Vaccine Info

Brilacidin COVID-19 Therapeutic

Authored by
Staff
Last reviewed
April 5, 2021

Brilacidin COVID-19 Antiviral 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 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.

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.

Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the body's innate immune system is a synthetic, non-peptidic small molecule that kills pathogens swiftly, significantly reducing the likelihood of drug resistance developing. Just as importantly, Brilacidin functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing.

On February 9, 2021, the journal Cell Culture published a paper that concluded Brilacidin was shown to exert potent inhibitory effects on SARS-CoV-2 in cell culture by decreasing viral load in different cell types, including ACE2 positive human lung cells, and, importantly, in both the Washington and Italian strains of the coronavirus. Testing of Brilacidin against additional SARS-CoV-2 strains is planned, concluded this paper.

Brilacidin COVID-19 Antiviral History

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.”

Brilacidin and related compounds are protected under various composition and use patents. A patent was filed and is pending for HDP-mimetics in the prophylaxis and/or treatment of inflammatory diseases of the gastrointestinal tract. Another patent for compounds for use in the treatment of mucositis has been awarded numerous global protections. Click here for a bibliography on the development of Brilacidin and the HDP-mimetics program.

On April 5, 2021, Leo Ehrlich, CEO at Innovation Pharmaceuticals stated in a press release, “There is a sense of urgency to develop novel pan-coronavirus therapeutics for COVID-19, particularly given the growing spread of variants worldwide, including P1 and B.1.1.7, which appear to be contributing to cases of infection cropping up in patients who have already been vaccinated. With its unique mechanism of action to directly disrupt the novel coronavirus, we believe Brilacidin possesses the potential to address these worrisome reminders that SARS-CoV-2 isn’t going anywhere. More broadly, Brilacidin’s antiviral potency also appears to extend beyond coronaviruses to other types of viruses, based on independent ongoing laboratory research, further supporting Brilacidin’s broad-spectrum antiviral potential.”

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 Antiviral Indication

Brilacidin COVID-19 therapeutic candidate is a broad-spectrum antiviral for treating common colds and coronavirus infections. 

Brilacidin COVID-19 Antiviral News

April 5, 2021 - Innovation Pharmaceuticals today announced that an independent Data Monitoring Committee (DMC) completed its scheduled review of interim safety data in the Company’s randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. Upon reaching 25 percent enrollment (30 subjects), recruitment was paused and a pre-specified unblinded safety data review and evaluation were conducted by the DMC. Following their review, the DMC recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, as intended per the protocol, which the Company has since implemented. Recruitment for the 5-day treatment regimen has begun. Efficacy data was not reviewed by the DMC and remains blinded.

March 2, 2021 - Innovation Pharmaceuticals announced the publication of a peer-reviewed scientific article—Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture—in the journal Viruses. Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals, commented, “Infectious disease experts have noted the next phase in the global fight against COVID-19 will be in developing potent antivirals that directly act on the SARS-CoV-2 virus—which is what Brilacidin has been shown to do in pre-clinical studies.

February 26, 2021 - Innovation Pharmaceuticals provided additional study details for its ongoing Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19. Patients are being treated, with recruitment and enrollment progressing at trial sites.

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 Antiviral Clinical Trial

Clinical Trial NCT04784897: A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19 - Last posted update on March 5, 2021

This Phase 2 study is a randomized, blinded, placebo-controlled, parallel-group design.

The target population to be treated are 120 patients with moderate to severe COVID-19, SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) within 4 days prior to starting study treatment, and hospitalized with respiratory distress but not yet requiring high-level respiratory support. (