Isotechnika Inc, an international biopharmaceutical company, reports final safety and efficacy data subsequent to 60 weeks of continuous treatment with ISA247. 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 per cent mean improvement in Psoriasis Area and Severity Index (PASI) scores. After an additional 36 weeks of treatment, there was a 54 per cent mean improvement in PASI scores indicating continued therapeutic benefit. This beneficial effect was still observed twelve weeks after discontinuing ISA247 treatment; mean PASI scores remained at 35 per cent below pre-treatment scores.
Subsequent to 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.
"The heartening experience portending a new psoriasis medication continues as the efficacy and safety are confirmed in a longer study," stated Dr. Robert Auerbach, Clinical Professor of Dermatology, New York University School of Medicine.
"We are pleased that the final 60 week data is consistent with all previously reported data on the drug," added Dr. Randall Yatscoff, Isotechnika's President & CEO. "The purpose of the extension trial was to generate longer term safety and efficacy data. All of the endpoints of this trial have been successfully achieved. In addition, the majority of patients exhibited continued therapeutic benefit subsequent to discontinuation of drug."