with a U.S. Investigational New Drug (IND) application also to be submitted this week to the FDA.
...like I’ve been saying @JustFacts
Glad to see this finally announced. SLOW progress, but at least its being made.
Innovation Pharmaceuticals Announces Overseas Regulatory Filing Submitted For COVID-19 Clinical Study
New in vitro data also demonstrates Brilacidin’s anti-SARS-CoV-2 potency is unlikely to be impacted by mutations in different strains of the virus
WAKEFIELD, MA – November 16, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today that an overseas Clinical Trial Application (CTA) has 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.
The randomized, double-blind, placebo-controlled, multi-center study is anticipated to enroll 120 hospitalized patients with COVID-19. Sufficient Brilacidin intravenous (IV) drug product has been manufactured to complete this trial, and potentially future COVID-19 trials, providing the Company with added flexibility as it develops Brilacidin for the treatment of COVID-19.
In other important news, the Company has been informed by researchers at George Mason University’s Regional Biocontainment Laboratory that new in vitro testing showed Brilacidin exerted similarly potent inhibition against two strains of SARS-CoV-2, the novel coronavirus responsible for COVID-19. These data suggest Brilacidin would likely not be susceptible to resistance developing due to SARS-CoV-2 mutations, unlike many other vaccines and antivirals currently in use and in development.
“Due to the rapid worldwide spread of the COVID-19 pandemic, the need for novel therapeutics to help control this disease has only increased,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “While we all hope for the expedient arrival of safe and effective COVID-19 vaccines, which is one part of the solution, the need for better therapeutics to treat this disease, including its different strains, also remains essential. Vaccines and therapeutics both will play integral roles in addressing the current COVID-19 pandemic and possible future viral pandemics. We are excited by Brilacidin’s potential to treat SARS-CoV-2 and look forward to the start of our upcoming clinical trial, as we continue to advance Brilacidin in the global fight against COVID-19.”
Brilacidin and COVID-19 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. 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 pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1ß, TNF-a 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. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded on bioRxiv.org at the link below.
Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
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