Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

“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?”

Dosage and safety isn’t an issue since there is almost no absorption. For those 18 patients, efficacy and safety are already well established. Really, it’s just a matter of tweaking dosage and exposure to see if efficacy can be maximized. As for medium and delivery, there are well-established emulgents that require minimal testing. It’s really just a matter of picking the most convenient and easily applied, and then running with that. As for patients, I would think fewer than 300, perhaps as few as 100 if the plan is a phase 3. I would think that AS is in a position to argue safety sufficient to allow Phase 2/3 in Europe. Far less likely that same approval in the US.

Yes, there seems to be a corresponding B concentration and retention, but there is also a signal for increased concentration and efficacy. Cohort C approached 100% no RB more quickly than either of the other cohorts. However, 3rd week results give me pause as C drops back to 20% no RB from 60% the week before. Don’t know what that means. Just the same, no RB in 100% of subjects at week 7 for both B and C cohorts should mean accelerated trials. Again, AS is in a position to argue successfully for a BTD.

To your last question, I think it’s less of an issue than one might think. We are talking about retention enemas, which have been around for decades, if not centuries. We aren’t talking about time release capsules targeting specific regions of the upper and lower gastrointestinal tracts.