let's talk about blood pressure(BP) . this comes up under AE for briliacidin in the Phase 2 trial, see jorgensen talk slide 20 of 24, and his explanation, ECC MID, to set the stage.
If anyone knows where there i more data I am glad to look at it . The slide shows that about 1/2 of 3 day dosing pts have incr BP. But we don't think that will be the dosing, so let's move on
At 0.6 one time dosing 2 pts or 3.8% had increased BP
At 0.8 it was 9 patients or 17%
Nota bene Daptomycin at 10%
I will say at outset I know nothing of drug trials.. But I know a lot about blood pressure. All day long every day I see people who are surprised at how high their BP is in the emergency dept. Not at all a surprise- they've cut a chunk out of their leg with a saw, or broken their wrist or hip, or done this or that. They very frequently comment that they have never had such high pressures. Does it affect them? No not at all. What is the downside of an elevated BP? Stroke or heart failure or heart attack, to take the major concerns. Does that happen in these every day, patient after patient, increases in BP? No, not at all.
So I do not worry in the least about the issue.
But, I will say that in terms of trials and how drugs are judged, that Jorgensen is clearly concerned about it. Maybe that was part of what sunk Polymedix- I do not know.
The details are nonexistent. What were the starting blood pressures? How long did they remain elevated? We are not told this info as far as I know.
We are told that it is an AE to have BP increase to above 160(systolic, the top number). I see no more
details- more than 180, or 200? Who knows? For 10 minutes? Or 10 hours? Or 10 days? Who knows? I will write to Jorgensen/Leo and ask and share my responses.
Note that they report no serious adverse events related to BP increases: no strokes and no heart attacks and no congestive heart failure. Just as you would expect. Some percentage of people will have their BP rise and it will have no important consequences.
I believe that clinically it is of no importance. In the world of drug trials I do not know. But Brilacidin single dosing is very unlikely to be much different than Daptomycin for the BP AE, and I think it is a non-issue.
Would I like more details? Yes, esp given Jorgensen's attn to the issue. Will they go with 0.7 in a single dose, or 0.8 or 0.6? We shall see. Worst case current data is 1 in 6 at 0.8 doing with some BP increase and no SAE.
This has me losing no sleep at all. And in fact it is close to bed time, work in the morning.
Again, I bow to those who might wish to amend / correct above remarks.
