Cellceutix’s phase 2 trial of Prurisol to treat mild to moderate psoriasis meets primary endpoint

A total 115 patients were enrolled in the placebo-controlled, randomized, double-blind trial, which evaluated the efficacy and safety of three separate, twice-daily, dosing regimens of Prurisol — 50 milligram (mg) (50mg QD), 100mg (50mg BD), and 200mg (100mg BD).

Clinical efficacy was demonstrated in the 200mg comparator arm and the compound shown to be safe and well-tolerated with a dose-related response.

The primary endpoint evaluated was the percentage of patients achieving at least a 2-point improvement from baseline on the 5-point Investigator’s Global Assessment (IGA) scale as measured by visual inspection of patient lesions at the end of the 84-day treatment period.

Cellceutix believes that the results are extremely encouraging, particularly for the 80% of psoriasis sufferers exhibiting milder symptoms of the condition.

The company intends to explore Prurisol’s potential to treat moderate to severe psoriasis and eczema, a skin condition experienced by about 30% of children and 10% of adults.

Prurisol is a small molecule that acts via immune modulation and PRINS reduction. A phase 2 trial has been completed under the US Food and Drug Administration’s 505(b)(2) pathway.

In laboratory trials, Prurisol was identified to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue.

Prurisol removed all indications of psoriasis with no reoccurrence of the lesions. It is synthesized via a five-step process using commercially available starting materials.