WAKEFIELD, MA – July 7, 2020 (GLOBE NEWSWIRE) In
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Posted On: 07/07/2020 8:11:34 AM
WAKEFIELD, MA – July 7, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today reports the latest developments related to research into Brilacidin as a potential treatment for COVID-19. As previously disclosed, Brilacidin is being evaluated at a U.S. Regional Biocontainment Laboratory (RBL) and has consistently demonstrated robust in vitro antiviral properties against SARS-CoV-2, the novel coronavirus responsible for COVID-19.
Most recently, Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2 in a human lung epithelial cell line, reducing viral load by up to 97% compared to control.
The primary investigator at the RBL noted that the human lung cell experiments reflect a similarly robust in vitro antiviral signal against SARS-CoV-2 as assessed in vero cells (animal), with Brilacidin showing consistent demonstration of efficacy across different cell lines. Brilacidin also appears to be showing greatest efficacy in testing when administered as a pre-treatment (virus pre-incubated with Brilacidin prior to infection), in addition to being present during and post-infection.
RBL scientists next plan to determine, in human lung cells, Brilacidin’s Selectivity Index—a ratio determined from in vitro data that compares a drug’s cytotoxicity and antiviral activity. The higher the SI ratio, the more effective and safe a drug has the potential to be in the clinic. These data will help to inform Brilacidin’s inhibitory properties against the novel coronavirus, and allow comparison to other treatments, all to be detailed in a planned peer-review publication.
The Company also reports that all preferred shares and warrants previously allotted as part of a financing arrangement have been exercised, establishing a cash balance of approximately $6 Million as of June 30, 2020.
“With cash reserves in place, we are now planning to quickly prioritize key programs in our pipeline,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “The world continues to suffer from the coronavirus pandemic, both in lives lost and economic devastation. We steadfastly believe that Brilacidin could play a significant role in treating this highly contagious and deadly virus. Steps have begun with the Contract Development and Manufacturing Organization (CDMO) in preparation for upcoming manufacture of the drug product for COVID-19 clinical trial use, to be followed by interactions with relevant Health Authorities to obtain input and guidance on trial design.”
Mr. Ehrlich continued, “Concurrent to the Brilacidin IV solution manufacturing for COVID-19, we are refining drug formulation plans in preparation for a future planned Phase 2 clinical trial of oral Brilacidin in Ulcerative Colitis as part of our larger IBD Program. Business development activity and partnering remain active.”
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of
for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines. 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 potential to inhibit 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. These data collectively support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.
Most recently, Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2 in a human lung epithelial cell line, reducing viral load by up to 97% compared to control.
The primary investigator at the RBL noted that the human lung cell experiments reflect a similarly robust in vitro antiviral signal against SARS-CoV-2 as assessed in vero cells (animal), with Brilacidin showing consistent demonstration of efficacy across different cell lines. Brilacidin also appears to be showing greatest efficacy in testing when administered as a pre-treatment (virus pre-incubated with Brilacidin prior to infection), in addition to being present during and post-infection.
RBL scientists next plan to determine, in human lung cells, Brilacidin’s Selectivity Index—a ratio determined from in vitro data that compares a drug’s cytotoxicity and antiviral activity. The higher the SI ratio, the more effective and safe a drug has the potential to be in the clinic. These data will help to inform Brilacidin’s inhibitory properties against the novel coronavirus, and allow comparison to other treatments, all to be detailed in a planned peer-review publication.
The Company also reports that all preferred shares and warrants previously allotted as part of a financing arrangement have been exercised, establishing a cash balance of approximately $6 Million as of June 30, 2020.
“With cash reserves in place, we are now planning to quickly prioritize key programs in our pipeline,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “The world continues to suffer from the coronavirus pandemic, both in lives lost and economic devastation. We steadfastly believe that Brilacidin could play a significant role in treating this highly contagious and deadly virus. Steps have begun with the Contract Development and Manufacturing Organization (CDMO) in preparation for upcoming manufacture of the drug product for COVID-19 clinical trial use, to be followed by interactions with relevant Health Authorities to obtain input and guidance on trial design.”
Mr. Ehrlich continued, “Concurrent to the Brilacidin IV solution manufacturing for COVID-19, we are refining drug formulation plans in preparation for a future planned Phase 2 clinical trial of oral Brilacidin in Ulcerative Colitis as part of our larger IBD Program. Business development activity and partnering remain active.”
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of
for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines. 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 potential to inhibit 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. These data collectively support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.
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