Innovation Pharmaceuticals Inc (IPIX)

[georgejjl]

The reason for the difference between the Per Protocol and Intenet to Treat groups from the previously completed Prurisol Phase 2a trial.

Overall analyses showed Prurisol, which is being developed under the FDA’s 505(b)(2) program, to be superior to placebo in the 200mg arm. Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.

Evaluating the primary endpoint at 84-days (week 12) in the 200mg arm, 35.0% of the patients receiving that dose of Prurisol demonstrated clinically significant improvements compared with 16.7% of patients on placebo only. This percentage includes patient data from one site where investigator non-compliance may have occurred. Were that site to have been excluded from overall data analysis, as is done in some clinical studies (refer to the journal article linked to below, published findings from another psoriasis study), 43.7% of patients in the 200mg Prurisol arm would have met the primary endpoint. Patient responses in the 50mg and 100mg arms were statistically comparable to the placebo arm.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4229025/

For purposes of direct comparison, the Prurisol trial outperformed a similarly designed Phase 2b trial in the treatment of mild to moderate psoriasis conducted in 2011 by Anacor Pharmaceuticals in which a topical anti-inflammatory compound was assessed. See the link below.

http://investor.anacor.com/releasedetail.cfm?releaseid=587511

Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower.

Good luck and GOD bless,

George