Sunday, July 28, 2019 6:56:30 AM
There was. And the results were very good. But it included only 18 patients with final results for 17 of them. 3 different dosages in enemas all produced positive results but no clear winner in terms of dosage.
"Alpha will run a phase 2, but it will be a, 2b and likely with the improved B foam or some other retention medium"
Are you saying that the 2b will be used to determine medium AND dosage, using multiple cohorts of both? (Or would they select a medium without any formal clinical testing to determine their relative effectiveness?) How many patients might a P2 require given those variables?
Thanks for pitching in. The point may have been more specifically that whether 2a or 2b, Alfa isn't in a position to go straight to a Phase 3 trial, which would then trigger the first development payment. In case that was the point it's clearly true, isn't it?
ps. There seemed to be an anomaly in the retention times per the table in the poster.
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5beac1250ebbe846eb4b031e/1542111528589/IPI+IBD+Innovate+2018+Poster+%28final%29.pdf
The colorful table shows it better, but it says:
5 out of 6 patients in cohort A (50mg) and 3 out of 5 patients in cohort C (200mg) held on for over 4 hours.
But 4 out of 6 patients in cohort B (100mg) rushed the exit in 30 minutes to an hour.
Brilacidin obviously didn't cause that so either there was some inconsistency in the medium or some other explanation seems to be in order. In spite of the small sample size the Table makes the inconsistency somewhat obvious.
The results are obviously more consistent, but in terms of medium selection I would think that inconsistency could create questions, wouldn't you?
But can it core A apple?
Yes Ralph, of course it can core A apple.
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