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Posted On: 01/10/2020 9:39:24 PM
Post# of 72446
I had a request to post the following from an earlier post.
The current trial is on healthy volunteers so we will have to wait until the latter trials on UC patients to see how effective it is.
That being said, I am optimistic about our chances of demonstrating efficacy in the later trials. Assuming the BDD trial shows Brilacidin is delivered to the colon at an expected dosage with no significant side effects, IPIX has a chance to confirm efficacy of the oral dosage that was seen in the Brilacidin enema in the stage 2 POC trial of the Brilacidin for Ulcerative Proctitis.
With the safety profile demonstrated in the stage 2 FDA trial for ABSSSI and the lack of systemic absorption it would be very surprising if we see any significant systemic side effects
http://www.ipharminc.com/press-release/2017/1...d-outcomes
The efficacy of Brilacidin in the Stage 2 POC trial was reported at the Crohns and Colitis Foundation meeting in 2018 and is summarized on the IPIX poster. Findings include:
1.excellent safety profile
2.excellent efficacy after 42 days with 3 dosage cohorts
- >50% complete remission
- NO rectal bleeding in 16/17 patients
- Colonoscopy confirmation of clinical responses
- improved quality of life in 16/17
https://static1.squarespace.com/static/571535...nal%29.pdf
IPIX's partnering with AS for Brilacidin for UP provides pharma confirmation of the excellent reported results.
In addition there is a large body of medical literature suggesting IBD is associated with diminished definsin secretion in the GI system. The most likely mechanism of action of Brilacin is to replace the GI defensins.
https://scholar.google.com/scholar?q=inflamma...i=scholart
Plus, the market for UC and IBD is enormous affecting hundreds of thousands in the USA and millions worldwide. The current treatments are often inadequate and dangerous. The new biologic therapies often have black box FDA warnings for life threatening infectios and malignancies.
GLTA Farrell
The current trial is on healthy volunteers so we will have to wait until the latter trials on UC patients to see how effective it is.
That being said, I am optimistic about our chances of demonstrating efficacy in the later trials. Assuming the BDD trial shows Brilacidin is delivered to the colon at an expected dosage with no significant side effects, IPIX has a chance to confirm efficacy of the oral dosage that was seen in the Brilacidin enema in the stage 2 POC trial of the Brilacidin for Ulcerative Proctitis.
With the safety profile demonstrated in the stage 2 FDA trial for ABSSSI and the lack of systemic absorption it would be very surprising if we see any significant systemic side effects
http://www.ipharminc.com/press-release/2017/1...d-outcomes
The efficacy of Brilacidin in the Stage 2 POC trial was reported at the Crohns and Colitis Foundation meeting in 2018 and is summarized on the IPIX poster. Findings include:
1.excellent safety profile
2.excellent efficacy after 42 days with 3 dosage cohorts
- >50% complete remission
- NO rectal bleeding in 16/17 patients
- Colonoscopy confirmation of clinical responses
- improved quality of life in 16/17
https://static1.squarespace.com/static/571535...nal%29.pdf
IPIX's partnering with AS for Brilacidin for UP provides pharma confirmation of the excellent reported results.
In addition there is a large body of medical literature suggesting IBD is associated with diminished definsin secretion in the GI system. The most likely mechanism of action of Brilacin is to replace the GI defensins.
https://scholar.google.com/scholar?q=inflamma...i=scholart
Plus, the market for UC and IBD is enormous affecting hundreds of thousands in the USA and millions worldwide. The current treatments are often inadequate and dangerous. The new biologic therapies often have black box FDA warnings for life threatening infectios and malignancies.
GLTA Farrell
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