I am still hopeful that Compassionate Use (CU) res
Post# of 72447
(Total Views: 839)
Posted On: 11/13/2021 7:05:03 PM
I am still hopeful that Compassionate Use (CU) results will show some success. If CU does indeed show success, then a detailed evaluation of why CU was successful vs why the Phase 2 trial did not meet its endpoint needs to be done. If there were not any safety issues in either the trial or CU patients, it may very well be possible to increase either/both the daily dosage and the amount of days treated to determine if efficacy could indeed be shown as a differentiator in comparison to either the existing U.S. or Russian SOC.
It is obviously safe to say that the trial did not meet its primary endpoint goal of Sustained Recovery through Day 29, but I do not think it is correct to state that Brilacidin cannot be a valid treatment for any specific CV19 patient population. It could come down to a situation of increasing dosage and/or the number of days of treatment at the Moderate/Severe/Critical levels and/or using Brilacidin in combination with another drug or drugs.
Dr. DeGrado stated in the 11/12/21 PR “Given Brilacidin exerts antiviral activity prior to infection of cells, developing Brilacidin for potential prophylactic use by targeting the nasal passageway and lungs may be a particularly appealing clinical pathway.” Leo stated in the 11/11/21 PR “Initial feasibility work to formulate Brilacidin for potential prophylactic use via inhaled delivery, to leverage Brilacidin’s unique virucidal and blocking antiviral properties, also is underway. There are many paths to pursue in the antiviral space.” These statements will be interesting to monitor with an effort underway to develop a delivery system (inhaler?) for the mild CV19 patient population as well as for other viruses and infections.
There are still many paths available to advance Brilacidin for CV19 treatment, but we will have to see what comes out of a deeper dive that IPIX is researching from both the human trial and from CU data.
It is obviously safe to say that the trial did not meet its primary endpoint goal of Sustained Recovery through Day 29, but I do not think it is correct to state that Brilacidin cannot be a valid treatment for any specific CV19 patient population. It could come down to a situation of increasing dosage and/or the number of days of treatment at the Moderate/Severe/Critical levels and/or using Brilacidin in combination with another drug or drugs.
Dr. DeGrado stated in the 11/12/21 PR “Given Brilacidin exerts antiviral activity prior to infection of cells, developing Brilacidin for potential prophylactic use by targeting the nasal passageway and lungs may be a particularly appealing clinical pathway.” Leo stated in the 11/11/21 PR “Initial feasibility work to formulate Brilacidin for potential prophylactic use via inhaled delivery, to leverage Brilacidin’s unique virucidal and blocking antiviral properties, also is underway. There are many paths to pursue in the antiviral space.” These statements will be interesting to monitor with an effort underway to develop a delivery system (inhaler?) for the mild CV19 patient population as well as for other viruses and infections.
There are still many paths available to advance Brilacidin for CV19 treatment, but we will have to see what comes out of a deeper dive that IPIX is researching from both the human trial and from CU data.
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