Biotech Values

[willyw]

My comments on the G-1 trial;

I do not follow where you are getting 12 weeks?

The quote from the 1st cohort is;
"ABT-493 + ABT-530 (high dose) daily for up to 16 weeks".

The verbage is the same for the low dose cohort

I view this as meaning that rapid responders (lets say RVR....clear by week 4) may stop at 12 weeks, slower responders may go 16 weeks.

I see nothing that indicates the determining process, but I think this will be revealed in the trial agreement that people sign, and therefore it will be known fairly soon.
Anyway.... this is what I read and interpret.

I guess that I will mention the hi/low dose of 530 in this geno one discussion, although it may also be better discussed/questioned in the phase 2/3 trial.

It is of interest to me that they are still figuring out the 530, and yet they have had more dosings with 530 (in the small 450/ 530 trial earlier in the year)
They still don't quite seem to know, and also...there has been no other 493 dosing, and they seem set on that without any further testing.

To me this *seems* like it could be a efficacy or safety issue w/ 530, like they can't get efficacy without treading into safety issues. Or, it could be the notion of trying to pare a dose down into a smaller size so it could be co-formulated into one pill.... or making it smaller still so a third drug could be added. Or it could be something else, or three other things. : )

One thing to add here, and it is borrowed from a Vertex pitch, when they bought in the polymerase inhibitor that became VX-222. It was said that the log drops (viral decline) achieved in combining the two drugs (VX-222 and VX-950) would be "additive and synergistic".

The point is, they have not YET combined these two drugs. One really doesn't not know the synergistic effect that can be achieved. If these are an excellent match, nothing sneaks by them, the virus is eradicated before it can mutate around them.... in theory, and one's innate immune system mops up stragglers....and there are always stragglers.

We don't know if you are right about 12 weeks, or if the 16 week will be a thing, but.....
If the drug combo is successful perhaps all will be earlier responders, and therefore none may hit the 16 week maximum dosing period.

What we have seen in the past is that there has been little benefit in extending beyond 12 weeks with most/or all of these DAA's. Actually, if anything they do not want to dose beyond 12 weeks in the past for fear of creating stronger resistant subspecies populations/strains. So I don't know what to make of it.

I hope that we will see some decent talks about the 2nd generation program at AASLD.

I still have not really waded into the geno 2/3 trial yet. I was somewhat stumped about the 450/530 small trial earlier, but will try to confine discussion on that to a G-2/3 response reply so discussions don't become too broad in THIS reply.
~W