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- Topline Results Expected in Mid-2021 -
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it has achieved full patient enrollment in its ILLUMINATE-C Phase 3 study of lumasiran, an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – for the treatment of adults and children with advanced primary hyperoxaluria type 1 (PH1). Enrollment was completed with 21 PH1 patients across 13 sites in 10 countries.
“We are pleased to have completed enrollment in the ILLUMINATE-C Phase 3 study,” said Pritesh J. Gandhi, PharmD., Vice President and General Manager, Lumasiran Program at Alnylam. “This is an important milestone to help evaluate the efficacy and safety of lumasiran in patients with advanced PH1 including those experiencing systemic oxalosis and undergoing hemodialysis. We believe lumasiran has the potential to address the full spectrum of PH1 disease severity and look forward to reporting topline results from this important study in mid-2021.”
Lumasiran was recently approved by the FDA for the treatment of PH1 to lower urinary oxalate levels in pediatric and adult patients. It was also recently approved by the EMA for the treatment of PH1 in all age groups. Lumasiran is marketed in the U.S. and EU as OXLUMO™.
About ILLUMINATE-C Phase 3 Study
ILLUMINATE-C (NCT04152200) is a single arm, open-label, multinational Phase 3 study to evaluate the safety and efficacy of lumasiran in PH1 patients of all ages and advanced renal disease (eGFR ≤ 45 mL/min/1.73m2 or elevated serum creatinine for patients
