Not a med pro, but I understand the escalation is being used to test the delivery method for safety and seeing if any severe reaction to the drug vs the placebo is observed. The gamma scintigraphy evaluates each escalation dose for site delivery effectiveness. The results of those scintigraphies will be released a few weeks after the close of trial.
I think it indicates the safety and tolerance are definitely working. Not sure of the delivery to the colon, not sure if Gamma scintigraphy is performed after each cohort
Issue is the sample size simply won’t be large enough to make ANY assumptions, positive or negative.
If the cohorts were 30 people, perhaps. But 3 people just isn’t enough. It also DRASTICALLY can alter the perceived results, both falsely positively as well as negatively.
Just a terrible trial design, and I’m saying this as a multi-year long and believer in IPIX.