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Posted On: 09/03/2021 6:38:31 PM
Post# of 72440
The paragraph that you highlighted below IMO had 2 very important objectives. One was to determine Brilacidin’s Selectivity Index which helps to determine a drug’s safety profile and effectiveness. The second objective was to use this testing to validate and optimize dosage levels and frequency to be used in human CV19 trials. In the B-ABSSSI phase 2, Brilacidin was a 1 dose IV treatment protocol. One of the exciting things about the B-CV19 human trial was a 3 day dose treatment on the first 25% (30 or so patients) and after an extensive 3 week DMC review, a green light approval to expand the remaining 75% (90 or so patients) to a 5 day dose regiment. This highlights the safety profile of Brilacidin for CV19 and is consistent with the safety profile that was proven in prior Brilacidin FDA trials for B-ABSSSI, B-IBD UPS and B-OM using 3 different delivery mechanisms.
The selectivity index (SI) is a ratio that measures the window between cytotoxicity and antiviral activity by dividing the given AVA value into the TOX value (AVA/TOX).
From ScienceDirect “Selectivity index (SI) can be defined as the ratio of the toxic concentration of a sample against its effective bioactive concentration [56]. The ideal drug should have a relatively high toxic concentration but with a very low active concentration.”
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From 7/20/20 IPIX PR
“Additional RBL testing will assess Brilacidin’s inhibition against SARS-CoV-2 in the human lung epithelial cell line at even lower concentrations to allow for accurate determination of Brilacidin IC50 and IC90 values—the drug concentration at which 50 percent and 90 percent of the virus is inhibited. IC90 rather than IC50 values are considered valuable measures of drug potency as they are more likely to reflect in vitro results translating to comparable results in humans.”
From 8/24/20 IPIX PR
“In a new experiment at the RBL in a human lung epithelial cell line, Brilacidin, when directly incubated with the live (or wild type) virus, was shown to inhibit the virus by 50 percent (the IC50 value) at a mid-nanomolar concentration, while remaining non-cytotoxic to cells at high micromolar concentrations—establishing a SI for Brilacidin greater than 300 in this lung cell line. Additionally, this new testing in the human lung cell line showed Brilacidin’s IC90 value to be in the low micromolar range.”
The selectivity index (SI) is a ratio that measures the window between cytotoxicity and antiviral activity by dividing the given AVA value into the TOX value (AVA/TOX).
From ScienceDirect “Selectivity index (SI) can be defined as the ratio of the toxic concentration of a sample against its effective bioactive concentration [56]. The ideal drug should have a relatively high toxic concentration but with a very low active concentration.”
===========================================================
From 7/20/20 IPIX PR
“Additional RBL testing will assess Brilacidin’s inhibition against SARS-CoV-2 in the human lung epithelial cell line at even lower concentrations to allow for accurate determination of Brilacidin IC50 and IC90 values—the drug concentration at which 50 percent and 90 percent of the virus is inhibited. IC90 rather than IC50 values are considered valuable measures of drug potency as they are more likely to reflect in vitro results translating to comparable results in humans.”
From 8/24/20 IPIX PR
“In a new experiment at the RBL in a human lung epithelial cell line, Brilacidin, when directly incubated with the live (or wild type) virus, was shown to inhibit the virus by 50 percent (the IC50 value) at a mid-nanomolar concentration, while remaining non-cytotoxic to cells at high micromolar concentrations—establishing a SI for Brilacidin greater than 300 in this lung cell line. Additionally, this new testing in the human lung cell line showed Brilacidin’s IC90 value to be in the low micromolar range.”
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