WAKEFIELD, Mass., March 02, 2020 (GLOBE NEWSWIRE) — March 2, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide scientific rationale and clinical development perspectives for Brilacidin, the Company’s defensin mimetic drug candidate, as a potential novel coronavirus (COVID-19) treatment. Notably, Brilacidin is one of the few drugs targeting COVID-19 that has been tested in humans in Phase 2 clinical trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to rapidly help confront the emerging worldwide coronavirus crisis.
Linked below is an overview document (a downloadable pdf) summarizing the scientific rationale for developing Brilacidin as a potential COVID-19 treatment, both as an intravenous medication and as a possible vaccine.
“Background and Scientific Rationale for Brilacidin as a Potential Novel Coronavirus (COVID-19) Treatment” (March 1, 2020)
Defensins are small antimicrobial peptides expressed widely in the animal kingdom that serve as the first line of defense against foreign invasion of the body.
Defensin-based therapeutics—of which Brilacidin is the leading example, and the most advanced drug candidate among this class currently in clinical testing—represent an attractive possible intervention to combat the coronavirus given innate and multifaceted immunomodulatory properties. Defensins exhibit a number of distinct and highly favorable therapeutic characteristics: anti-bacterial, anti-inflammatory, anti-fungal, anti-biofilm, anti-cancer, and antiviral.
Brilacidin, a mimetic of defensins, was computationally designed to be smaller (1/10th the size), more stable, more potent (by a 100-fold) and more selective (by a 1000-fold) than natural defensins, a type of antimicrobial peptide, so as to overcome most shortcomings (e.g., degradation, toxicity, malabsorption, high-cost of manufacturing) that have complicated their clinical development. The antiviral properties of natural defensins and their synthetic mimics are actively being studied by virologists the world over, with newer understandings elucidating their direct mechanisms of action against non-enveloped and enveloped viruses alike, along with their role in the regulation of inflammation and chemoattraction.
As disclosed, the Company is shipping Brilacidin drug substance this week to a U.S.-based Regional Biocontainment Lab (RBL) to evaluate its potential antiviral and anti-inflammatory properties in the context of viral infections, including inhibition of SARS-CoV-2, the virus responsible for COVID-19. It is anticipated that these tests might be completed within several weeks of the RBL’s receipt of Brilacidin. Separately, a Material Transfer Agreement (MTA), with a leading University Virology Lab overseen by one the world’s top coronavirus experts, is anticipated to be executed this week. The Company has also submitted a preliminary summary of Brilacidin’s potential as a novel coronavirus treatment to the U.S. Government’s Biomedical Advanced Research and Development Authority (BARDA), dedicated to rapidly identifying and funding medical countermeasures to COVID-19. There is no assurance made or implied that testing of Brilacidin for any coronavirus will be successful.
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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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