@ Kelt - I sent you a PM thinking I did not have t
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Posted On: 03/13/2021 10:59:43 PM
@ Kelt - I sent you a PM thinking I did not have time to look for it but then a short search found this.
From the February 13, 2020 PR:
“Serial blood samples were collected through 24 hours post-dose to assess absorption of oral Brilacidin from the colon. Blood level analysis, using a sensitive limit of quantitation in plasma of 1 ng/mL, demonstrated no quantifiable Brilacidin concentrations at any timepoint across treatment cohorts and shows containment of Brilacidin within the target location. (Confirmatory repeat plasma concentration analyses are ongoing to verify this finding).
Given Brilacidin has shown clinical efficacy with limited absorption in other clinical trials, in Ulcerative Proctitis/Ulcerative Proctosigmoiditis and Oral Mucositis, these results suggest oral Brilacidin for IBD might be safely dosed at even higher levels of drug via targeted release tablet.
Professor Howard Stevens, Principal Investigator for the study and Chairman of BDD Pharma, commented:
‘BDD are delighted to have successfully completed the first oral dosing study of Brilacidin, which has demonstrated the capability of its OralogiK™ Technology to deliver a Brilacidin formulation to the colon. The treatments were well-tolerated with no treatment related adverse events. Although absorption of Brilacidin was not observed from analysis of plasma concentrations, this was not unexpected and may indeed be a desirable attribute for a drug that acts by virtue of its local effect on inflamed mucosal surfaces within the lower GI tract. We look forward to further collaboration with Innovation Pharma as this exciting drug progresses through development.’ “
From the February 13, 2020 PR:
“Serial blood samples were collected through 24 hours post-dose to assess absorption of oral Brilacidin from the colon. Blood level analysis, using a sensitive limit of quantitation in plasma of 1 ng/mL, demonstrated no quantifiable Brilacidin concentrations at any timepoint across treatment cohorts and shows containment of Brilacidin within the target location. (Confirmatory repeat plasma concentration analyses are ongoing to verify this finding).
Given Brilacidin has shown clinical efficacy with limited absorption in other clinical trials, in Ulcerative Proctitis/Ulcerative Proctosigmoiditis and Oral Mucositis, these results suggest oral Brilacidin for IBD might be safely dosed at even higher levels of drug via targeted release tablet.
Professor Howard Stevens, Principal Investigator for the study and Chairman of BDD Pharma, commented:
‘BDD are delighted to have successfully completed the first oral dosing study of Brilacidin, which has demonstrated the capability of its OralogiK™ Technology to deliver a Brilacidin formulation to the colon. The treatments were well-tolerated with no treatment related adverse events. Although absorption of Brilacidin was not observed from analysis of plasma concentrations, this was not unexpected and may indeed be a desirable attribute for a drug that acts by virtue of its local effect on inflamed mucosal surfaces within the lower GI tract. We look forward to further collaboration with Innovation Pharma as this exciting drug progresses through development.’ “
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