Innovation Pharmaceuticals Inc (IPIX)

[KMBJN]

I think skepticism from recent lack of progress and communication is well warranted. Agree that more clarity is good, just not sure what to do about it. For instance, we still don't even know where the 2 or 3 labs testing brilacidin are in the testing stages, and which lab is reporting which results for sure.

May 5th PR indicates a second lab, which is referred to as a PHRI, separate from prior RBL:

WAKEFIELD, MA – May 5, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has executed a Material Transfer Agreement (MTA) with a leading U.S.-based Public Health Research Institute, with access to a Biosafety Level-3 (BSL-3) laboratory, to evaluate the immunomodulatory and antiviral properties of Brilacidin in relation to COVID-19. This new research is separate from the previously announced antiviral studies being conducted at a U.S. Regional Biocontainment Laboratory (RBL), which over the weekend informed us that the next phase of Brilacidin testing has commenced.

Scientists at the Public Health Research Institute plan to evaluate Brilacidin’s inhibitory effect on SARS-CoV-2 viral replication in primary immune mediators (peripheral blood mononuclear cells, T cells, B cells, monocytes, macrophages) obtained from both young and old donors to assess age-dependent host responses to the novel coronavirus. Brilacidin drug substance has been received by the Institute and is now available for testing.

May 19th said:

Innovation Pharmaceuticals’ Brilacidin Reduces Viral Titer of SARS-CoV-2 (COVID-19) by 75 percent After Only 1 Hour of Preincubation in In Vitro Study at BSL-3 Facility; Demonstrates Potent and Rapid Virucidal Activity

and later clarified that the BSL-3 lab was the RBL:

May 21, 2020 -In news released on Tuesday, the Company announced that in vitro research being independently conducted at a U.S. Regional Biocontainment Laboratory (RBL) revealed Brilacidin reduced the viral titer (load) of SARS-CoV-2, the novel coronavirus responsible for COVID-19, by 75 percent, as compared to vehicle control after only 1 hour of preincubation prior to infection. The concentration of Brilacidin tested was 10µM.

So, PRs refer to RBL and PHRI testing, presumably both BSL-3 labs.

RBL testing was announced on April 27th to be:

WAKEFIELD, MA – April 27, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has been informed by researchers at the U.S. Regional Biocontainment Laboratory (RBL) that continued coronavirus (COVID-19) testing of Brilacidin, the Company’s defensin-mimetic drug candidate, is scheduled to begin the week of May 4.

Concurrently, the Company is prioritizing Brilacidin’s clinical development by taking steps to rapidly advance Brilacidin testing in human trials, including preparations for engaging with regulatory authorities, as the research continues into the drug’s antiviral properties.

Results from initial testing at the RBL showed that Brilacidin had antiviral activity against SARS-CoV-2 in Vero cells, a screening assay using a monkey epithelial cell-line. Proposed further research studies to be conducted at the RBL include:


Testing Brilacidin’s direct virucidal activity on SARS-CoV-2 in human lung epithelial cells (by preincubating the novel coronavirus with Brilacidin at varying concentrations and times of incubation);
Obtaining the in vitro concentration of Brilacidin that gives half-maximal response, the EC50 value, in lung epithelial cells;
Determining impact of multiple dose exposure of Brilacidin on SARS-CoV-2 (assessing potential for achieving greater virus control without inducing toxicity);
Evaluating time-to-treatment windows as a post-exposure therapeutic (by introducing Brilacidin at 4, 8, and 16 hours post-initial infection, with virus cultures carried forward up to 48 hours);
Exploring if Brilacidin has synergistic properties with other small molecules that have antiviral activity.

So we are still waiting on the results of RBL and PHRI testing on human cells. We don't know where they are at in terms of testing, only that RBL was supposed to have started May 4th, and the the PHRI has the brilacidin on May 5th. Hopefully we get some decent updates next week. It is taking longer than anticipated.

It is good to see that in one of the PRs they are already discussing trials and funding, so, fingers crossed we get more good preclinical testing of brilacidin in human cells against SARS2, and that we get funding to go into trials before long.

Well, it is a beautiful day in my neighborhood, so back to the yardwork and pool.