Alnylam initiates Phase 3 study of lumasiran, reports 'positive' Phase 2 data
Alnylam Pharmaceuticals announced that the company has initiated ILLUMINATE-C, a new global Phase 3 study of lumasiran, an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of primary hyperoxaluria type 1. The study will enroll patients of all ages with advanced renal disease, and the primary study endpoint is the percent reduction in plasma oxalate from baseline to six months. Alnylam expects to report initial ILLUMINATE-C results in late 2020. The company also announced new positive efficacy results from the ongoing Phase 2 open-label extension study of lumasiran, which were presented at the American Society of Nephrology 2019 Annual Meeting on Saturday, November 9. Pritesh Gandhi, PharmD, VP and General Manager, Lumasiran program at Alnylam. "We are also pleased to report new results from our Phase 2 OLE study, and are encouraged by the sustained reductions in urinary oxalate and by the overall safety profile of lumasiran observed to date."