In Vitro Testing of Innovation Pharmaceuticals’ Brilacidin for COVID-19 Shows Consistent Anti-SARS-CoV-2 Efficacy; Manufacturing Preparation Underway for COVID-19 Clinical Trial

WAKEFIELD, Mass., July 07, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today reports the latest developments related to research into Brilacidin as a potential treatment for COVID-19. As previously disclosed, Brilacidin is being evaluated at a U.S. Regional Biocontainment Laboratory (RBL) and has consistently demonstrated robust in vitro antiviral properties against SARS-CoV-2, the novel coronavirus responsible for COVID-19.

Most recently, Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2 in a human lung epithelial cell line, reducing viral load by up to 97% compared to control.

The primary investigator at the RBL noted that the human lung cell experiments reflect a similarly robust in vitro antiviral signal against SARS-CoV-2 as assessed in vero cells (animal), with Brilacidin showing consistent demonstration of efficacy across different cell lines. Brilacidin also appears to be showing greatest efficacy in testing when administered as a pre-treatment (virus pre-incubated with Brilacidin prior to infection), in addition to being present during and post-infection.

RBL scientists next plan to determine, in human lung cells, Brilacidin’s Selectivity Index—a ratio determined from in vitro data that compares a drug’s cytotoxicity and antiviral activity. The higher the SI ratio, the more effective and safe a drug has the potential to be in the clinic. These data will help to inform Brilacidin’s inhibitory properties against the novel coronavirus, and allow comparison to other treatments, all to be detailed in a planned peer-review publication.

The Company also reports that all preferred shares and warrants previously allotted as part of a financing arrangement have been exercised, establishing a cash balance of approximately $6 Million as of June 30, 2020.

“With cash reserves in place, we are now planning to quickly prioritize key programs in our pipeline,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “The world continues to suffer from the coronavirus pandemic, both in lives lost and economic devastation. We steadfastly believe that Brilacidin could play a significant role in treating this highly contagious and deadly virus. Steps have begun with the Contract Development and Manufacturing Organization (CDMO) in preparation for upcoming manufacture of the drug product for COVID-19 clinical trial use, to be followed by interactions with relevant Health Authorities to obtain input and guidance on trial design.”

Mr. Ehrlich continued, “Concurrent to the Brilacidin IV solution manufacturing for COVID-19, we are refining drug formulation plans in preparation for a future planned Phase 2 clinical trial of oral Brilacidin in Ulcerative Colitis as part of our larger IBD Program. Business development activity and partnering remain active.”

Brilacidin and COVID-19

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 an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines. 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 potential to inhibit 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. These data collectively support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.

Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/

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 disease, 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. 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. 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 our 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; 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 IND regulatory approval for Brilacidin; 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.

INVESTOR AND MEDIA CONTACT
Innovation Pharmaceuticals Inc.
Leo Ehrlich
[email protected]