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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Velvet Ice Cream recalled certain lots of its 56 oz Raspberry Fudge Cordial Ice Cream for potentially containing undeclared peanuts, the U.S. Food and Drug Administration or FDA said in a statement. The recall was initiated after it was notified of the issue by a single customer and has since learned that the cause of the error has been traced to a third-party manufacturer packaging error. Willard, Ohio-based Buurma Farms Inc. is recalling 320 boxes of its Plain Parsley citing possible contamination with Shiga-toxin producing E.coli, the U.S. Food and Drug Administration said. The recall involves Buurma Plain (flat leaf) Parsley with a harvest date of August 30, 2021 from their Gregory, Michigan location. Molson Coors Beverage Co. is bringing Topo Chico Hard Seltzer, the sparkling mineral water, across the United States starting January 2022. The company will officially expand the distribution of the product, which was launched last spring in nine states and seven metro areas, to all 50 states. Molson Coors is manufacturing, marketing and distributing Topo Chico Hard Seltzer in the U.S.
Follow RTT