Innovation Pharmaceuticals Inc (IPIX)

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PR out!!!

Recruitment and Enrollment Underway at Eight Sites for Innovation Pharma’s Phase 2 Clinical Trial of Brilacidin for COVID-19
Brilacidin
WAKEFIELD, MA – March 5, 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.