A phase 2 study would be safety and optimization for Brilacidin with a drug already optimized and approved. So, with such a low number of patients, 127 if I remember correctly, the study won’t leave much room for much more escalation than a low and higher dose. It doesn’t take much B to trigger adverse events, while peak efficacy against several bacterial infections is significantly less than the adverse event threshold. So, the first combo cohort is likely look for conflicts between the two drugs, then the next cohort will have a little higher dose.
Again if I recall correctly, in the MRSA Phase IIb the doses were 0.6mg/kg, 0.8mg/kg, and 1.2mg/kg. I would suspect there is already some idea to start with something like 0.6mg/kg and then 0.8mg/kg. But, what do I know? It’s unlikely that the protocol will use anything but the already approved Remdesivir dosing.
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