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Posted On: 09/16/2019 9:45:23 AM
Post# of 72440
So, the pill formulation with its time-release coating has been made and clinical trials start in December. This is good news, company is moving forward with what could be a blockbuster.
In case people are wondering -- having the technology to deliver the Brilacidin BEYOND the stomach -- not having a capsule dissolve in the stomach where stomach acid might degrade it, and it might not make it intact into the colon -- is very important.
By having it released where it is needed, the colon, and not in the stomach, there is much less chance of significant systemic absorption. (It's always better to have a drug targeted for the area it's needed rather than affecting the whole body.) Brilacidin is going to wipe out some of the bacteria in the gut, so it's better that it wipes out the bacteria in one area but doesn't do anything significant to the rest of the body.
You may recall that the Brilacidin enema-version for UP had no significant systemic absorption. We'll hope that similarly this pill does not have it -- but even if there is some systemic effect, I can't imagine that it would be a problem for FDA approval, given the side effects like cancer and death that some of the biologics have, and yet they are commonly prescribed.
In case people are wondering -- having the technology to deliver the Brilacidin BEYOND the stomach -- not having a capsule dissolve in the stomach where stomach acid might degrade it, and it might not make it intact into the colon -- is very important.
By having it released where it is needed, the colon, and not in the stomach, there is much less chance of significant systemic absorption. (It's always better to have a drug targeted for the area it's needed rather than affecting the whole body.) Brilacidin is going to wipe out some of the bacteria in the gut, so it's better that it wipes out the bacteria in one area but doesn't do anything significant to the rest of the body.
You may recall that the Brilacidin enema-version for UP had no significant systemic absorption. We'll hope that similarly this pill does not have it -- but even if there is some systemic effect, I can't imagine that it would be a problem for FDA approval, given the side effects like cancer and death that some of the biologics have, and yet they are commonly prescribed.
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