· Brilacidin treatment unlikely to be impacted by coronavirus variants, such as those originating in the U.K., South Africa and Brazil, and spreading worldwide, due to its ability to attack the virus directly
WAKEFIELD, MA – January 29, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today that the Company’s Phase 2 clinical trial of Brilacidin for treating COVID-19 is scheduled to begin next week.
The Phase 2 randomized, placebo-controlled clinical trial is to include approximately 120 hospitalized patients with moderate-to-severe COVID-19. Two intravenous treatment arms are to be enrolled—active and placebo, with ~60 patients per arm. 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. Other endpoints include: in-hospital outcomes, all-cause mortality, measurement of inflammation-related biomarkers, changes to SARS-CoV-2 viral load, and other key measures.
The Company believes Brilacidin holds tremendous promise to help address the global pandemic, particularly given the emergence of contagious and virulent coronavirus variants. Data increasingly are showing these variants can significantly lessen the effectiveness of COVID-19 treatments and vaccines. For example, a Phase 2b trial in South Africa showed the Novavax vaccine was less than 50 percent effective against a new coronavirus variant originally identified in that country.
A key differentiating aspect of Brilacidin’s antiviral mechanism of action is its ability to attack the coronavirus directly by disrupting viral membrane integrity. This suggests Brilacidin would be less prone to resistance developing due to viral mutations. Brilacidin already has been shown to inhibit the Washington and Italian strains of the coronavirus and multiple strains of endemic human coronaviruses (H-CoVs), with additional laboratory testing of Brilacidin planned against new coronavirus variants.
The Company looks forward to the scheduled start of its clinical trial to further evaluate Brilacidin’s COVID-19 treatment potential. Novel therapeutics with broad-spectrum anti-coronavirus properties are, and will continue to be, much-needed as the world confronts the coronavirus pandemic and prepares for the likelihood of future viral pandemics.
Brilacidin and COVID-19
Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, 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. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). 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. Additional pre-clinical 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, with pan-coronavirus treatment potential. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.
· Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full