Innovation Pharmaceuticals Inc (IPIX)

[TheHound]

Prurisol's ph 2 met the primary endpoint (a 2-point IGA reduction) in 35% of all patients who received a dose of 200mg per day. Had one site, where investigator non-compliance was suspected to have occurred been removed from overall data analyses, 43% of patients in the 200mg dosing arm would have met the primary endpoint. Among patients with the severest form of psoriasis studies, those having a baseline IGA score of 3 (“moderate”); the primary endpoint was met in 46% of patients who received 200mg per day. These data were derived from analyses of all patients. Patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point IGA improvement. Patients reported improved general skin condition, e.g., skin felt moist and smoother. Prurisol was well-tolerated – just one Serious Adverse Event (SAE) occurred and it was in the 50mg dose group. PK results showed a dose-dependent increase in exposure and maximum plasma concentration of the drug. The elimination half-life was similar in each of the three dosing levels (50mg, 100mg, 200mg), with an average of 1.3 hours. The clearance of the drug was also similar across dosing levels, with an average of 80.1 liters per hour. 12 week outperformed historical Investigator's Global Assessment (IGA) efficacy data of competing drug in pipeline (CF-101) and approved oral drug OTEZLA. Study was not powered to achieve statistical significance, instead designed to establish proof-of-concept.

https://drive.google.com/file/d/0Bz15O4eaX-asWVpoclB2WUhENFk/view