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news.Isotechnika has obtained encouraging preliminary 48-week clinical safety data from its phase III psoriasis and extension trials for its lead immunosuppressive drug, ISA247.
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Patients completing the 24-week Canadian phase III trial, named SPIRIT, were given the opportunity to continue therapy for an additional 36 weeks or to discontinue therapy. Those patients who chose to enroll in the extension trial were moved from the 0.2mg/kg bid (low dose) or 0.4mg/kg bid (high dose) groups into the 0.3mg/kg bid (mid dose) group. Patients who commenced the SPIRIT trial in the 0.3mg/kg bid dose group remained on the same dosage regimen for the duration of the extension trial.
The goal of the extension trial is to demonstrate continued therapeutic benefit to psoriasis patients while gathering long-term safety data.
To date, data has been received on 193 patients receiving treatment for a total of 48 weeks. Patients previously in the low-dose group experienced an improvement in mean percent decrease in psoriasis area and severity index (PASI) scores from baseline of 41% to 64% after an additional 24 weeks on the mid dose. Patients previously in the mid and high-dose groups remained stable with mean percent decrease from baseline PASI scores of 61% and 66% respectively after a total of 48 weeks of treatment.
Of the total patient population, 4.4% (9 patients in the SPIRIT trial and 11 patients in the extension trial), showed a clinically significant change in kidney function. There have been no clinically significant changes noted during the extension trial in any of the other safety parameters monitored including cholesterol, triglycerides, new onset diabetes and infectious complications.
“We are pleased that the extension data shows continued efficacy and safety of ISA247. The number of patients experiencing a clinically significant reduction in kidney function is significantly less than with other calcineurin inhibitors such as cyclosporine where the incidence is at least 20%,” commented Dr Randall Yatscoff, Isotechnika’s president & CEO.
“In addition, the absence of any clinically significant changes in lipids, glucose and blood pressure levels, along with the absence of significant infectious complications, supports the long-term safety of ISA247 administration,” he continued.