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Posted On: 04/04/2019 8:09:56 PM
Post# of 72451
After the announcement of the excellent results with the gastric acid testing, IPIX announced they were going to begin testing on normal volunteers. Presumably this would be to test expected parameters like drug levels in the colon and small intestines as well as serum levels. This testing should be straight forward and relatively inexpensive. It would precede a stage 2 clinical trial. IPIX has already secured manufacturing of Brilacidin; so it is very possible these studies are underway
The idea is if, as the gastric acid study suggests, Brilacidin passes through the acidic stomach unchanged it is already at one of its target site, the small intestines with the colon close behind {pardon the pun}.
The potential market and profitability dwarfs OM.
Below is a post I made on IHUB about the same point.
oday,s PR was a better explaination but the highlights were outlined in the last PR on 1/14.
http://www.ipharminc.com/press-release/2019/1...el-disease
See my summary from 1/15
GLTA, Farrell
IMO IPIX will do the nuts and bolts clinical testing out of the way with the oral Brilacidin solution while they wait for the delivery of the more sophisticated oral drug for the next FDA study.
As with Budesonide the more sophisticated pill would provide more predictable drug release and with the multilayered technology may be able to target different areas of the intestines. For example the proximal small intestine can be involved with Crohn's disease would be targeted for earlier drug release while the distal colon, as in Ulcerative Proctitis, might respond better with a later drug release.
We will have to wait and see,
Farrell
"Results ...suggesting that a simple formulation of Brilacidin likely would not be subject to rapid breakdown once in the stomach. This finding should enable initial clinical testing with a simple formulation of the drug candidate delivered to the gut while a more elegant, tailored oral dosage form of Brilacidin is developed and refined, in parallel. The end goal would be to release Brilacidin selectively in the GI tract via targeted delivery technology."
The idea is if, as the gastric acid study suggests, Brilacidin passes through the acidic stomach unchanged it is already at one of its target site, the small intestines with the colon close behind {pardon the pun}.
The potential market and profitability dwarfs OM.
Below is a post I made on IHUB about the same point.
oday,s PR was a better explaination but the highlights were outlined in the last PR on 1/14.
http://www.ipharminc.com/press-release/2019/1...el-disease
See my summary from 1/15
GLTA, Farrell
IMO IPIX will do the nuts and bolts clinical testing out of the way with the oral Brilacidin solution while they wait for the delivery of the more sophisticated oral drug for the next FDA study.
As with Budesonide the more sophisticated pill would provide more predictable drug release and with the multilayered technology may be able to target different areas of the intestines. For example the proximal small intestine can be involved with Crohn's disease would be targeted for earlier drug release while the distal colon, as in Ulcerative Proctitis, might respond better with a later drug release.
We will have to wait and see,
Farrell
"Results ...suggesting that a simple formulation of Brilacidin likely would not be subject to rapid breakdown once in the stomach. This finding should enable initial clinical testing with a simple formulation of the drug candidate delivered to the gut while a more elegant, tailored oral dosage form of Brilacidin is developed and refined, in parallel. The end goal would be to release Brilacidin selectively in the GI tract via targeted delivery technology."
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