An already started Phase 2b clinical trial of Prurisol as a treatment for moderate-to-severe chronic plaque psoriasis has recruited more than 70 percent of the 189 participants that researchers hoped for.
The therapy’s developer, Cellceutix Corporation, said it expects to release the trial’s initial results during the third quarter of 2017.
Prurisol is an oral immunomodulatory therapy that reduces the expression of an RNA molecule called PRINS whose function has yet to be determined. PRINS stands for Psoriasis susceptibility-related RNA Gene Induced by Stress. Expression is the process by which information from a gene is used to create a functional product like a protein.
Cellceutix is following a regulatory path that it hopes can accelerate Prurisol’s U.S. approval. The Federal Drug Administration allows a company to use long-term safety results of an approved drug that is similar to its own when it seeks its candidate’s approval. In this case, the drug is a Prurisol bioequivalent called Ziagen.
Researchers have completed a 12-week Phase 2 clinical trial (NCT02494479) of Prurisol in patients with mild-to-moderate chronic plaque psoriasis. Two Prurisol doses were tested, with the study showing that the higher one improved patients’ psoriasis. The therapy was also well tolerated, the trial showed.
The Phase 2b trial that Cellceutix is now conducting (NCT02949388) is randomized, double-blind, parallel-group and placebo-controlled. It is assessing the drug’s effectiveness at doses higher than the 200 mg per day that researchers found to be successful in the previous trial.
Researchers are testing doses of 300 and 400 mg per day in the new trial. Patients who are already enrolled are already receiving one of the two.
The team is using patients’ Psoriasis Area and Severity Index (PASI) scores at the start and finish of the 12-week testing period to evaluate Prurisol’s effectiveness.
The trial’s primary goal is a 75% reduction in PASI scores over the 12 weeks. An interim analysis of effectiveness will be done after six weeks.
The effectiveness of current psoriasis treatments diminishes over time, and the therapies have side effects.
Cellceutix expects Prurisol to prove safe and effective not only for chronic plaque psoriasis but also for psoriatic arthritis, rheumatoid arthritis and other conditions.