Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

Here's some information on the trials you haven't read about. Brilacidin covid trial will likely be using IV dosing. Following is a copy paste of an earlier post of mine. Easier to grab it than type anew.

For those that aren't aware, keep in mind during research that Brilacidin and PMX-30063 are the same drug. Some issues that were present in PMX-30063 ph2 ABSSSI trial were solved in Brilacidin ph2b ABSSSI trial via lower dosing.

PMX-30063 was tested in clinical trials by PolyMedix.
Brilacidin was tested in clinical trials by Cellceutix that is now Innovation Pharmaceuticals.

ABSSSI trials are the only ones to have been done via IV dosing which is expected to be done in the upcoming Brilacidin covid trial. Other indications in clinical trials with Brilacidin were using various other means of dosing. Swish & spit (OM), enema (UP), and oral tablet (UC)

Aerosol and Intramuscular are untested dosing means for Brilacidin at this point in time.

An officially unnamed company has tested Brilacidin for biofilm use. Many believe it is a part of J&J.

Following are some related bits of data, not all, but, I only had time to grab this without doing a full search:


Population Pharmacokinetic Analyses of Brilacidin Using Data from Healthy Subjects and Patients with Acute Bacterial Skin and Skin Structure Infections

23rd Poster No. P 917 European Congress of Clinical Microbiology and Infectious Diseases, Berlin, Germany. April 27-30, 2013

https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f849d1b631be3d85bd2a5/1480557726468/B00292_brilacidin_ppk_ECCMID13_19apr13-1.pdf

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AAC Accepts, published online ahead of print on 16 June 2014
Antimicrob. Agents Chemother. doi:10.1128/AAC.02955-14
Copyright © 2014, American Society for Microbiology. All Rights Reserved.

https://aac.asm.org/content/aac/early/2014/06/11/AAC.02955-14.full.pdf

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ECCMID 2015 Copenhagen, Denmark 25 – 28 April 2015
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f8286d2b85731b8713a36/1480557192947/A-Randomized-Double-Blind-Study-Comparing-Single-Dose-and-Short-Course-Brilacidin-to-Daptomycin-in-the-Treatment-of-Acute-Bacterial-Skin-Skin-Structure-Infections-ABSSSI1.pdf

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Application of Pharmacokinetic-Pharmacodynamic Models for Brilacidin Dose Selection Support for Patients with Acute Bacterial Skin and Skin Structure Infections

American Society for Microbiology Microbe 2016, Boston, MA. June 16-20, 2016
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f831e579fb3daf479520c/1480557343791/Application-of-Pharmacokinetic-Pharmacodynamic-Models-for-Brilacidin-Dose-Selection-Support-for-Patients-with-Acute-Bacterial-Skin-and-Skin-Structure-Infections-.pdf

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Additionally, two different US Regional Biocontainment labs have done testing of Brialacidin on various tissue samples that have shown effectiveness in the lab.

Grabbed from another post of mine.
bioRxiv PREPRINT that some have been looking for was made available in October.

The US RBL that we anticipated giving us results in September were a bit late. But, we got the pre print in a timely fashion considering the RBL needed the results before they were able to submit the work. The preprint was published October 30, 2020

Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1

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My expectation is for another article to come out from the 2nd lab. Time will tell. Oddly, we may have covid trial results before it hits.








Message in reply to:

You're right, some drugs have not worked well, and there have been clinical failures of IL-6 inhibitors, and so on.

The HGEN drug works upstream from there, targeting the ligand. But the HGEN drug is not an anti-viral. So lenzilumab is being used as a co-therapy along with Gilead's remdesivir in a NIH-sponsored ACTIV5/BET trial, which should be concluding next month, along with the company's internal Phase III trial.

I have a negative bias against remdesivir and Gilead. But regardless, I am glad to see the FDA's IND approval of brilacidin for the Phase II trial. Putting the cart way before the horse here, but I like the idea of HGEN having another source to supply a proven anti-viral.

I think the Phase II trial should conclude quickly, since there have already been 460 patients treated over the course of 8 trials (although I haven't read anything about those trials). This trial will be enrolling 120 patients, and there is already a history that suggests the trial will meet safety and efficacy endpoints, leading to a Phase III trial in the not too distant future.