Innovation Pharma Completes Enrollment in Phase 2 Clinical Trial for COVID-19
Innovation Pharmaceuticals (OTCQB:IPIX) announced full patient enrollment in its Phase 2 clinical trial for Brilacidin, targeting moderate-to-severe COVID-19 in hospitalized patients. The trial, which includes 120 participants, is under U.S. FDA Fast Track designation. Final data collection is anticipated in early August, followed by unblinding and topline results. Brilacidin is unique as a non-peptidic defensin-mimetic drug, demonstrating virucidal properties effective against viral mutations, which may position it as a broad-spectrum antiviral.
- Full enrollment of 120 patients in Phase 2 trial for Brilacidin.
- FDA Fast Track designation for Brilacidin in COVID-19 treatment.
- Brilacidin exhibits unique properties to combat viral mutations.
- None.
WAKEFIELD, Mass., June 03, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announced today that it has achieved full patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). Innovation Pharmaceuticals is developing Brilacidin for treatment of COVID-19 under U.S. FDA Fast Track designation.
Complete trial enrollment comprised 120 dosed patients recruited across multiple sites. Final data collection for the last patient enrolled in the study is expected to occur in early August (Study Day 60), which will then be followed by the process of unblinding study data and the reporting of topline study results.
“We are pleased to have reached this company milestone and particularly thank all of the participating investigator sites and patients, in addition to many others involved in supporting the completion of study enrollment, especially given the challenges brought on by the pandemic,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Encouraged by extensive laboratory-based Brilacidin antiviral research focused on coronaviruses, and building on previous pre-clinical and clinical results demonstrating a robust Brilacidin therapeutic profile, we prioritized the development of Brilacidin as a novel antiviral. To us, this is much more than a COVID-19 study. Our goal is to develop a broad spectrum antiviral not just to help contain today’s pandemic, but also one that could be deployed against other infectious and deadly viruses that inevitably will follow. As such, we eagerly look forward to our Brilacidin COVID-19 trial readout.”
Based on pre-clinical studies, Brilacidin is exhibiting an ability to directly disrupt viral integrity, a potent virucidal property, enabling it to be unaffected by mutations that give rise to variants—a beneficial trait differentiating Brilacidin from other antivirals.
About Brilacidin and COVID-19
Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19. Additionally, Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses (with lab testing against other viruses also underway), supporting Brilacidin’s potential to be developed as a broad spectrum antiviral. The annual global antiviral drug market is estimated to reach
A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
- Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
Two independent Machine Learning studies identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin’s molecular properties. Click here to learn more.
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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 diseases, and dermatologic diseases.
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 viruses, 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 regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; 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.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
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