US-based clinical stage biopharmaceutical company Cellceutix has begun its Phase IIb clinical trial of Prurisol to treat moderate-to-severe chronic plaque psoriasis.
Psoriasis is a chronic, immune-mediated skin disorder characterised by raised and inflamed skin on the elbows, knees, scalp, hands and feet, causing itching, irritation, stinging and pain.
The randomised, double-blind, parallel-group, placebo-controlled study is expected to involve approximately 189 patients and has started screening patients.
Patients will be randomised on a 3:1:3 basis to be administered with Prurisol and placebo for a duration of 12 weeks.
The study is primarily focused on determining the efficacy of Prurisol, which will be determined on the basis of Psoriasis Area and Severity Index (PASI), enabling a more direct comparison to already approved psoriasis drugs.
The secondary endpoints of the study are to find out the potential benefits of Prurisol compared to marketed therapies, both oral and biologic.
Cellceutix president and chief medical officer Arthur Bertolino said: “The start of this study is a key milestone for our psoriasis programme, bringing us closer to the Phase III registration programme, and its results will further build upon the positive Phase II data reported earlier this year.
“A new oral drug that delivers substantial efficacy, expanding choices for treatment, should command considerable market value and add value for our shareholders.”
An interim analysis of a six-week data from this trial is expected to be released in the second quarter of next year.
Acting through immune modulation and PRINS reduction, Prurisol is a dermatology compound currently in mid-stage development as an oral psoriasis treatment.
Image: Psoriasis on toenails. Photo: courtesy of JVO27/Wikipedia.