WAKEFIELD, Mass., 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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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (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 completed 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. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated in a Phase 2 clinical trial as a potential treatment for COVID-19. With regards to laboratory studies, the Company wishes to note that, while predictive to an extent, are not always indicative of a drug’s performance in a clinical trial. 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. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other coronaviruses, as well as government regulatory approvals to continue clinical testing. Other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that pre-clinical laboratory studies and prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com