WAKEFIELD, MA / 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.”
About Monkeypox3,4,5
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