By Michael Dabaie


Alnylam Pharmaceuticals Inc. said that results were positive from the Phase 2 study of cemdisiran for immunoglobulin A nephropathy, and that it is planning for Phase 3 development.

At Week 32, treatment with cemdisiran resulted in a 37% mean reduction from baseline in the 24-hour urine protein to creatinine ratio relative to placebo. The company said this was the primary objective of the study and an important marker of disease progression.

IgAN is the most common inflammatory disease affecting the glomerulus of the kidney often progressing to kidney failure, Alnylam said.

Alnylam said cemdisiran is in development in collaboration with Regeneron Pharmaceuticals Inc.

The results of secondary endpoints were also consistent with a therapeutic benefit of cemdisiran in IgAN, the company said. There were no significant drug-related safety signals.

The company said the efficacy and safety data support continued clinical development of cemdisiran monotherapy in patients with IgAN.

"Given the limited treatment options and significant unmet need in IgAN, we, together with our partners at Regeneron, are formulating our plans for the Phase 3 clinical development of cemdisiran," Sonalee Agarwal, vice president and program leader for the cemdisiran program at Alnylam, said.


Write to Michael Dabaie at michael.dabaie@wsj.com


(END) Dow Jones Newswires

06-09-22 0754ET