WAKEFIELD, MA – March 10, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report today that a Machine Learning (Artificial Intelligence) model used to screen 1,482 compounds ranked Brilacidin in the top three percent of compounds predicted to be the most effective against SARS-CoV-2, the virus responsible for COVID-19. Published in Bioinformatics, by Oxford University Press, the Machine Learning ranking is based on a compound’s predicted ability, due to its physicochemical properties, to bind to coronavirus proteins and thus inhibit viral replication. The predictive framework used in this research was built by assessing the structure of the main proteins of almost 100 different viral organisms, making the model generalizable to multiple viruses, according to the study’s authors.
The Company is highly encouraged by this independent research suggesting Brilacidin may be one of the best drug candidates capable of attacking and destroying SARS-CoV-2 variants and other coronaviruses, while mitigating or averting the threat of drug resistance developing.
The world has recently seen several clinical trial failures of highly touted treatments against the backdrop of new highly contagious and more virulent COVID-19 variants emerging, including the P1 strain in Brazil. P1, which has been proven extremely adept at re-infecting people, has quickly resulted in Brazilian hospitals being overwhelmed by a deluge of new and repeat cases. This situation has given rise to fears that P1 could cause similar outbreaks should it become widespread in other countries, as reported in yesterday’s Washington Post in an article titled, “Brazil’s growing coronavirus outbreak poses a threat far beyond its borders.”
As described by Centers for Disease Control and Prevention Director, Dr. Rochelle Walensky, in a recent White House briefing, new variants are “a very real threat to our people and our progress,” with the spread of highly contagious coronavirus variants threatening to fuel a “potential fourth surge of cases.” This further lends to the urgency to expeditiously develop novel, broad spectrum antiviral medications to combat the pandemic plaguing the planet for over one year now.
A link to the corresponding independent peer-reviewed article in Bioinformatics is provided below, with a summary of the research available on the Updates section of the Company’s website.
· Mall, R.; Elbasir, A.; Almeer, H.; et al (2021). A Modelling Framework for Embedding-based Predictions for Compound-Viral Protein Activity. Bioinformatics, btab130, https://doi.org/10.1093/bioinformatics/btab130 (Published: 26 February 2021)
A separate independent peer-reviewed in silico screening study of 11,552 compounds comprising already FDA-approved drugs and those in clinical testing, as previously released, also identified Brilacidin as one of the most promising potential inhibitors of SARS-CoV-2.
These two studies complement a growing body of antiviral data—notably, positive pre-clinical Brilacidin testing results against SARS-CoV-2 in multiple cell lines and in different coronavirus strains—supporting Brilacidin’s treatment potential in COVID-19.
Innovation Pharma has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897).
“It is a rewarding moment for me, as one of the discoverers of Brilacidin, to see Brilacidin continue to receive validation as a promising antiviral treatment—based both on in silico molecular modeling studies and lab research,” commented William F. DeGrado, PhD, Professor in the Department of Pharmaceutical Chemistry at University of California San Francisco (UCSF), and Scientific Advisor for Innovation Pharma. “COVID-19 is, in all likelihood, here to stay. Bringing to market effective coronavirus therapeutics with novel mechanisms less prone to drug resistance developing due to mutations, a characteristic Brilacidin is exhibiting, will be important as the world combats this infectious and deadly virus. I look forward to seeing how Brilacidin performs in its Phase 2 trial in hospitalized COVID-19 patients and am hopeful Brilacidin will emerge as an effective antiviral, with added beneficial immunomodulatory properties.”
Brilacidin COVID-19 Clinical Trial
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19. Two treatment arms are enrolling patients—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes, all-cause mortality, measurement of disease biomarkers and inflammation-related biomarkers, changes to SARS-CoV-2 viral load, and other key measures.
Brilacidin and 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. The Company has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of COVID-19 in moderate-to-severe hospitalized patients. A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
· Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website (http://www.ipharminc.com), and at the following link:
https://ipixcovid19tracker.com/
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