Alnylam Pharmaceuticals (NASDAQ:ALNY) is up 6% premarket on light volume in reaction to positive results from a Phase 3 clinical trial, ILLUMINATE-A, evaluating lumasiran in patients with primary hyperoxaluria type 1 (PH1), a rare inherited disorder characterized by kidney and bladder stones caused by excess levels of oxalate in the kidneys and urinary tract.
The 30-subject study met the primary and all secondary endpoints.
Results from another Phase 3, ILLUMINATE-B, should be available in mid-2020. A third Phase 3, ILLUMINATE-C, should launch in 2021.
The company plans to file a marketing applications in the U.S. and Europe in early 2020.
Lumasiran is designed to reduce oxalate in the body by reducing the levels of an enzyme called glycolate oxidase which depletes the substrate necessary for oxalate production. It has Breakthrough Therapy status in the U.S. and PRIME status in Europe for the indication.
A conference call will begin momentarily.
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