Innovation Pharmaceuticals Inc (IPIX)

[Rdunn88]

P stats from MP Advisors... Nice report from the CTIX days.

http://www.mpadvisor.com/xyz/Cellceutix_160826.pdf


Prurisol – Clinical Development and Data in Psoriasis
CTIX-0001: Single-Dose, Crossover Pharmacokinetic and Bioequivalence Study Evaluating Oral Prurisol and Oral Abacavir Sulfate (Ziagen) in Healthy Volunteers.

Results: AUC values were comparable for both
Prurisol and Ziagen, (Figure 9) within 80% to
125% equivalence window, indicating equivalent systemic exposure. No serious adverse events or other significant adverse events occurred over the course of the study.

CTIX-0002 (Figure 10): A Ph2 trial of Prurisol in
patients with mild-to-moderate chronic plaque psoriasis
was completed in May 2016
•
Prurisol 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 (Figure 11).
•
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 Investig
ator's Global Assessment (IGA) efficacy
data of competing drug in pipeline (C
F-101) and approved oral drug OTEZLA
(Figure 12).
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