Phase 2 Trial of Prurisol for Psoriasis to be Unblinded, Promising Result Expected

Phase 2 Trial of Prurisol for Psoriasis to be Unblinded, Promising Result Expected

Cellceutix Corporation recently announced that the clinical database for the phase 2 clinical trial of Prurisol, for treatment of mild-to-moderate chronic plaque psoriasis,  will be ‘unblinded’ within the next few days.

Based in Beverly, Mass., Cellceutix Corporation is a clinical-stage biopharma company that develops novel therapies with oncologic, dermatologic, anti-inflammatory and antibiotic applications. Chronic plaque psoriasis is a skin disease that causes an inflammatory reaction with outbreaks of red, scaly patches than can appear anywhere on the body.

Removing the ‘blind’ will allow data from each of the four arms of the trial to be reviewed and analyzed in order to evaluate the safety and efficacy of the drug candidate. The four arms included: one placebo given twice-daily for 84 days; one 50 mg tablet of Prurisol and one matching placebo in the morning plus two placebo tablets in the evening for 84 days;  one 50 mg tablet of Prurisol and one matching placebo twice-daily for 84 days; or two 50 mg tablets of Prurisol given twice-daily for 84 days. All arms were delivered orally.

Cellceutix is expecting top-line data from the randomized, double-blind, parallel-group, and placebo-controlled clinical study of the efficacy and safety of Prurisol in patients with mild to moderate symptoms of the chronic skin disease. Results of the study will likely be released one week after the blind is removed.

Prurisol™ is Cellceutix’s anti-psoriasis drug candidate — a small molecule (MW=344) that acts through immune modulation and psoriasis-associated RNA induced by stress reduction. Prurisol has already shown effective against psoriasis in animals with induced psoriasis or those applied with xenografts of human psoriatic tissue.

Also in the company’s dermatology pipeline is a request for a pre-investigational meeting with the U.S. Food and Drug Administration to discuss future clinical research for Brilacidin, Cellceutix’s lead defensin memetic, an antibiotic modeled after front-line defense proteins in the human immune system. Brilacidin may be used to treat the inflammatory skin conditon hidragenitis suppurativa. The company anticipates meeting with the FDA in June to submit details of the planned trial.


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