Innovation Pharma Surpasses 50 Percent Enrollment in Phase 2 Clinical Trial of Brilacidin for COVID-19
Innovation Pharmaceuticals announced that enrollment has surpassed 50% of its targeted 120 participants in a Phase 2 clinical trial of Brilacidin for moderate-to-severe COVID-19. The trial is double-blind and placebo-controlled, focusing on hospitalized patients. Brilacidin exhibits potent inhibition against various coronavirus strains and is the only non-peptidic defensin-mimetic drug candidate currently under clinical evaluation for SARS-CoV-2. The company is also pursuing FDA’s Fast Track designation for Brilacidin, aiming to address urgent antiviral needs as COVID-19 cases rise globally.
- Over 60 patients randomized in Phase 2 COVID-19 clinical trial.
- Brilacidin shows in vitro inhibition against multiple coronavirus strains.
- FDA Fast Track designation for Brilacidin may expedite its development.
- Trial demonstrates potential risks associated with developing a new antiviral.
- >60 patients have been randomized in the Company’s ~120-patient Phase 2 COVID-19 clinical trial
- With COVID-19 cases rising worldwide as the coronavirus continues to mutate, the need is greater than ever to develop novel broad spectrum antivirals of the future
WAKEFIELD, Mass., April 28, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that enrollment has surpassed 50 percent of the total targeted number of randomized trial participants (~n=120) in its double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897).
Brilacidin is the only non-peptidic defensin-mimetic drug candidate in the world currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19. Additionally, Brilacidin has shown potent inhibition in vitro against different strains of coronaviruses and alphaviruses (with lab testing against other virus families also underway), supporting Brilacidin’s potential to be developed as a broad spectrum antiviral.
“Achieving over 50 percent trial enrollment represents an important milestone as we advance Brilacidin for treatment of COVID-19,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We are hopeful Brilacidin will emerge not only as an effective COVID-19 therapeutic, but also as a desperately needed broad spectrum antiviral. With the world experiencing a record number of new COVID-19 cases, including nearly 1 million new infections in India across a 3-day period, we remain dedicated to bringing to market a novel antiviral to help ease patient suffering. We look forward to completing our COVID-19 clinical trial and releasing topline results.”
Linked below are recent articles published in the journal Nature. Both reinforce the need for developing novel antiviral drugs, such as Brilacidin, to help address the current COVID-19 crisis, as well as to be prepared to confront future pandemics.
- Funders, now is the time to invest big in COVID drugs (nature.com): Vaccine development has been a resounding success. But the medicine cabinet should have been better stocked.
- The race for antiviral drugs to beat COVID — and the next pandemic (nature.com): Despite dire warnings, a stockpile of ready compounds to fight viral pandemics was sorely lacking. Can drugmakers finally do the right thing?
About Brilacidin and COVID-19
Innovation Pharma is developing Brilacidin for COVID-19 under Fast Track designation from the U.S. Food and Drug Administration (FDA), and currently is enrolling patients in a Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). Upon recently completing a scheduled review of interim safety data from the trial, an independent Data Monitoring Committee (DMC) recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, which may maximize therapeutic benefits and provide a comparison with 5-day remdesivir (Veklury™), currently the only FDA-approved treatment for COVID-19. 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
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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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