BEVERLY, MA – June 29, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces database lock for its Phase 2b clinical trial of oral Prurisol in moderate-to-severe chronic plaque psoriasis. Prurisol is being developed as a novel, nonbiologic, orally-delivered psoriasis drug candidate.
“Locking the database is a key step toward analyzing data from our randomized, placebo-controlled trial of Prurisol, one of the larger studies we’ve conducted to date,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We are excited to have reached this milestone and will now move to process trial data and report topline study results. Psoriasis is a large market for which new treatments, particularly oral medications, are highly sought after by providers and patients.”
A total of 199 patients were randomized in the clinical trial (see NCT02949388), which included: a screening period of up to 4 weeks; a treatment period of 12 weeks; and a follow-up visit after 4 weeks off-treatment. The randomized, double-blind, parallel-group and placebo-controlled study increased 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). Efficacy evaluation includes the Psoriasis Area and Severity Index (PASI) and a Physician Global Assessment.