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Alnylam Reports Positive Results From Phase 3 Study Of Lumasiran In Primary Hyperoxaluria Type 1

Alnylam Pharmaceuticals Inc. (ALNY) announced positive results from the ILLUMINATE-C Phase 3 open-label study of lumasiran in patients of all ages with advanced primary hyperoxaluria type 1 or PH1 associated with progressive decline in renal function.

"Through the ILLUMINATE clinical program, we are hoping to establish that lumasiran may be a therapeutic option for PH1 patients regardless of age or disease severity, including patients on hemodialysis," said Jeroen Valkenburg, General Manager, Lumasiran program at Alnylam.

The company looks forward to reporting complete data from the ILLUMINATE-C study at a medical congress later this year.

Lumasiran is an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) - the gene encoding glycolate oxidase (GO) - that is being investigated for the treatment of adult and pediatric patients with advanced PH1.

Results of the primary analysis at six months demonstrated substantial reduction in plasma oxalate from baseline in both dialysis-independent and -dependent patients. Lumasiran also demonstrated positive results across key secondary endpoints, including measures of urinary oxalate and additional measures of plasma oxalate.

The company plans to submit a Supplemental New Drug Application for lumasiran with the U.S. Food and Drug Administration and a Type II Variation with the European Medicines Agency in late 2021.

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