FDA Grants IND Approval for Phase 2 Clinical Trial of Innovation Pharmaceuticals’ Brilacidin for Treating COVID-19
December 21, 2020 07:00 ET | Source: Innovation Pharmaceuticals Inc.
Brilacidin’s potent in vitro inhibition of the Washington and Italian strains of SARS-CoV-2 support its potential to inhibit emerging coronavirus mutations (variants), such as those in the United Kingdom, Denmark and South Africa
120-patient trial to be conducted at U.S. and international clinical sites
Primary endpoint time to sustained recovery through Day 29
WAKEFIELD, Mass., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company developing Brilacidin, a Host Defense Protein (HDP) mimetic representing a new class of drug with antiviral, anti-inflammatory and anti-bacterial properties, is pleased to announce that the U.S. Food and Drug Administrations (FDA) has approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19.
Brilacidin has been shown in vitro to be effective against different SARS-CoV-2 strains (Washington and Italian), as well as multiple human coronaviruses, making it less likely to be affected by emerging mutations (in the United Kingdom, Denmark and South Africa) and further differentiating the drug from other COVID-19 treatments in development today.
With its unique HDP mimetic properties, Brilacidin has potential to exert antiviral activity across SARS-CoV-2 variants. The sudden emergence of highly contagious new variants of the coronavirus illuminates the urgent need for drugs, like Brilacidin, with a different mechanism of action from current antivirals to get this resilient virus under control.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, multi-national, multi-center study expected to enroll approximately 120 patients with moderate-to-severe COVID-19. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale. The Company will now complete site initiation visits and contracts to add additional clinical sites to the study.
“It’s clear from comments of infectious disease experts like Dr. Anthony Fauci and recent news reports on emerging COVID-19 variants that we are not out of the woods yet with the coronavirus, by any stretch of the imagination. Even with vaccines starting to be rolled-out, it is going to be many more months for them to reach the masses and potentially years before vaccines are available worldwide,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “There is now and will be into the foreseeable future a real need for new therapeutics to treat people who contract the infection. We have great hopes Brilacidin will emerge as a novel therapeutic to help fight the global pandemic.”
