Innovation Pharmaceuticals Announces Overseas Regulatory Filing Submitted For COVID-19 Clinical Study
WAKEFIELD, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today that an overseas Clinical Trial Application (CTA) has been submitted to the governing health agency, with a U.S. Investigational New Drug (IND) application also to be submitted this week to the FDA. Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.
The randomized, double-blind, placebo-controlled, multi-center study is anticipated to enroll 120 hospitalized patients with COVID-19. Sufficient Brilacidin intravenous (IV) drug product has been manufactured to complete this trial, and potentially future COVID-19 trials, providing the Company with added flexibility as it develops Brilacidin for the treatment of COVID-19.
In other important news, the Company has been informed by researchers at George Mason University’s Regional Biocontainment Laboratory that new in vitro testing showed Brilacidin exerted similarly potent inhibition against two strains of SARS-CoV-2, the novel coronavirus responsible for COVID-19. These data suggest Brilacidin would likely not be susceptible to resistance developing due to SARS-CoV-2 mutations, unlike many other vaccines and antivirals currently in use and in development.
“Due to the rapid worldwide spread of the COVID-19 pandemic, the need for novel therapeutics to help control this disease has only increased,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “While we all hope for the expedient arrival of safe and effective COVID-19 vaccines, which is one part of the solution, the need for better therapeutics to treat this disease, including its different strains, also remains essential. Vaccines and therapeutics both will play integral roles in addressing the current COVID-19 pandemic and possible future viral pandemics. We are excited by Brilacidin’s potential to treat SARS-CoV-2 and look forward to the start of our upcoming clinical trial, as we continue to advance Brilacidin in the global fight against COVID-19.”
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About Innovation Pharmaceuticals
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 future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other coronaviruses, as well as obtaining government regulatory approvals to commence clinical testing. 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 but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking IND regulatory approval for Brilacidin and Kevetrin; that prior test results may not be replicated in future studies and trials, 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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