Also from the 10-Q: Brilacidin COVID-19 —
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Posted On: 11/16/2020 10:29:13 AM
Also from the 10-Q:
Brilacidin
COVID-19 — Due to the global COVID-19 pandemic, the Company was approached by a number of organizations to research Brilacidin against the novel coronavirus. Material Transfer Agreements were signed with two academic institutions that operate Biosafety Level 3 Laboratories (BSL 3). Brilacidin drug substance (Brilacidin tetrahydrochloride) was provided for antiviral research.
The research data demonstrate that Brilacidin exerts potent inhibition of SARS-CoV-2 and thus supports Brilacidin as a promising COVID-19 drug candidate. Also of note, Brilacidin has demonstrated excellent synergistic antiviral activity when combined with remdesivir.
Research Highlights:
· Brilacidin potently inhibits SARS-CoV-2 in an ACE2 positive human lung cell line.
· Brilacidin achieved a high Selectivity Index of 426 (CC50=241μM/IC50=0.565μM).
· Brilacidin’s main mechanism appears to disrupt viral integrity and impact viral entry.
· Brilacidin and remdesivir exhibit excellent synergistic activity against SARS-CoV-2.
In a broader context, demonstration of Brilacidin’s direct antiviral activity against the SARS-CoV-2 virus, supports the drug’s unique 3-in-1 therapeutic potential—antiviral, anti-inflammatory, antimicrobial—to treat COVID-19 and its associated complications.
Given the safety and efficacy data already known about Brilacidin from pre-clinical and clinical studies utilizing multiple routes of administration, a Phase 2 clinical trial of intravenously-administered Brilacidin for COVID-19 is being planned, with a trial initiation targeted for the fourth quarter of calendar year 2020. The Company filed a pre-IND meeting request with the US FDA for the study of Brilacidin for the treatment of COVID-19. FDA feedback has been received and the Company is now finalizing the Phase 2 clinical protocol, and anticipates submitting a US IND application in November 2020 for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in COVID-19 hospitalized patients. Target enrollment is 120 patients. Contract Research Organizations have been secured to expedite trial enrollment, with many clinical sites expressing interest in participating in the study.
Partnering opportunities with industry and academic partners are ongoing regarding the COVID-19 program. The Company through discussions with industry, academic consultants, and potential partners will also explore investigation of treatment with Brilacidin by inhaled administration for the prevention of COVID-19 infection.
Brilacidin
COVID-19 — Due to the global COVID-19 pandemic, the Company was approached by a number of organizations to research Brilacidin against the novel coronavirus. Material Transfer Agreements were signed with two academic institutions that operate Biosafety Level 3 Laboratories (BSL 3). Brilacidin drug substance (Brilacidin tetrahydrochloride) was provided for antiviral research.
The research data demonstrate that Brilacidin exerts potent inhibition of SARS-CoV-2 and thus supports Brilacidin as a promising COVID-19 drug candidate. Also of note, Brilacidin has demonstrated excellent synergistic antiviral activity when combined with remdesivir.
Research Highlights:
· Brilacidin potently inhibits SARS-CoV-2 in an ACE2 positive human lung cell line.
· Brilacidin achieved a high Selectivity Index of 426 (CC50=241μM/IC50=0.565μM).
· Brilacidin’s main mechanism appears to disrupt viral integrity and impact viral entry.
· Brilacidin and remdesivir exhibit excellent synergistic activity against SARS-CoV-2.
In a broader context, demonstration of Brilacidin’s direct antiviral activity against the SARS-CoV-2 virus, supports the drug’s unique 3-in-1 therapeutic potential—antiviral, anti-inflammatory, antimicrobial—to treat COVID-19 and its associated complications.
Given the safety and efficacy data already known about Brilacidin from pre-clinical and clinical studies utilizing multiple routes of administration, a Phase 2 clinical trial of intravenously-administered Brilacidin for COVID-19 is being planned, with a trial initiation targeted for the fourth quarter of calendar year 2020. The Company filed a pre-IND meeting request with the US FDA for the study of Brilacidin for the treatment of COVID-19. FDA feedback has been received and the Company is now finalizing the Phase 2 clinical protocol, and anticipates submitting a US IND application in November 2020 for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in COVID-19 hospitalized patients. Target enrollment is 120 patients. Contract Research Organizations have been secured to expedite trial enrollment, with many clinical sites expressing interest in participating in the study.
Partnering opportunities with industry and academic partners are ongoing regarding the COVID-19 program. The Company through discussions with industry, academic consultants, and potential partners will also explore investigation of treatment with Brilacidin by inhaled administration for the prevention of COVID-19 infection.
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