Replies to post #143262 on Innovation Pharmaceuticals Inc (IPIX)

[sox040713]

I found Leo's explanation to be satisfactory.

"Ehrlich explained that the company's confidence in Prurisol led to the decision to evaluate the drug under some of the most difficult situations, and that meant a short-duration study evaluating only one particular lesion in patients being treated with an oral drug (Prurisol). "It doesn't get much more difficult than that," Ehrlich said. "But, by going with a short study, we saved money, challenged our drug, and will have plenty of data for a late-stage trial."

Anyone else felt it's bogus?

[biodoc]

To Infinity.. we have different styles but I think you are raising a legitimate point. From Prurisol Phase 2

The primary efficacy endpoint will be the percentage of subjects with ≥ 2 point improvement in IGA rating as defined by visual inspections of patient lesions

IGA, if I understand correctly, describes disease severity and not a single lesion. I think Leo's comments need clarification.

[MinnieM]

Ok... I'll take a shot at the answer since I've taken a bit of time in reading it all over again. I thought of sending a note to Leo, but, decided not to bother him on a holiday weekend.

You and biodoc appear concerned about the company decision to target a specific lesion since most psoriasis studies don't do this. And, it appears in conflict with the primary outcome measure of the trial.

Leo's comment follows:

https://www.thelifesciencesreport.com/pub/na/16918?utm_source=delivra&utm_medium=email&utm_campaign=TLSR+final+3-14-16

Nearly all biotechs developing a psoriasis drug target the moderate-to-severe patient class, but not Cellceutix in its Phase 2 study. Ehrlich explained that the company's confidence in Prurisol led to the decision to evaluate the drug under some of the most difficult situations, and that meant a short-duration study evaluating only one particular lesion in patients being treated with an oral drug (Prurisol). "It doesn't get much more difficult than that," Ehrlich said. "But, by going with a short study, we saved money, challenged our drug, and will have plenty of data for a late-stage trial."

https://clinicaltrials.gov/ct2/show/NCT02494479?term=prurisol&rank=2

Primary Outcome Measures:
• The primary efficacy endpoint will be the percentage of subjects with ≥ 2 point improvement in IGA rating as defined by visual inspections of patient lesions [ Time Frame: 84 days ] [ Designated as safety issue: No ]

In looking back at the trial again and going beyond just the primary outcome I see the single lesion test in the secondary outcome measures. I don't believe this focus invalidates or takes away from the primary measure. I just think Leo was focusing on the secondary single lesion measures in the interview. I look forward to seeing top line data in May.