Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"there was no systemic absorption of brilacidin"

I doubt that's true - it would make brilacidin unique among small molecules, and I doubt IPIX has the expertise or wherewithal to have developed and validated an assay that would confirm that categorical statement. Happy to see the data if it exists, though.

I sure don't have the data, but somebody might. A few excerpts from a press release touch on the issue:

February 13, 2020
Innovation Pharmaceuticals Phase 1 Trial of Brilacidin for Ulcerative Colitis Meets Primary Endpoints; Positive Topline Results of Oral Brilacidin

"Serial blood samples were collected through 24 hours post-dose to assess absorption of oral Brilacidin from the colon. Blood level analysis, using a sensitive limit of quantitation in plasma of 1 ng/mL, demonstrated no quantifiable Brilacidin concentrations at any timepoint across treatment cohorts and shows containment of Brilacidin within the target location. (Confirmatory repeat plasma concentration analyses are ongoing to verify this finding).

Given Brilacidin has shown clinical efficacy with limited absorption in other clinical trials, in Ulcerative Proctitis/Ulcerative Proctosigmoiditis and Oral Mucositis, these results suggest oral Brilacidin for IBD might be safely dosed at even higher levels of drug via targeted release tablet."
http://www.ipharminc.com/press-release/2020/2/13/innovation-pharmaceuticals-phase-1-trial-of-brilacidin-for-ulcerative-colitis-meets-primary-endpoints-positive-topline-results-of-oral-brilacidin


Other mentions:
"That Brilacidin is showing signs of mucosal healing, as well as having a favorable pharmacokinetic profile (low systemic absorption), speaks to its potential as a novel treatment for various types of Inflammatory Bowel Disease (IBD)."
http://www.ipharminc.com/new-blog/2017/2/2/endoscopic-remission-in-the-treatment-of-ulcerative-colitis?rq=absor

"Brilacidin’s low level of systemic absorption when topically administered (as revealed in its use in Ulcerative Proctitis/Ulcerative Proctosigmoiditis and Oral Mucositis, currently in mid-stage clinical trials), while remaining efficacious, further reinforces its therapeutic potential in treating skin diseases."
http://www.ipharminc.com/new-blog/2017/6/5/brilacidins-potential-application-in-dermatology?rq=absor

"These data suggest that other inflammatory conditions may, likewise, be treated locally and efficaciously with Brilacidin without significant systemic absorption, better ensuring a safe and well-tolerated therapeutic profile. Given Brilacidin’s low level of systemic exposure, moderate-to-high dosing of the drug by topical application to the skin might also be supported in treating various dermatology disorders and conditions."
http://www.ipharminc.com/press-release/2016/10/27/cellceutix-novel-anti-inflammatory-phase-2-drug-candidate-brilacidin-builds-momentum-across-multiple-clinical-indications?rq=absor


There's more but I think that may be enough.
I'm pretty sure that the skin, colon and mouth are composed of very different tissue structures, but others know better.
And "limited", "low" and "without significant" levels of absorption are relative terms.
But the terms that the Company HASN'T used when it comes to the systemic absorption of Brilacidin are "no" and "none".
Those are the terms that I would expect them to use if the data supported them.

It seems safe to conclude that there is SOME systemic absorption of brilacidin.


You expressed this belief and it makes sense to me:
"In the world of post-marketing surveillance, even one SAE against a denominator of maybe millions is regarded as a signal that needs to be explored, reported and if necessary results in labelling changes up to and including new contraindications or even withdrawal."

But as to the specifics of this issue:
What other SAE's would you expect to occur as a result of a swish and spit process that causes an infection at a catheter site in a patients arm? Would a trial continue if the swish and spit material caused a new infection in the mouth itself, where an infection already exists and no systemic absorption would be required? Wouldn't you expect that a material that causes an infection in the arm after system travel also create a very apparent problem in the mouth...in all patients given that they have mouth tissue "openings"?