03:54PM
"I missed this before, but Slide 22 referred to BETonRENAL as a Phase 2 trial, so it must still be RVX-208/apabetalone or else they'd need to start Phase 1 with a new molecule."
OK, well I am reversing course again. Slide 21 indicated
"Meeting 2: Type B meeting, pre IND for our new renal program; Review of top line PK data. The PK data will be derived from a new clinical program being launched this week in New Zealand. First patient dosing will be news released upon completion."
I don't think they would need a new IND for RVX-208/apabetalone in renal since that molecule is already in Phase 3. And pharmacokinetic (PK) studies are typically Phase 1 studies. This type a language makes me think that this is for a new molecule. However, if they know that RVX-208/apabetalone was eliciting favorable results for alkaline phosphatase and estimated Glomerular Filtration Rate, then why switch to a new molecule. Perhaps BETonRENAL Phase 2 will be the "full blown dialysis trial in 2017" that Don referred to today, but that the imminent New Zealand trial is going to be a Phase 1. I look forward to the upcoming news release for some clarification here.
BearDownAZ