Innovation Pharmaceuticals’ Phase 2 Clinical Trial of Brilacidin for Treating COVID-19 Scheduled to Begin Next Week

Wakefield, Massachusetts, UNITED STATES

  • Brilacidin treatment unlikely to be impacted by coronavirus variants, such as those originating in the U.K., South Africa and Brazil, and spreading worldwide, due to its ability to attack the virus directly

WAKEFIELD, Mass., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today that the Company’s Phase 2 clinical trial of Brilacidin for treating COVID-19 is scheduled to begin next week.

The Phase 2 randomized, placebo-controlled clinical trial is to include approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intravenous treatment arms are to be 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.

The Company looks forward to the start of its clinical trial to further evaluate Brilacidin’s COVID-19 treatment potential. 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.

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. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.

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 ( ), and at the following link:

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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 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. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated as a potential treatment for COVID-19. 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 .

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 obtaining government regulatory approvals to commence 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 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.

Innovation Pharmaceuticals Inc. 
Leo Ehrlich