10K data featuring Remdisavir & Brilacidin (Humm
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Posted On: 09/28/2021 6:22:44 AM
10K data featuring Remdisavir & Brilacidin
(Hummm, shades of Gilead Batman )
On page 10 & 11 find:
…Due to the global COVID-19 pandemic, the Company was approached by a number of organizations to research Brilacidin against the novel coronavirus (COVID-19). 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 demonstrated that Brilacidin exerts potent inhibition of SARS-CoV-2 and thus supported Brilacidin as a promising COVID-19 drug candidate for clinical studies. Also of note, Brilacidin in these research studies demonstrated excellent synergistic antiviral activity when combined with Remdesivir, a broad-spectrum antiviral medication.
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.
( C: note the Remdisavir comments I’ve put in bold print. IMO, Mr Ehrlich is possibly / intentionally flirting with Gilead. But I could be wrong ish ,,, nahhh he’s flirting lol - I hope he has a keen sense of humor. )
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.
A Phase 2 clinical trial of intravenously-administered Brilacidin for COVID-19 has achieved full enrollment (n=120) in sites in the United States and Russa. The Company is now preparing for study unblinding, statistical analysis and reporting of data. The study is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in COVID-19 hospitalized patients. The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes (e.g., duration of hospitalization, time to discharge), all-cause mortality, measurement of disease biomarkers (e.g., CRP, ferritin) and inflammation-related biomarkers (e.g., IL-1β, IL-6, IL-10, total IL-18, TNF-α), changes to SARS-CoV-2 viral load, as well as other key measures.
In April 2021, the clinical trial’s independent DMC completed its scheduled review of interim safety data. Upon reaching 25 percent enrollment (30 subjects), recruitment was paused and a pre-specified unblinded safety data review and evaluation was conducted by the DMC. The DMC recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, as intended per the protocol, which the Company implemented. In July 2021, the independent DMC completed a second review of interim safety data; based on their review, the DMC agreed to recommend the trial continue with no further modifications to the protocol.
The Company is collaborating with a Regional Biocontainment Laboratory researcher investigating further research opportunities with Brilacidin as a treatment for the SARS-CoV-2 virus, other Human Coronaviruses (H-CoVs), and other types of viruses.
( C: this is 98% most likely GMU BioDefence dept - which is a goer for the Military “wink wink nudge nudge know what I mean)
Further, grant applications for federally-funded research are pending, and further grant applications are planned.
(Hummm, shades of Gilead Batman )
On page 10 & 11 find:
…Due to the global COVID-19 pandemic, the Company was approached by a number of organizations to research Brilacidin against the novel coronavirus (COVID-19). 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 demonstrated that Brilacidin exerts potent inhibition of SARS-CoV-2 and thus supported Brilacidin as a promising COVID-19 drug candidate for clinical studies. Also of note, Brilacidin in these research studies demonstrated excellent synergistic antiviral activity when combined with Remdesivir, a broad-spectrum antiviral medication.
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.
( C: note the Remdisavir comments I’ve put in bold print. IMO, Mr Ehrlich is possibly / intentionally flirting with Gilead. But I could be wrong ish ,,, nahhh he’s flirting lol - I hope he has a keen sense of humor. )
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.
A Phase 2 clinical trial of intravenously-administered Brilacidin for COVID-19 has achieved full enrollment (n=120) in sites in the United States and Russa. The Company is now preparing for study unblinding, statistical analysis and reporting of data. The study is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in COVID-19 hospitalized patients. The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes (e.g., duration of hospitalization, time to discharge), all-cause mortality, measurement of disease biomarkers (e.g., CRP, ferritin) and inflammation-related biomarkers (e.g., IL-1β, IL-6, IL-10, total IL-18, TNF-α), changes to SARS-CoV-2 viral load, as well as other key measures.
In April 2021, the clinical trial’s independent DMC completed its scheduled review of interim safety data. Upon reaching 25 percent enrollment (30 subjects), recruitment was paused and a pre-specified unblinded safety data review and evaluation was conducted by the DMC. The DMC recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, as intended per the protocol, which the Company implemented. In July 2021, the independent DMC completed a second review of interim safety data; based on their review, the DMC agreed to recommend the trial continue with no further modifications to the protocol.
The Company is collaborating with a Regional Biocontainment Laboratory researcher investigating further research opportunities with Brilacidin as a treatment for the SARS-CoV-2 virus, other Human Coronaviruses (H-CoVs), and other types of viruses.
( C: this is 98% most likely GMU BioDefence dept - which is a goer for the Military “wink wink nudge nudge know what I mean)
Further, grant applications for federally-funded research are pending, and further grant applications are planned.
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Ronald A Phillips
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