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Saturday, November 26, 2022

Scientific Rationale for Brilacidin Boosts Innovation Pharmaceuticals Inc (OTCMKTS: IPIX)

Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) is among the most active stocks on the OTCQB and up big after the Wakefield Mass biotech provided scientific rationale and clinical development perspectives for Brilacidin, the Company’s defensin mimetic drug candidate, as a potential novel coronavirus (COVID-19) treatment.

This follows a prior IPIX announcement it had signed a Material Transfer Agreement (MTA) with a leading University Virology Lab overseen by one the world’s top coronavirus experts. First breaking out in Wuhan, China in December, the new coronavirus COVID-19 has spread to over 50 countries without any effective approved therapies.

Brilacidin is one of the few drugs targeting COVID-19 that has been tested in humans in Phase 2 clinical trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to rapidly help confront the emerging worldwide coronavirus crisis.

“Brilacidin, a mimetic of defensins, was computationally designed to be smaller (1/10th the size), more stable, more potent (by a 100-fold) and more selective (by a 1000-fold) than natural defensins, a type of antimicrobial peptide, so as to overcome most shortcomings (e.g., degradation, toxicity, malabsorption, high-cost of manufacturing) that have complicated their clinical development. The antiviral properties of natural defensins and their synthetic mimics are actively being studied by virologists the world over, with newer understandings elucidating their direct mechanisms of action against non-enveloped and enveloped viruses alike, along with their role in the regulation of inflammation and chemoattraction.”

As disclosed, IPIX is shipping Brilacidin drug substance this week to a U.S.-based Regional Biocontainment Lab (RBL) to evaluate its potential antiviral and anti-inflammatory properties in the context of viral infections, including inhibition of SARS-CoV-2, the virus responsible for COVID-19. It is anticipated that these tests might be completed within several weeks of the RBL’s receipt of Brilacidin. Separately, a Material Transfer Agreement (MTA), with a leading University Virology Lab overseen by one the world’s top coronavirus experts, is anticipated to be executed this week. The Company has also submitted a preliminary summary of Brilacidin’s potential as a novel coronavirus treatment to the U.S. Government’s Biomedical Advanced Research and Development Authority (BARDA), dedicated to rapidly identifying and funding medical countermeasures to COVID-19. There is no assurance made or implied that testing of Brilacidin for any coronavirus will be successful.

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Headquartered in Beverly, Massachusetts, Innovation Pharmaceuticals is a publicly-traded clinical stage biopharmaceutical company. IPIX anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Innovation Pharmaceuticals has commenced a Phase 2 study.

Innovation Pharmaceuticals is in a Phase 2 clinical trial with its novel compound Brilacidin-OM (a defensin mimetic compound) for the prevention of oral mucositis in patients with head and neck cancer. Interim analysis has shown Brilacidin-OM to have a high potential for prevention of severe oral mucositis. Brilacidin has also completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”).

According to one online poster with the handle farrell90: “The MERS and SARS epidemics were both coronaviruses which resulted in a high rate of fatal respiratory failure. Reviewing results the acute treatments with antibiotics, steroids and supportive care once patients developed severe pulmonary involvement, all the patients died. Link below of retrospective review showed all the MERS patients admitted to a middle eastern hospital ICU died.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4839124/

From the IPIX coronavirus Blog PDF page 5 is an exciting article which showed inhaled defensins in an animal model reduced the death rate to zero. 75% of the controls died. I believe that is why research scientist are looking at Brilacidin. ThePDE3/PED4 inhibition most likely plays a role in this effect. Reducing pulmonary inflammation and fibrosis may be the key to treating these critically ill patients.

https://static1.squarespace.com/static/5715352e20c647639137f992/t/5e59c166b728573d1b54f8dc/1582940526011/IPIX+Brilacidin+Defensin+Mimetics+-+COVID-19+Overview+Feb+2020+10pg+final.pdf

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If the Brilacidin for coronavirus effectiveness is confirmed with in vitro testing at the biologic testing centers I would not be surprised to see Brilacidin in 2 arms in the subsequent FDA trials ,1 as an aerosol and a second IV infusion. The aersol approval might open the door to Brilacidin aerosol for a number of pulmonary conditions: asthma, COPD, cystic fibrosis,bronchiectasis, chronic bronchitis perhaps even inflammatory scarring disorders such as pulmonary fibrosis and pneumonconiosis. It could be a bigger market than the GI market and if the government and if FDA facilitate the study it may be at little to no cost. We will be updating on IPIX when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with IPIX.

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Disclosure: we hold no position in IPIX either long or short and we have not been compensated for this article.

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