Asked an experienced professional who recently returned to the other site some questions regarding the pill formulation for both Kevetrin and Brilacidin. Here is his reply - I think it is pretty good info and appears to me that Kevetrin pill could possibly be going into conjugate trials much earlier than I was expecting and the same goes for Brilacidin pill. All we really need is the funds to get them on track.
Hey Pete, from my experience, most of the "toxicology testing" is working out the pharmacokinetics of the oral formulation. These differ from the IV formulation due to first pass effect, bioavailability, elimination characteristics etc.... The dosage you refer to will be based on these characteristics. Once the kinetics of the oral formulation are worked out, which should not take that long, I would not think that a separate trial to determine the safety of the pill formulation would be necessitated and could go directly into conjugate trials given that the downstream biomarker levels is similar. B is different in that it is largely not bioavailable orally such that the pharmacokinetics would be much simpler. Hope that helps
Hey Pete, from my experience, most of the "toxicology testing" is working out the pharmacokinetics of the oral formulation. These differ from the IV formulation due to first pass effect, bioavailability, elimination characteristics etc.... The dosage you refer to will be based on these characteristics. Once the kinetics of the oral formulation are worked out, which should not take that long, I would not think that a separate trial to determine the safety of the pill formulation would be necessitated and could go directly into conjugate trials given that the downstream biomarker levels is similar. B is different in that it is largely not bioavailable orally such that the pharmacokinetics would be much simpler. Hope that helps
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