Innovation Pharmaceuticals, a clinical stage biopharmaceutical company, announced that it has achieved full patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients. Innovation Pharmaceuticals is developing Brilacidin for treatment of COVID-19 under U.S. FDA Fast Track designation.
Complete trial enrollment comprised 120 dosed patients recruited across multiple sites. Final data collection for the last patient enrolled in the study is expected to occur in early August (Study Day 60), which will then be followed by the process of unblinding study data and the reporting of topline study results.
“We are pleased to have reached this company milestone and particularly thank all of the participating investigator sites and patients, in addition to many others involved in supporting the completion of study enrollment, especially given the challenges brought on by the pandemic,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Encouraged by extensive laboratory-based Brilacidin antiviral research focused on coronaviruses, and building on previous pre-clinical and clinical results demonstrating a robust Brilacidin therapeutic profile, we prioritized the development of Brilacidin as a novel antiviral. To us, this is much more than a COVID-19 study. Our goal is to develop a broad spectrum antiviral not just to help contain today’s pandemic, but also one that could be deployed against other infectious and deadly viruses that inevitably will follow. As such, we eagerly look forward to our Brilacidin COVID-19 trial readout.”
Based on pre-clinical studies, Brilacidin is exhibiting an ability to directly disrupt viral integrity, a potent virucidal property, enabling it to be unaffected by mutations that give rise to variants—a beneficial trait differentiating Brilacidin from other antivirals.
About Brilacidin and COVID-19
Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19. Additionally, Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses (with lab testing against other viruses also underway), supporting Brilacidin’s potential to be developed as a broad spectrum antiviral. The annual global antiviral drug market is estimated to reach $44 billion by 2026.