Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) is heading northbound after the Company along with George Mason University reported testing results demonstrated Brilacidin’s COVID-19 Treatment Potential. In a human lung cell line infected by SARS-CoV-2, Brilacidin achieved a high Selectivity Index of 426. The primary mechanism of action of Brilacidin appears to disrupt viral integrity and block viral entry. Brilacidin and FDA-approved remdesivir exhibit excellent synergistic activity in vitro against SARS-CoV-2.
William F. DeGrado, PhD, Professor in the Department of Pharmaceutical Chemistry at University of California San Francisco and Scientific Advisor to IPIX stated: “Brilacidin’s demonstration of potent antiviral activity against SARS-CoV-2 is important, particularly given its apparent ability to impact the virus directly, This antiviral mechanism of action suggests Brilacidin might be able to inhibit other viruses and be less prone to resistance developing due to viral mutations—a weak spot for other antivirals, antibody-based treatments and vaccines. I am extremely hopeful Brilacidin will emerge as an effective COVID-19 treatment given the ongoing worldwide need for COVID-19 therapeutics.”
Innovation Pharmaceuticals Inc (OTCMKTS: IPIX) headquartered in Wakefield, Massachusetts, (and formerly Cellceutix Corporation: CTIX which ran from pennies to $4.93) is a publicly traded biopharmaceutical company dedicated to discovering and advancing innovative medical therapies with dermatology, oncology, anti-inflammatory, antibiotic and antiviral applications.The Company owns the rights to numerous drug compounds, including Brilacidin for which IPIX owns 10 patents, its lead drug in a new class of compounds called defensin-mimetics currently gaining serious traction as a treatment for coronavirus, and Kevetrin (thioureidobutyronitrile), IPIX lead anti-cancer compound. Brilacidin is being evaluated at a U.S. Regional Biocontainment Laboratory (RBL) and has consistently demonstrated robust in vitro antiviral properties against coronavirus.
IPIX ran big in June to highs of $0.66 after the Company announced Brilacidin Inhibits SARS-CoV-2 (COVID-19) by 97 Percent in a Human Lung Cell Line. Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and by 97 percent, compared to control, at two therapeutic concentrations tested. Based on a CC50 value—the concentration of drug at which 50 percent of cells maintain viability—Brilacidin was also shown to be non-cytotoxic in the lung cell line. The new lung cell line data reinforce previous testing conducted at the RBL, in VERO cells, where Brilacidin showed a similar robust inhibition, of 75 percent, against SARS-CoV-2 compared to control. Brilacidin has also been shown, in testing at the RBL, to be non-cytotoxic in VERO cells.
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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 established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2. In a human lung cell line, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. 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.
Recently IPIX receiving additional data from a U.S. Regional Biocontainment Laboratory (RBL) collected during ongoing in vitro testing supporting Brilacidin as a potential treatment for coronavirus. In human lung epithelial cell line experiments performed at the RBL, Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed a statistically significant and synergistic inhibition of SARS-CoV-2. Of particular note, overall viral load was reduced by 99.85 percent in one combination experiment, with remaining virus dropping to near undetectable levels.
IPIX recently submitted a pre-IND meeting request to the FDA in advance of a planned study of Brilacidin, a defensin-mimetic drug candidate, for the treatment of COVID-19. The request for the pre-IND meeting follows the FDA guidance issued in May 2020, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products”. Confirmation of the meeting being granted by FDA, with return of written responses, has been received. The Company requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis.
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Currently running northbound with power IPIX is fast emerging as one of the most exciting stocks in small caps as Brilacidin continues to show significant progress as a treatment for coronavirus. Brilacidin is being evaluated at a U.S. Regional Biocontainment Laboratory (RBL) and has consistently demonstrated robust in vitro antiviral properties. According to newly received additional data from RBL, Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed a statistically significant and synergistic inhibition of SARS-CoV-2. Of particular note, overall viral load was reduced by 99.85 percent in one combination experiment, with remaining virus dropping to near undetectable levels. If the results continue to show these kind of results, pressure will be intense to approve it for sale. The Company plans a Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis. 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.