Voclosporin (ISA247) psoriasis trial shows impressive results
A Canadian Phase Three trial of Voclosporin (ISA247) in patients with moderate to severe plaque psoriasis showed promising results, the British medical journal The Lancet is reporting. The drug is made by Isotechnika, based in Canada.
Voclosporin is designed to be, the company hopes, a safer alternative to cyclosporine, which is highly effective in treating serious psoriasis but that usually causes kidney damage that limits the duration of its use to months, or one or two years.
In the study, nearly half of the patients receiving the biggest dose of Voclosporin/ISA247 achieved a 75% improvement in psoriasis symptoms at week 12 (the standard test demanded by the US Food and Drug Administration), and effectiveness was maintained through week 24. The safety profile was considered strong by the study's authors, again through week 24, although there was some "mild to moderate glomerular filtration rate reductions" in some patients, a reduction in kidney function that can prove serious. This will have to be watched closely in future studies, and in longer dosing regimens.
Voclosporin is currently in a head-to-head study against cyclosporine, comparing its safety and effectiveness. If the new drug proves safer on the kidneys than cyclosporine while able to improve psoriasis similarly for many patients, it will be a promising new treatment option for psoriasis patients. (So far, it appears cyclosporine may clear more patients more thoroughly than ISA247, but if the trade-off is more serious side-effects, patients and their physicians may choose to try ISA247.) Voclosporin is taken in pill form, and is, like cyclosporine, a calcineurin inhibitor (CNi). There are also suggestions that Voclosporin may be priced less expensively than some of the new biologic psoriasis treatments, but that won't be known unless and until it receives FDA approval.
Voclosporin is designed to be, the company hopes, a safer alternative to cyclosporine, which is highly effective in treating serious psoriasis but that usually causes kidney damage that limits the duration of its use to months, or one or two years.
In the study, nearly half of the patients receiving the biggest dose of Voclosporin/ISA247 achieved a 75% improvement in psoriasis symptoms at week 12 (the standard test demanded by the US Food and Drug Administration), and effectiveness was maintained through week 24. The safety profile was considered strong by the study's authors, again through week 24, although there was some "mild to moderate glomerular filtration rate reductions" in some patients, a reduction in kidney function that can prove serious. This will have to be watched closely in future studies, and in longer dosing regimens.
Voclosporin is currently in a head-to-head study against cyclosporine, comparing its safety and effectiveness. If the new drug proves safer on the kidneys than cyclosporine while able to improve psoriasis similarly for many patients, it will be a promising new treatment option for psoriasis patients. (So far, it appears cyclosporine may clear more patients more thoroughly than ISA247, but if the trade-off is more serious side-effects, patients and their physicians may choose to try ISA247.) Voclosporin is taken in pill form, and is, like cyclosporine, a calcineurin inhibitor (CNi). There are also suggestions that Voclosporin may be priced less expensively than some of the new biologic psoriasis treatments, but that won't be known unless and until it receives FDA approval.
posted by Psoriasis Cure Now at 9:14 AM
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