GREY:ATBPF - Post by User
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MrMugsyon Nov 04, 2022 9:26am
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Post# 35072579
RE:RE:There we are ...
RE:RE:There we are ...TriumphSpitSix wrote: "Just wish we really understood what "significant dose reduction" meant and how it affects Acute and Chronic drug development. Acute is easy to understand but how the dose reduction affects a Chronic plan is anyone's guess."
Not a doctor or chemist but from reading the NR, I believe it is primarily related to an increase in "bioavailability" i.e., how much of the drug actually enters circulation within the body and is then available to reduce pain, inflammation, etc... Presumably, higher bioavailability would allow them to decrease the doses in both Chronic and Acute applications since more of the drug is actually utilized instead of being flushed out of the body.
Hopefully, lowering the dose would address the "elevated LTEs" which doomed the Ph.2 chronic study.
Maybe they combined it with something else or found a way to treat it to make it more soluble? Dunno, just thinking out loud...
Question is ... we hit a hard limit on the lowest possible dose for chronic and that limit complicated what was possible. Have we broken past that limit and can we go lower?
I believe the answer is "yes"
We don't know where this might take us and I'm thinking the details are in the animal studies - a good indication of what's possible with humans (it seems).
Now - let's say that the liver still gets confused at lower dosing ... well ... that's where the start to play with sophisticated regimen controls. That may even include pausing the drug between regimens to reset the liver. So many ways to market - more about how big the market is for us. IMO.
Good Luck !!!!