FDA Agrees With a Defensin-Mimetic Drug Candidate Study For COVID-19
A biopharmaceutical company announced receipt of written feedback from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company’s planned clinical trial for Brilacidin, a defensin-mimetic drug candidate, for the treatment of COVID-19.
Innovation Pharmaceuticals stated the FDA response completes the Pre-Investigational New Drug (Pre-IND) process.
The Company’s press release on November 2, 2020, said it is now incorporating this feedback and finalizing the trial protocol for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-national study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. The target enrollment for the trial is 120 patients.
Innovation stated it anticipates commencing the Brilacidin for COVID-19 clinical trial in 4Q’2020.
Brilacidin is one of the few drugs targeting COVID-19 that has been 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 rapidly help address the novel coronavirus crisis.
“Getting to the point of being able to advance Brilacidin as a potential treatment for COVID-19 required an enormous amount of time, resources, and team effort,” commented Leo Ehrlich, CEO at Innovation Pharmaceuticals. “From the manufacturing of drug supply to researching Brilacidin’s mechanisms of action in vitro against SARS-CoV-2 in infected cells to now preparing and planning for the COVID-19 clinical study—was an extraordinary effort.”
Ehrlich added: “While no one can predict with certainty how Brilacidin will perform in clinical testing against COVID-19, we are optimistic based on the compelling preclinical antiviral data we have released and Brilacidin’s consistently successful results in other clinical trials.”
“Our hope is Brilacidin for COVID-19 can be an important part of the solution to help rid the world of this deadly coronavirus.”
The Company, based on pre-clinical research conducted in collaboration with George Mason University, has released a preprint, prior to formal peer review submission, demonstrating Brilacidin’s COVID-19 treatment potential.
Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2. In a human lung cell line, Brilacidin achieved a Selectivity Index of 426.
A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment.
Additional preclinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1β, TNF-α, and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients.
Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno / anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate.
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