Isotechnika reports encouraging phase III psoriasis data

The phase III psoriasis trial, named SPIRIT, which commenced in December 2004, includes a total of 453 patients with stable moderate to severe plaque psoriasis. The trial is currently being conducted in 32 sites and is the largest of its kind in Canada using an orally administered systemic medication in psoriasis. The trial’s primary endpoint being investigated is the number of patients achieving a 75% decrease in the psoriasis area and severity index (PASI) score at 12 weeks.

Based on blinded data from 200 patients treated with either ISA247 or placebo for at least 12 weeks, PASI scores were, on average, reduced and were comparable to those observed in the company’s previous phase II trial. A clinical response in the current trial, as determined by PASI scores, has been shown in patients as early as four weeks after starting therapy.

In addition to evaluating the drug’s efficacy and overall safety, Isotechnika is monitoring kidney function in the trial as ISA247 belongs to a class of drugs, as ‘calcineurin inhibitors’, that have been associated with significant negative effects on kidney function.