Shouldn't Prana have PR'd something about the two new Phase 1 trials?
Am I off base? This is a time when it is crucial that this company keeps the market informed about updates, changes, progress etc. Not addressing these two new trials has only raised more questions for me. This is a terrible time to give shareholders addition items to question or draw their own conclusions about.
Right now I've drawn three conclusions; 1. This will only lengthen the time before a Phase III HD trial can begin, along with all the other benefits that go along with starting that trial. 2. The need for these new trials stems from some "hindsight" realization after the failures of the Imagine trial. 3. Kempler is demonstrating more poor leadership abilities by not taking this opportunity to issue a progress update.
What I think here is that PBT2 needs to get accepted by FDA and so the metabolism in a human body needs to be studied. The metabolism can be different in some people than in most of us.
One important enzyme in pharmacokinetics of drugs is CYP1A2. Measuring CYP1A2 activity in vivo can be an important tool to identify the factors that influence variability in drug pharmacokinetics and inform dose selection. Caffeine is the only currently accepted probe to conduct in vivo phenotyping of CYP1A2 .
So clearly Prana is now closer to send it's papers to FDA. I still think that ReachHD results could be enough for efficacy but now these pharmacokinetic studies are missing, but not for long.
I have not seen another company do pharmacokinetics trials inbetween phase 2 and 3 but my biotech experience is somewhat limited. It doesn't seem to be that common at all in trial form. Is it possible to figure this out in a lab in some instances? The information these new trials will provide seems to be something Prana would want to know before even doing Phase II trials.