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12/06/17 2:17 PM

#206489 RE: PlentyParanoid #206468

Pretty sure this analysis is incorrect:

at least 30 % (from 20/65) of IGA 3 subjects improved to IGA 0/1



and didn't really follow the rest, either.

First, there are only 20 subjects in the 200 mg PP population, not 65. 18 of the 27 200 mg ITT were IGA 3, and 9 IGA 2. We don't know for sure how many were IGA 3 in the PP, but based on the "46.2%" number given, we can assume that was 6/13 with IGA 3 in PP had an improvement to IGA 0 or 1 (a >=2 point improvement on IGA, i.e. the primary endpoint), and 1/7 with IGA 2 (went to 0) at 200 mg dose.

https://globenewswire.com/news-release/2016/05/26/955499/0/en/Cellceutix-Provides-Additional-Insight-Into-Successful-Phase-2-Trial-for-Treating-Psoriasis.html

Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 ("moderate"), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg.



Overall, then, 6/13 is the maximum responder rate in the IGA 3 PP group, and so 6/18 in the IGA 3 ITT group at 200 mg responded.

The sample size is very small. Lets hope this ~30-40% response rate is duplicated in a larger sample (Phase IIb) and at larger doses. If so, we should have another $1B drug on our hands, with sales similar to oral apremilast / Otezla.