Replies to post #301608 on Innovation Pharmaceuticals Inc (IPIX)

[GreenBioAnalyst]

Do we know the total headcount of patients that had taken Bril altogether? That's just safety profile of drug as to why they'll be testing Bril Phase II patients in CV19 patients?

Bril could be worth as much as a 10b tag price since its the flagship. Cv19 trials will help us get to $3b+ valuation. Maybe $5b cash upfront plus up to $5b in CVR? Ipix can throw in K for free!

[MinnieM]

An Independent Evaluation of a Novel Peptide Mimetic, Brilacidin (PMX30063), for Ocular Anti-Infective

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4742993/

J Ocul Pharmacol Ther. 2016 Jan 1; 32(1): 23–27. doi: 10.1089/jop.2015.0098
PMCID: PMC4742993 PMID: 26501484

[DaubersUP]

Great Post!

[TradingPro]

This should be stickied! Great post!

[HolesInMyPockitz]

Excellent summary that I will be sharing with others. Thank you!

[loanranger]

"Brilacidin for ABSSSI is ph3 ready. Ph2 was dosed via IV in hundreds of patients.
Brilacidin for OM is ph3 ready. Ph2 was dosed via swish and spit."

Is "finished Phase 2" your operating Phase 3 definition?
The Company published a Table in the latest 10Q that described B-ABSSSI as "Phase 2(completed)" and B-OM as "Phase 2 Study (completed) Phase 3 in preparation".

"Ph3 ready" doesn't seem to be a phrase that the Company itself uses. It isn't in the latest 10-Q or 10-K, leaving me to wonder whether the FDA may not like the phrase or agree with its use under these circumstances. Or I suppose the Company just might not be as comfortable with it as you seem to be. It does SOUND meaningful.

The specifics per the 10-Q:
Re B-ABSSSI:
The Company submitted a Special Protocol Assessment (SPA) request including a proposed study design to the FDA in 2016. It then "received from the FDA comments and considerations for incorporation into our study design".
The Company never responded to the FDA comments.

Re B-OM:
Per the 10-Q the Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting (in December of 2018) concerning the continuing development of Brilacidin oral rinse to decrease the incidence of severe OM in HNC patients receiving chemoradiation. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on severe OM when cisplatin, the preferred chemotherapy regimen in HNC care, is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen.
The phrase "oral mucositis" appears a total of three(3) times in the latest 10-Q. The About Innovation Pharmaceuticals section of the latest press release says:
"A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources."

[steelyeye]

A wonderful summary for new eyes. Link back to Karin's post. This will give you an overview of the progress and significance of Brilacidin.

[LilyGDog]

Out of the park post and a must read! Thank you,

Go Leo & IPIX!

Brilacidin items of importance that are basic to know for those without medical training.

Brilacidin has passed safety benchmarks in multiple clinical trials and, is currently being tested as a covid therapeutic in two US RBL’s.

Brilacidin for ABSSSI is ph3 ready. Ph2 was dosed via IV in hundreds of patients.

Brilacidin for OM is ph3 ready. Ph2 was dosed via swish and spit.

Brilacidin for UP ph 2 POC trial was dosed with water enema. Results good enough that Alfasigma licensed Brilacidin for UP dosing with foam, enema, or gel.

Brilacidin for UC ph 1 was dosed with Oralogic tablet.

*****

http://www.ipharminc.com/press-release/2020/5/26/innovation-pharmaceuticals-receives-data-from-public-health-research-institute-showing-brilacidin-inhibits-sars-cov-2-covid-19-in-a-human-cell-line
Quote:
· Brilacidin showed a dose-dependent inhibitory response in a human kidney cell line expressing hACE2
· Data supports Brilacidin’s potential to prevent SARS-CoV-2 binding to the hACE2 receptor, the method by which the novel coronavirus gains entry in human cells

*****

https://www.globenewswire.com/news-release/2020/06/11/2046799/0/en/Innovation-Pharmaceuticals-Collaborating-with-Regional-Biocontainment-Lab-on-Grant-Application-to-Research-Brilacidin-as-a-Pan-Coronavirus-Therapeutic.html
Quote:
a clinical stage biopharmaceutical company, announces today the Company and researchers at a U.S. Regional Biocontainment Laboratory (RBL) are collaborating on a federal grant application to be submitted this week.

This is likely to have been submitted on Friday the 12th and, that is the date I’ll be using for my purposes.
Quote:
The proposed research aims to evaluate Brilacidin as a potential pan-coronavirus therapeutic, for treating SARS-CoV-2, SARS-CoV-1 and MERS-CoV, including extending the current in vitro testing of Brilacidin to in vivo testing.

With grant approval they will likely move into in vivo testing asap. This means animals or clinical trials. Given the global concern, this is when I expect human trials to start using IV dosing.

The question remains as to whether or not this grant is approved. This will be helped by the fact testing is being conducted by US RBL's and not internal company testing.

Again, due to global concern and the fact that Brilacidin has been safely administered to hundreds of humans in clinical trials, I’m expecting it to be approved. I also expect expedited approval due the global concern.

Probability is finally on our side as shareholders due to the seriousness and intensity of the global concern surrounding covid. And, I don’t believe Leo would make false covid claims with the SEC watching this arena closely.

SEC Charges Companies and CEO for Misleading COVID-19 Claims
https://www.sec.gov/news/press-release/2020-111
Quote:
We are actively monitoring the markets to detect potential fraudsters who seek to use the COVID-19 crisis as a basis for investment scams,” said Stephanie Avakian, Co-Director of the SEC’s Division of Enforcement.

Good luck to all…

[chrismiss_everyday]

Thanks for the summary KarinCA!

Just a matter of time...

[attilathehunt]

Don't you think the trials will be slow to start due to C-19?

If we are heading to another lockdown, I believe trials of all types will severely slowdown or stop altogether. Many trials were impacted already so to start them back up appears to be a long uphill drive.

Thoughts?

[NotRichYet2]

Would personally love to see a P3 stated for Brilacidin

[1iftrue]

Got it Karin. Sorry for the odd maybe confusing text about our ihub forgetfulness I had. ??