Posted On: 11/15/2016 10:54:34 AM
Post# of 72447
Brilacidin: stuff we already know..... works by insertion into bacterial membranes, also immunomodulatory.
QIDP fast track for ABSSSI. Also anti-inflammatory actions.
UP results exciting.
OM ongoing trial, interim analysis 1H 2017.
UP: sequential dose escalation. 6 in each cohort. Low dosing group 50 mg, will be 100 and 200 mg cohorts. MMDMI: 2 had 100% reduction, 2 more had notable improvement. Looking endoscopically, 1 had full reduction, 2 had notable reduction (Note: we know that one person with full response refused the endoscopy, that's why numbers don't seem to add up.)
Generally well-tolerated results. Drug concentrations in plasma were undetectable so it can be administered locally and not systemic exposure.
OM: ongoing Phase 2. 1H 2017 will be interim analysis. Trots out the hamster study again. 94% reduction in animals, should be the same for humans.
60 subjects: swish and spit 3x/day for 7 weeks. Hoping for delayed onset of OM, and if it does occur, hope for diminution of its effects.
Bril-ABSSSI: Comparator is Daptomycin. Bril is non-inferior. (old news so far)
Single dose comparable to Dapto for 7 days. QIDP from FDA.
Working on response for Special Protocol Assessment for FDA approval. Will design appropriate Phase 3 trial.
QIDP fast track for ABSSSI. Also anti-inflammatory actions.
UP results exciting.
OM ongoing trial, interim analysis 1H 2017.
UP: sequential dose escalation. 6 in each cohort. Low dosing group 50 mg, will be 100 and 200 mg cohorts. MMDMI: 2 had 100% reduction, 2 more had notable improvement. Looking endoscopically, 1 had full reduction, 2 had notable reduction (Note: we know that one person with full response refused the endoscopy, that's why numbers don't seem to add up.)
Generally well-tolerated results. Drug concentrations in plasma were undetectable so it can be administered locally and not systemic exposure.
OM: ongoing Phase 2. 1H 2017 will be interim analysis. Trots out the hamster study again. 94% reduction in animals, should be the same for humans.
60 subjects: swish and spit 3x/day for 7 weeks. Hoping for delayed onset of OM, and if it does occur, hope for diminution of its effects.
Bril-ABSSSI: Comparator is Daptomycin. Bril is non-inferior. (old news so far)
Single dose comparable to Dapto for 7 days. QIDP from FDA.
Working on response for Special Protocol Assessment for FDA approval. Will design appropriate Phase 3 trial.
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