Brilacidin COVID-19 Therapeutic Description
Brilacidin is a Host Defense Protein (HDP) mimetic representing a new class of drugs with antiviral, anti-inflammatory, and anti-bacterial properties.
Brilacidin (PMX-30063) is a synthetic, non-peptidic small molecule that kills pathogens swiftly, significantly reducing drug resistance development. Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation, and promoting healing.
Brilacidin has the potent ability to inhibit coronaviruses, primarily by disrupting viral integrity and blocking viral entry.
Brilacidin is one of the few drugs targeting COVID-19 tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to help address the novel coronavirus crisis rapidly.
A non-peer-reviewed study reported on October 30, 2020, Brilacidin Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
On December 21, 2020, Innovation Pharmaceuticals announce that the U.S. Food and Drug Administrations had approved the Company’s Investigational New Drug (IND) application to initiate a Phase 2 clinical trial, Brilacidin, in hospitalized patients with COVID-19. Leo Ehrlich, the CEO, stated: “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.”
On January 15, 2021, Leo Ehrlich, CEO at Innovation Pharmaceuticals, commented, “Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research. Fast Track designation is well-timed as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month and should help bring Brilacidin to patients faster in these dire times.”
Headquartered in Wakefield, Massachusetts, Innovation Pharmaceuticals Inc. (formerly Cellceutix Corporation) is a publicly-traded biopharmaceutical company dedicated to discovering and advancing innovative medical therapies dermatology, oncology, anti-inflammatory, antibiotic and antiviral applications.
Brilacidin COVID-19 Therapeutic Indication
Brilacidin Coronavirus Therapeutic candidate is a broad-spectrum antiviral for treating common colds and deadly coronavirus infections.
Brilacidin COVID-19 Therapeutic News
January 14, 2021 - Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track Designation. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2 and multiple strains of human coronaviruses. In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments.
December 21, 2020 - The U.S. FDA Granted IND Approval for Phase 2 Clinical Trial of Innovation Pharmaceuticals’ Brilacidin for Treating COVID-19. Brilacidin’s potent in vitro inhibition of the Washington and Italian strains of SARS-CoV-2 supports its potential to inhibit emerging coronavirus mutations (variants), such as those in the United Kingdom, Denmark, and South Africa.
November 30, 2020 - Innovation Pharmaceuticals COVID-19 Clinical Trial to Support Additional Development of Brilacidin as a “Pan-Coronavirus” Therapeutic. Additional independent preliminary laboratory research suggests Brilacidin, the Company’s flagship defensin mimetic, can treat other endemic human coronaviruses (H-CoVs), such as those causing common colds, and not just SARS-CoV-2, the novel coronavirus responsible for the ongoing global COVID-19 pandemic.
November 16, 2020 - Innovation Pharmaceuticals announced that an overseas Clinical Trial Application (CTA) had been submitted to the governing health agency, with a U.S. Investigational New Drug (IND) application also to be submitted this week to the FDA. Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.
October 30, 2020 - Innovation Pharmaceuticals and George Mason University’s (Mason’s) National Center for Biodefense and Infectious Diseases (NCBID) jointly announced the completion of extensive laboratory testing supporting the anti-SARS-CoV-2 activity of Brilacidin, a defensin-mimetic drug candidate, which is being developed as a potential COVID-19 treatment. “In testing at GMU’s BSL-3 lab, we showed that Brilacidin potently inhibits SARS-CoV-2 in vitro against the live virus. Beyond exhibiting treatment potential for those already infected by COVID-19, Brilacidin’s ability to disrupt viral integrity and block viral entry indicates it has the added potential to prevent infection, upon appropriate formulation, as a prophylactic. I look forward to working with Innovation to investigate further Brilacidin’s antiviral properties,” said Aarthi Narayanan, Ph.D., Associate Professor of Systems Biology in Mason’s College of Science.
Brilacidin COVID-19 Therapeutic Clinical Trial
The Phase 2 clinical trial will be a randomized, double-blind, placebo-controlled, multi-national, multi-center study that is 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.