WAKEFIELD, MA / ACCESSWIRE / August 5, 2022 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today announced that Brilacidin, the Company's defensin-mimetic drug candidate exhibiting broad-spectrum antiviral properties, is to be evaluated for its treatment potential against the monkeypox virus.
To establish potential proof-of-concept, in vitro testing initially will be conducted in orthopoxviruses1 (poxviruses) related to monkeypox -- such as vaccinia and cowpox -- through a collaboration with National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID) scientists. Testing in poxviruses builds on earlier NIH/NIAID-affiliated research of Brilacidin in other acutely infectious virus families, including coronaviruses, alphaviruses, flaviviruses, and filoviruses, with a corresponding scientific paper being prepared for publication.
Given Brilacidin has exhibited antiviral activity in multiple virus families, the Company is excited that Brilacidin will be tested in poxviruses. Academic literature supports Brilacidin's potential in poxviruses. For example, LL-37 and CRAMP, types of natural antimicrobial peptides with similar properties to those of Brilacidin but without the advantages of synthetic design, have been shown in vitro and in vivo to exert antiviral activity against the poxvirus vaccinia.2
"On the heels of the COVID-19 pandemic, which shows few signs of ending, the world is facing another viral outbreak in monkeypox," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "Unfortunately, there are no approved or authorized treatments in the U.S. for monkeypox, with, for the most part, only one drug -- TPOXX™ -- made available to clinicians under compassionate use requests. TPOXX™ was approved by the FDA in 2018 for the treatment of smallpox based on in vivo studies in related poxviruses. Should Brilacidin data in poxviruses be positive, we plan to take aggressive steps to pursue an abbreviated FDA pathway in a bid to provide an alternative treatment to help combat monkeypox."
Monkeypox is a contagious virus characterized by painful skin lesions and rashes and typically spreads through close physical contact. Symptoms usually start within 3 weeks of exposure to the virus, with the illness lasting 2 to 4 weeks. According to the World Health Organization (WHO) Emergency Dashboard, over 26,500 monkeypox cases have been reported in 92 countries. The Centers for Disease Control and Prevention (CDC) has indicated between 1.6 and 1.7 million people in the U.S. are at highest risk of monkeypox infection. The WHO has declared the global monkeypox outbreak a Public Health Emergency of International Concern, a designation reserved for only the most serious viral outbreaks, such as COVID-19, Zika and Ebola. The U.S. Department of Health and Human Services has also declared monkeypox a national public health emergency.
In the U.S., only two vaccines may be used for prevention of monkeypox (JYNNEOS™ and ACAM2000™) and there are no drugs yet approved or authorized for treatment of monkeypox. The antiviral tecovirimat (TPOXX™), approved in 2018 for treatment of smallpox under the FDA's Animal Rule (approval was granted based on well-controlled animal studies), is available for clinical use against monkeypox, via oral or IV delivery, but only under Expanded Access ("compassionate use") protocols. TPOXX™ is made available to clinicians in the U.S. through the Strategic National Stockpile (SNS), a national repository of antibiotics, antivirals, vaccines, antidotes, antitoxins, as well as other critical medical supplies, that can be readily accessed during disease outbreaks.
1 Orthopoxviruses Pathogenic for Humans | SpringerLink
2 Selective Killing of Vaccinia Virus by LL-37: Implications for Eczema Vaccinatum | The Journal of Immunology (jimmunol.org)
3 Monkeypox | Poxvirus | CDC
4 Monkeypox Outbreak 2022 - Global (who.int)
5 Tecovirimat and the Treatment of Monkeypox - Past, Present, and Future Considerations | NEJM
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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.
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