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biodoc

02/19/18 10:29 PM

#218068 RE: DaubersUP #218064

PASI-75 over 25% with a single digit placebo rate is competitive and deal-worthy. Of course, I'm hoping for much better but PASI-75 isn't the only consideration for a viable treatment.

In the Phase 2b trial design, PASI-75 is one of two primary outcome measures. The list of secondary outcome measures is lengthy and includes
(1) proportion of patients achieving sPGA score of 0 or 1 with at least a 2 point reduction from baseline
(2) change in baseline from patient reported itch severity
(3) assessment of patient reported quality of life (DLQI) and Short Form 36 Health Survey
(4) Assessment of health status by EQ-5D
(5) Assessment of patient satisfaction

I'll also be curious to see PASI-50 data which may provide a greater depth of understanding of the strengths and limitations of Prurisol as dosed. (What if almost everyone achieves PASI-50 but only 20% achieve PASI-75? Is it viable?). Outstanding itch relief by itself could set up for a very different type of Phase 3 trial.

This could play out in so many different ways and anyone who thinks they know what we're gonna see is fooling themselves.

biodoc