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Monday, October 18, 2021

Swift Rise of Biotech IPIX (Innovation Pharmaceuticals) as Potent Therapeutic Brilacidin Begins Clinical Trials

IPIX (Innovation Pharmaceuticals) is making a major run up the charts in recent weeks making a move towards its June highs of $0.65 per share on fast growing volume topping several million in dollar volume per day. IPIX has been under heavy accumulation recently and volume has picked up substantially since early December as a new era of penny stock speculators fueled by the robinhood app and its brand new 100 million trading accounts take on the bulletin boards. These are different times than just a few short years ago; now penny stocks such as TSNP can achieve a $6 billion plus market valuation and trade $375 million in dollar volume in a day on the bulletin boards. And TSNP has no stronger fundamentals than IPIX does. IPIX has a long history of legendary runs skyrocketing to $4.93 per share when it was trading as CTIX. Currently making a move on its recent highs, investors are looking for a break over $0.65 for confirmation of the next big leg up. 

It’s easy to get excited about IPIX; the Company’s flagship Brilacidin is quickly emerging as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials for other clinical indications, providing established safety and efficacy data. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). Earlier this month IPIX began its Phase 2 clinical trial of Brilacidin for treating COVID-19. The Phase 2 randomized, placebo-controlled clinical trial includes approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intravenous treatment arms were enrolled—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale.  A non-peer-reviewed study recently reported that Brilacidin Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2. A peer-reviewed study recently published reported that Brilacidin Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2.

Innovation Pharmaceuticals (OTCQB: IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. 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. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently initiated a Phase 1 study with their formulation. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated as a potential treatment for COVID-19.  

Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, 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 established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1β, TNF-α and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential.  

Microcapdaily has been covering IPIX for years starting with CTIX back in 2015 reporting on the stocks legendary run to $4.93 per share. We stated on CTIX back in the day: “As anyone in the industry knows, regulating the p53 pathway has long been the holy grail of cancer research and big pharma has spent hundreds of millions of dollars researching ways to achieve this with no success thus far. It seems Kevetrin(TM) has accomplished this; extensive preclinical research on Kevetrin shows the re-activation of p53 across a wide spectrum of cancer lines including colon, lung, breast and pancreatic cancers. The market potential for Kevetrin in treating drug-resistant cancers is worth $5 billion a year. Other cancers could easily represent an additional $5 billion annually, he adds.”

Investor sentiment in IPIX is high:

https://twitter.com/TopCincoSpaZz/status/1361901994680733697

IPIX has established a valuable intellectual property portfolio: 

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Earlier this month IPIX began its Phase 2 clinical trial of Brilacidin for treating COVID-19. The Phase 2 randomized, placebo-controlled clinical trial includes approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intravenous treatment arms were enrolled—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale. Other endpoints include: in-hospital outcomes, all-cause mortality, measurement of inflammation-related biomarkers, changes to SARS-CoV-2 viral load, and other key measures. The Company believes Brilacidin holds tremendous promise to help address the global pandemic, particularly given the emergence of contagious and virulent coronavirus variants. Data increasingly are showing these variants can significantly lessen the effectiveness of COVID-19 treatments and vaccines. For example, a Phase 2b trial in South Africa showed the Novavax vaccine was less than 50 percent effective against a new coronavirus variant originally identified in that country. 

A key differentiating aspect of Brilacidin’s antiviral mechanism of action is its ability to attack the coronavirus directly by disrupting viral membrane integrity. This suggests Brilacidin would be less prone to resistance developing due to viral mutations. Brilacidin already has been shown to inhibit the Washington and Italian strains of the coronavirus and multiple strains of endemic human coronaviruses (H-CoVs), with additional laboratory testing of Brilacidin planned against new coronavirus variants. Novel therapeutics with broad-spectrum anti-coronavirus properties are, and will continue to be, much-needed as the world confronts the coronavirus pandemic and prepares for the likelihood of future viral pandemics. 

Recently after the FDA approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19 the Company’s CEO Leo Ehrlich stated: “It’s clear from comments of infectious disease experts like Dr. Anthony Fauci and recent news reports on emerging COVID-19 variants that we are not out of the woods yet with the coronavirus, by any stretch of the imagination. Even with vaccines starting to be rolled-out, it is going to be many more months for them to reach the masses and potentially years before vaccines are available worldwide. There is now and will be into the foreseeable future a real need for new therapeutics to treat people who contract the infection. We have great hopes Brilacidin will emerge as a novel therapeutic to help fight the global pandemic.”

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IPIX is making a major run up the charts in recent weeks making a move towards its June highs of $0.65 per share on fast growing volume topping several million in dollar volume per day. IPIX has been under heavy accumulation recently and volume has picked up substantially since early December as a new era of penny stock speculators fueled by the robinhood app and its brand new 100 million trading accounts take on the bulletin boards. These are different times than just a few short years ago; now penny stocks such as TSNP can achieve a $6 billion plus market valuation and trade $375 million in dollar volume in a day on the bulletin boards. And TSNP has no stronger fundamentals than IPIX does. IPIX has a long history of legendary runs skyrocketing to $4.93 per share when it was trading as CTIX. Currently making a move on its recent highs, investors are looking for a break over $0.65 for confirmation of the next big leg up. It’s easy to get excited about IPIX; the Company’s flagship Brilacidin is quickly emerging as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials for other clinical indications, providing established safety and efficacy data. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). Earlier this month IPIX began its Phase 2 clinical trial of Brilacidin for treating COVID-19. The Phase 2 randomized, placebo-controlled clinical trial includes approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intravenous treatment arms were enrolled—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale.  A peer-reviewed study recently published reported that Brilacidin Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2. 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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