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Recruitment and Enrollment Underway at Eight Sites for Innovation Pharma's Phase 2 Clinical Trial of Brilacidin for COVID-19WAKEFIELD, Mass., March 05, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today reports that eight sites are now participating in the Company’s international Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19. The trial is now posted on clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04784897), which shows seven sites as recruiting and enrolling patients. An eighth site is also now enrolling in addition, and the Company has informed clinicaltrials.gov of the change in status. Fifteen patients have already been dosed in the trial. More sites are coming online, which is expected to further accelerate enrollment and treatment. The trial doesn’t exclude any variants of SARS-CoV-2, the virus responsible for COVID-19. Virulent coronavirus strains have scoured different countries around the world recently, including highly contagious versions, such as P1 and B.1.1.7. Brazil this week reported that COVID -19 daily deaths reached a new high due to P1. According to Russian news agency Tass, nearly 1,500 coronavirus mutations have been discovered in Russia, a country where seven sites are currently enrolling patients in the Company’s COVID-19 clinical trial. The Company is interested to see what information, if any, might be gleaned from the trial regarding variants considering laboratory studies have indicated Brilacidin to have strong pan-coronavirus treatment potential, remaining unaffected by viral mutations. “We are pleased to see patient recruitment and enrollment in our Brilacidin for COVID-19 clinical trial ramping up,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “COVID-19 is making a resurgence worldwide, with cases up 9 percent last week in Europe and cases no longer decreasing in the United States. Emerging variants are likely partially to blame for this rise. With its unique three-in-one therapeutic profile—antiviral, anti-inflammatory and antibacterial—we believe Brilacidin can play an important role in treating COVID-19. A broad-spectrum therapeutic that can be shown to inhibit coronaviruses would be a valuable countermeasure in fighting coronavirus disease and other viral outbreaks, now and in the future.” Brilacidin COVID-19 Clinical Trial The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19. Two treatment arms are enrolling patients—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes, all-cause mortality, measurement of disease biomarkers and inflammation-related biomarkers, changes to SARS-CoV-2 viral load, and other key measures. Brilacidin and COVID-19
Global COVID-19 Cases and Mortality Alerts 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 government regulatory approvals to continue 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 |