Enanta Pharmaceuticals Inc (ENTA)

[willyw]

AASLD Abbvie/ENTA 2nd gen program presentations

Pharmacokinetics and Safety of Pan-Genotypic, Direct Acting Protease Inhibitor, ABT-493, and NS5A Inhibitor, ABT-530, Following 3 Day Monotherapy in HCV Genotype-1 Infected Subjects With or Without Compensated Cirrhosis uubn

http://www.natap.org/2014/AASLD/AASLD_52.htm

also.....


A Next Generation HCV DAA Combination: Potent, Pangenotypic Inhibitors ABT-493 and ABT-530 With High Barriers to Resistance

http://www.natap.org/2014/AASLD/AASLD_51.htm

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I have not had a lot of time to pour over these, but to me this looks like pretty good news.

Keeping in mind, there were only about 8 patients per cohort, so we cannot take the results too much to heart, but the *appearance* is that the kinds of responses seem dose dependent, kind of what you would expect, not leading one to suppose that that healthies ended up in one cohort and the sicker in another.
It appears that the harder to treat patients responded nearly as well as the less sick. Also encouraging.

I have not spent a lot of time on it, but *IF* the mean viral load was about 6.8 mill/IU/mL ......
and the viral load reduction was
about 4 log for ABT-493 (in 3 days)
and 4.5 log for ABT-530 (in 3 days)

.....anyway, in a week, it may very well be able to knock viral loads down to undetected, or thereabouts, depending on how well matched the compounds are, synergistic behavior, or if there are any holes in the defense. : )

Since they started dosing in September, Abbvie should have a pretty good handle on this by now, roughly 8 weeks into trials. By New Years day some people presumably will have stopped dosing.

Figure 6 slide shows about a 6 log drop *in vitro* reduction with the two compounds in combination;
roughly a 6 log drop in 3 days.

This is part of the key; destroy the viral load before it can mutate around the treatment.

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Getting back to the question of dosing, if it were so that 200 mg of ABT 493 was sufficient, from the slides it would appear that 100-120 mg of ABT-530 would be sufficient, bringing the pill size to 300ish mg. One pill once per day. (I believe a single Harvoni capsule is 490 mg)

I have no idea what dosages they are using in the phase 2b trials, but it looks to me as though 1 pill, once per day looks quite possible. There may even be room to add a 3rd compound and still be in one capsule.

I thought I would just get this out there and see what you think.
~W