09 Nov, 2019 New Clinical Results for Lumasiran at ASN
We presented new positive efficacy results from the ongoing Phase 2 open-label extension (OLE) study of lumasiran, an investigational subcutaneously administered RNAi therapeutic in development for the treatment of primary hyperoxaluria type 1 (PH1), at the American Society of Nephrology (ASN) 2019 Annual Meeting, held November 5-10 in Washington, DC.
In the Phase 2 OLE study, continued dosing with lumasiran treatment resulted in a 76% mean maximal reduction in urinary oxalate relative to the Phase 1/2 baseline. There were no discontinuations from study treatment or drug-related serious adverse events.
We also announced the initiation of ILLUMINATE-C, a new global Phase 3 study of lumasiran that will enroll patients of all ages with advanced renal disease. The primary endpoint is percent reduction in plasma oxalate from baseline to six months, and we expect to report initial results in late 2020.