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Thursday, 11/13/2014 11:19:03 AM

Thursday, November 13, 2014 11:19:03 AM

Post# of 2976
Enanta CS stock presentation Nov 12

http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-calendar
(audio archived record and separate power point file)

Not much new, but it was confirmed that ABT-493 provided about a 4 log drop in various populations in various doses
mean maximal decline -3.8 to -4.3 log IU/mL (slide 16)

Rather insignificant viral kinetics between the 100 mg dose and the 700 mg dose

Of note; the cirrhotic group was administered 200 mg as well as a 200mg non-cirrhotic group. Both scored almost exactly the same rate of decline suggesting that 200 mg would work for harder to treat. Both ended up right in the middle range, suggesting that 200 mg might be the dosing size they will go with.

FWIW, the Harvoni pill is 400 mg. So an Abbvie 530 dose would need to be about 200 mg to be the exact same size as Harvoni at 1 pill per day.

I believe that the 530 doses were as follows;
ABT-530 (noncirrhotic: 15, 40, 120, or 400mg; cirrhotic: 120mg)
I believe the studies showed that w/ doses of 40mg and up the viral kinetics looked workable, so coming in under 400 mg certainly looks doable.

I do not yet have info on how that went, but we may soon hear, just as we did from Enanta. It was made public Nov 11 at the AASLD
(I believe the Abbvie compound ABT-530 hit about a maximal 4.5 log drop across doses, but...we will hear more later.

====================
I could not tell from Luly, but he made a point of addressing the newly re-acquired EDP-239. If this were an unusable/unviable compound based on data from the Novartis dosing, I would not have thought that Dr. Luly would have brought it up. If the viral kinetics, safety profile looked good, I wonder if it might get a sample cohort in an an upcoming 2nd gen trial. As a host targeted drug it would offer a different method of viral reduction, thus sidestepping resistance issues, be pan-genotypic, etc.

I just thought it was interesting it was brought up and seemed to get more mention than pumping the nuke candidate in the stable. To me it looks as though they may be interested in developing it (albeit based on the brief mention).

Luly mentioned 2nd gen time frame 2017-18, but it seems to me that both Abbvie and ENTA lean more towards being conservative and not over-promising.

note; some of this info came from AASLD abstracts, some from the CS Nov 12 pitch.
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