Replies to post #329384 on Innovation Pharmaceuticals Inc (IPIX)

[williamssc]

RBL covid work has culminated to this juncture. The cake is in the oven.

[loanranger]

"Name the CDMO"

That should be a simple request...it's a requirement for an IND application...but we only have an indirect answer to it and it's from the 10K on p.13:

MANUFACTURING
The Company does not intend to establish manufacturing capabilities or facilities to produce its drug product candidates (compounds) in the near or mid-term. The Company believes it can contract or partner with third parties for the manufacturing of its investigational compounds at sites registered with the FDA and contract with third-party scientists for pharmaco-kinetic, pharmaco-dynamic and toxicology studies. Such studies generally must be completed prior to filing an investigational new drug (IND) application with the FDA, and an IND is necessary to begin the human safety and efficacy trials of its compounds (Phase 1, 2 and 3).

By way of example, the Company contracted with two Contract Drug Manufacturing Organizations, Evonik Corporation and CoreRx, for preparation of Brilacidin commercial-grade drug substance and drug product, respectively.

Note that the reference is to PRE-IND testing material and that those manufacturers, especially CoreRx, were contracted in the context of B-OM.

Can you jump to the conclusion that Evonik will provide the IV B material needed for a clinical trial of B-CV? If so, the Company had the perfect opportunity to say so in their 7/13 PR and did not:
"As previously released, manufacturing steps are now underway to prepare Brilacidin for COVID-19 clinical trial use, including the sourcing of materials and making of sterile IV drug product."
"Given the continuing coronavirus pandemic, and especially in light of surging cases in the United States, the Company is looking to start a clinical trial with Brilacidin for COVID-19 treatment in Q4 2020. This forecast assumes manufacturing is completed, per the manufacturer’s timeline, and a successful Investigational New Drug (IND) application with the Food and Drug Administration."



ps. unrelated FYI
http://www.globenewswire.com/news-release/2019/06/06/1865400/0/en/Innovation-Pharmaceuticals-Signs-Agreement-for-Advanced-Oral-Tablet-Technology-in-Treating-Inflammatory-Bowel-Disease.html
https://www.bddpharma.com/single-post/2020/02/13/another-success-for-bdds-patented-oralogik-technology-with-positive-clinical-results-for
https://healthcare.evonik.com/product/health-care/en/pages/article.aspx?articleid=144594

[Blue Fin]

Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis.


June 17, 2020
Innovation Pharmaceuticals’ Brilacidin Inhibits SARS-CoV-2 (COVID-19) by 97 Percent in a Human Lung Cell Line
Brilacidin
Data from Ongoing Testing at U.S. Regional Biocontainment Laboratory






I agree, you don't appear to know up from down! If you do you should quit dropping the hints that Brilacidin is failing.