Alnylam details successful lumasiran kidney/bladder study results

Following up on its initial announcement in December 2019, Alnylam Pharmaceuticals (NASDAQ:ALNY) releases detailed results from its successful Phase 3 clinical trial, ILLUMINATE-A, evaluating RNAi therapeutic candidate 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 data were virtually presented at the European Renal Association-European Dialysis and Transplant Association International Congress.

The study met the primary endpoint demonstrating a statistically significant 53.5% average relative reduction in urinary oxalate versus placebo and a 65.4% mean absolute reduction from baseline. All secondary endpoints were also met.

On the safety front, the most common treatment-related adverse events were mild injection site reactions.

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.

Marketing applications are currently under review in the U.S. and Europe.

https://seekingalpha.com/news/3580970-alnylam-announces-detailed-results-from-successful-lumasiran-study-in-ph1