WAKEFIELD, Mass., Feb. 24, 2020 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announced today the Company submitted a Material Transfer Agreement (MTA) with a leading U.S.-based virology laboratory to research its lead defensin mimetic drug candidate, Brilacidin as a potential novel coronavirus treatment. Brilacidin has demonstrated broad and robust antibacterial, anti-inflammatory and immunomodulatory properties in multiple FDA clinical trials in different indications.
Under terms of the agreement, Brilacidin’s potential inhibition of SARS-CoV-2, the virus responsible for COVID-19, is planned to be assessed.
Discussions also are underway with a government-funded virology laboratory in Asia, to assess Brilacidin across a range of RNA viruses. On a related note, the Company has submitted a preliminary summary of Brilacidin’s potential as a novel coronavirus treatment to the Biomedical Advanced Research and Development Authority (BARDA), which is dedicated to rapidly identifying and funding medical countermeasures to the COVID-19 outbreak.
As previously released, and as supported in the academic literature, defensin-based therapeutics represent an attractive potential intervention to combat coronavirus infections given their innate multifaceted immunomodulatory properties. Brilacidin, and other defensin mimetics similar in structure, have been tested against numerous clinical isolates of both gram-positive and gram-negative infectious pathogens, with strong activity exhibited across multiple isolates. Enveloped viruses have also been tested, with moderate activity noted.
The Review Article on coronaviruses linked to below suggests immunomodulators, like Brilacidin, might be promising therapeutic options, acting synergistically when combined with other antivirals.
- Zumia, A., et al. “Coronaviruses – Drug Discovery and Therapeutic Options.” Nat Rev Drug Discov. 2016 May;15(5):327-47. doi: 10.1038/nrd.2015.37. Epub 2016 Feb 12. https://www.nature.com/articles/nrd.2015.37
The underlying theory is that once the viral load is reduced, the body’s natural immune response—possibly strengthened by Brilacidin administered post-infection as an adjuvant therapy—should be better able to fight off coronavirus complications. Defensin-based vaccines also have been proposed. Brilacidin, shown in pre-clinical tests to inhibit PDE4/PDE3, might provide added benefit as a result of this particular mechanism by: 1) disrupting viral replication; and 2) enhancing the protective role of natural surfactants in the lung, helping resolve respiratory problems common to the coronavirus.
Should laboratory tests support Brilacidin’s antiviral activity against SARS-CoV-2 (COVID-19), and potentially other RNA viruses, the Company will look to expedite research and clinical development of Brilacidin as a potential antiviral therapy via pharmaceutical partnerships, academic collaborations and government grants.
The current coronavirus (COVID-19) outbreak continues to pose a significant life-threatening risk in China and throughout the rest of the world. Currently, over 79,000 cases have been diagnosed across 29 countries, including the U.S., resulting in nearly 2,600 reported deaths. There are growing signs the global economy is being severely impacted due to this emerging potential pandemic.
If the MTA is concluded, as the Company expects, the drug will be put into queue for testing. There is no assurance made or implied that testing of Brilacidin for any coronavirus will be conducted or successful. The Company will keep shareholders apprised of news related to evaluating Brilacidin’s antiviral properties for potentially treating COVID-19, and other viruses, in addition to its core Brilacidin programs, in Ulcerative Colitis and Oral Mucositis.
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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 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 the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our future drug development plans, 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, 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.
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Innovation Pharmaceuticals Inc.