The Prurisol Phase 2b trial has been designed to be powered for statistical significance.
Innovation Pharmaceuticals Completes Full Patient Enrollment in Phase 2b Study of Prurisol for the Oral Treatment of Psoriasis
BEVERLY, Mass., Aug. 28, 2017 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals Inc., (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces that it has met the goal of 189 patients enrolled in its ongoingPhase 2b clinical study of Prurisol for the treatment of moderate-to-severe psoriasis. The final number of patients will be up to 199, including those awaiting final screening test results through the end of this week (September 1). Based upon the protocol for 12 weeks of Prurisol treatment and additional patient follow-up for 4 weeks, the study is expected to be completed in Q4 2017, with results to follow thereafter. Prurisol is being developed as a novel, non-biologic, orally-delivered psoriasis drug candidate.
Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals, commented, “The anticipated completion of the Prurisol trial in 2017, in combination with the expected Q4 completion of the Phase 2 trial of Brilacidin-OM for preventing and treating oral mucositis in chemoradiation patients, are significant milestones for the Company and its shareholders. There is a large need in psoriasis treatment for novel therapies, particularly those that are non-biologic and orally-dosed, and which can provide a safe, early, and sustained control of this common and debilitating skin disease. Regarding Brilacidin-OM for Head and Neck Cancer patients being treated with chemoradiation, presently there is no FDA approved drug for preventing severe oral mucositis, a very painful and debilitating disease.”
The randomized, double-blind, parallel-group and placebo-controlled study (see NCT02949388) increases the total daily oral dosing of Prurisol from a previous high of 200 mg, which earlier was shown to be well-tolerated and demonstrated early efficacy, to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization). Enrolling, in total, approximately 189 patients with moderate-to-severe chronic plaque psoriasis, treatment duration is 12 weeks. Efficacy is being evaluated using the Psoriasis Area and Severity Index (PASI). Innovation Pharmaceuticals believes now is an opportune time to develop an oral treatment for psoriasis. Currently approved treatments, including injectable biologics, are limited, with many options costly, not easily administered, associated with undesirable side effects and/or diminishing effectiveness over time. A novel psoriasis drug, particularly one that is oral, safe and effective, which could expand patient and physician choices for treatment, likely would command significant market value. http://www.ipharminc.com/press-release/2017/8/28/innovation-pharmaceuticals-completes-full-patient-enrollment-in-phase-2b-study-of-prurisol-for-the-oral-treatment-of-psoriasis
Good luck and GOD