● In pre-clinical studies, Brilacidin shown to synergize with marketed antifungals against pathogenic species of aspergillosis, candidiasis, cryptococcosis and mucormycosis, and further exhibited potent stand-alone efficacy against Cryptococcus neoformans
● These data suggest Brilacidin has potential as a novel antifungal agent
Wakefield, MA - 
(NewMediaWire) - October 04, 2022 - Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced publication of a scientific article on the antifungal activity of Brilacidin, the Company’s defensin-mimetic drug candidate with antimicrobial and immunomodulatory properties. The paper, accessible at the link below as a preprint and to be submitted for peer review, is based on independent research conducted primarily by scientists at the University of São Paulo, Brazil. A corresponding patent application related to this work has been filed.
● Fernanda dos Reis T, Alves de Castro P, Bastos R, Pinzan CF, Souza PFN, Ackloo S, Hossain MA, Drewry D, Alkhazraji S, Ibrahim A, Hyunil J, DeGrado WF. “A Host Defense Peptide Mimetic, Brilacidin, Potentiates Caspofungin Antifungal Activity Against Human Pathogenic Fungi.”
bioRxiv 2022.09.28.509882;doi.org/10.1101/2022.09.28.509882
Summary of Brilacidin Antifungal Research Findings
Following an in vitrodrug screening of 1,402 compounds, Brilacidin showed promising antifungal activity and was subsequently selected for additional pre-clinical evaluation, including in combination with caspofungin (CAS), voriconazole (VOR), and posaconazole (POSA), all current antifungal treatments.
In cell culture, in Aspergillus fumigatus(A. fumigatus), Brilacidin converted CAS from a fungistatic into a fungicidal drug, enabling it to overcome both drug resistance and biofilm formation. Brilacidin exerted, to a lesser degree, synergistic effects with VOR in A. fumigatus. Further in vitrotesting showed Brilacidin synergized with CAS in C. albicans, C. aurisandC. neoformans. In an A. fumigatusimmunosuppressed mouse model in invasive pulmonary aspergillosis, Brilacidin plus CAS cleared infection in the lungs by almost 95 percent, compared to ~50 percent when each compound was administered individually. Brilacidin also showed in vitroan additive inhibitory effect when combined with POSA in several species of Mucorales, the main etiological agents of mucormycosis, commonly referred to as black fungus. Mortality rates can be as high as 90 percent in this fungal disease.
Interestingly, Brilacidin showed potent in vitrostand-alone efficacy (MIC=2.5µM) in C. neoformans, a major driver of illness in people living with HIV/AIDS. C. neoformans, for which few effective treatments are available, causes an estimated 220,000 cases of cryptococcal meningitis worldwide each year and is associated with an 80 percent mortality rate.
A proposed antifungal mechanism of action of Brilacidin involves membrane depolarization by impacting calcineurin and cell wall integrity, as informed by protein kinase inhibitory experiments and genetic screenings of protein phosphatase null mutants.
“It is a remarkable feature of Brilacidin that it can potentiate multiple antifungals, in different pathogenic fungi, including hard-to-treat species. New antifungal combination strategies are urgently needed due to a scarcity of novel agents, alongside emerging resistance in the clinical setting,” commented Gustavo Henrique Goldman, Professor of Molecular Biology, University of São Paulo, Brazil, and a Chief Editor for Frontiers in Fungal Biology, a peer-reviewed journal dedicated to the study of mycology. “Another notable finding from our research is that Brilacidin shows exceptional potency of its own as a monotherapy against C. neoformans, a particularly problematic fungus. We look forward to broadening our planned studies of Brilacidin’s antifungal properties.”
About Antifungal Diseases 1, 2, 3
There are up to 5 million fungal species populating the earth, of which approximately 100,000 species have been identified. About 300 fungal species cause disease in humans. Overall, Candida, Cryptococcusand Aspergillusrepresent the main causative organisms of invasive fungal infections. There is a large unmet medical need for developing novel antifungal agents, particularly given the emergence of resistance in the clinical setting. The utility of current antifungal treatments is limited due to toxicity, fungistatic and not fungicidal properties, as well as drug interaction concerns. In the United States, antifungal drugs can qualify for expedited clinical development, under Qualified Infectious Disease Product designation, Orphan Drug designation, and the limited population pathway development program. Pivotal clinical trials for antifungal drugs are generally smaller than those in other infectious disease areas, requiring between 300 and 600 patients. Caspofungin sales were estimated to be $414 million in 2021, with the global antifungal drugs market estimated at $14.8 billion in 2021 and expected to reach $20.5 billion by 2030.
1Current Antimycotics, New Prospects, and Future Approaches to Antifungal Therapy
2Global Caspofungin Market Research Report 2022 (Status and Outlook)
3Antifungal Drugs Market Size to be worth $20.5 Billion by 2030: Grand View Research, Inc.
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.
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, without limitation, statements concerning future product development plans, including with respect to specific indications; statements regarding the therapeutic potential and capabilities of the StingRay System; future regulatory developments; and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause 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 risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals in the United States and other jurisdictions, including without limitation that compounds and devices 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; prior test results may not be replicated in future studies and trials; 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; and the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company’s filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company’s ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and 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
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