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Home » ISOTECHNIKA REPORTS FINAL DATA FROM PSORIASIS STUDY
ISOTECHNIKA REPORTS FINAL DATA FROM PSORIASIS STUDY
October 6, 2006
Isotechnika has announced final safety and efficacy data after 60 weeks of continuous treatment with ISA247 for psoriasis. All safety and efficacy endpoints were met. Patients completing the 24-week Canadian Phase III SPIRIT trial were given the opportunity to continue ISA247 therapy at a 0.3-mg/kg twice-daily oral dose for an additional 36 weeks. The goal of the extension trial was to gather long-term safety data while demonstrating continued therapeutic benefit.
Patients have now received continuous treatment with ISA247 for a total of 60 weeks. Over the course of the 24-week Phase III trial, patients exhibited a 60 percent mean improvement in Psoriasis Area and Severity Index (PASI) scores. After an additional 36 weeks of treatment, there was a 54 percent mean improvement in PASI scores indicating continued therapeutic benefit. This beneficial effect was still observed 12 weeks after discontinuing ISA247 treatment; mean PASI scores remained at 35 percent below pre-treatment scores.
After 60 weeks of continuous treatment, there were no clinically significant changes in kidney function, cholesterol, triglycerides, new onset diabetes, infectious complications or other laboratory parameters. This supports the long-term safety of ISA247.
KEYWORDS Drug Pipeline Alert
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