Replies to post #225518 on Innovation Pharmaceuticals Inc (IPIX)

[biodoc]

CanesNH, you're making an important point that I've alluded to in the past. PASI-75 indicates degree of resolution of psoriatic plaques. About 70% of plaque psoriasis patients complain of itch which has been described as oftentimes biting and burning. Itching/burning is a major problem in plaque psoriasis and the usual anti-pruritics are simply not effective for this condition.

The name Prurisol, which contains the prur- root meaning itching, presumably provides insight into Menon's lab observations, hence the name. Though PASI-75 is the primary endpoint and is a clear marker for resolution of plaque disease, psoriasis sufferers would happily greet a well tolerated oral medicine that greatly reduces itching (and the associated burning/biting pain). Big Pharma marketing arms are not blind to this potential.

Hopefully, PASI-75 (12 weeks) will be pretty good (>25%) with a high single digit placebo rate but a lower PASI-75 with most patients getting notable relief from life-impacting symptoms and at least some plaque clearing will still be extremely valuable. This trial is more complex that just PASI-75 and anyone who understands the disease and the limitations of current treatments will understand that.

Phase 2b is an effort to dial in optimal dosing and gain a better understanding of the strengths and limitations of Prurisol. Convincing data for any of the primary or secondary outcome measures from this Phase 2b will hopefully provide the basis for a well designed Phase 3 within the 505(b)2 pathway which greatly increases the odds of eventual drug approval. This approach may allow for reduced time to market and much lower development costs. The detailed Phase 2b with multiple associated surveys along with the designated 505(b)2 pathway adds immense value to an acquirer with greatly reduced risk and fewer unanswered questions. It makes total sense that itch severity, quality of life, patient satisfaction, and health quality surveys are part of this complex study.

Eagerly awaiting data.
biodoc

[kfcyahoo]

CanesNH,

Excellent response.

However, I suspect the questionnaires resulted from this fda meeting, held on 3/17/16(St. Paddy's day), to get input from psoriasis patients and the general public who have experience with psoriasis, but have also thought along your line of thinking.

I found the link below last night and will have to listen in intermittently(I'm only as far as the 1st hour into the first recording- meeting ran from ~ 9 or 10 to 4).

I recommend pumpers and bashers, and those honestly frustrated, listen to it.


https://collaboration.fda.gov/p9l99v4eycu/?launcher=false&fcsContent=true&pbMode=normal