Sunday, July 22, 2018 1:23:12 PM
Re: cabel post# 186657 0
Post # of 235026
Hey cabel - prob closest I've seen is slide 12 in the Derm meeting presentation -- IGA scores / trends over time
http://www.cellceutix.com/s/Prurisol-Presentation-for-Med-Derm-RD-Workshop_19Sep2016-u.pdf
What's worth noting is 43% ITT and 55% PP achieved IGA 0 or IGA 1 -- "clear" or "almost clear" ... ie ~PASI
90s and better ... why I'm saying I'll be happy w PASI 75s equal to or better to Otezla (30%) but am really hoping we get into the PASI 90s (biologics turf)
re 2-pt drop equaling PASI 90 ... best way to think about it is (roughly)
IGA 0 = PASI 100
IGA 1 = PASI 90
IGA 2 = PASI 75
Etc
the at least 2-point reduction from baseline (whether IGA 3 or IGA 2) is to show enough improvement to merit a claim of real efficacy
1-pt improvement not good enough -- kind of like PASI 50s -- secondary efficacy and not considered by FDA sufficient to merit approval -- PASI 75 long been the bar and some now saying PASI 90s should be new bar
Kadmon has this challenge - only getting PASI 50s
CanFite thinks it can compete w Otezla (going head to head in a Ph 3 in Europe) but its drug takes forever to kick in, 20+ weeks
See below
https://goo.gl/images/RCizxy
Hopefully we eventually get to see Prurisol plotted against Otezla -- similarly to the CanFite data -- but with stronger results
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