Replies to post #74731 on Biotech Values

[ghmm]

INFORM-1:

Some added perspective on the abstract.
#msg-33270341 contains the abstract of the 1B monotherapy results of 191. The cohort of most relevance to the abstract is:
2 (naïve) 100 mg q8h 8 -1.7

From Pharmassets presentations I couldn't find a BID 500mg in treatment naive's (http://www.pharmasset.com/pipeline/R7128-publications.asp) However here are some other measures of interest:
http://www.pharmasset.com/download/VRUS-R7128-HCVDrugDiscovery-CHI-042828.pdf slide 21 or http://www.pharmasset.com/download/R7128-ComboCohorts1and2-McHutchison-EASL-042508.pdf slide 8
The difference from the PEG arm appears to be around ~1.25 log (visual inspection so VERY rough)

http://www.pharmasset.com/download/R7128-Phase1-McHutchison-HEPDART2007.pdf slide 12 at 750mg BID in treatment failure around .75 log drop (again visual so very rough).

The INFORM results presented of note is Group C (100mg q8 191 and 500mg BID 7128) with results presented as:
the mean (SD [range]) change from baseline was -3.9 (0.8 [-5.0 to -2.9]) Log10 IU/mL, with 1 patient undetectable

Of note R7128 had much greater efficacy when dosing is at 1000mg BID and 191 at the 200mg dose which is planned to be tested in INFORM-1 (cohort D/Group F) had about a 2 log better performance then the 100mg q8 dose
4 (naïve) 200 mg q8h 8 -3.8

So in summary the synergy is very encouraging thus far. Of course the main concern was safety and if the combination would be tolerable and no mention of problems thus far.