14 May, 2021 Complete Results from Phase 1/2 Study of Lumasiran (OXLUMO®) Published in Clinical Journal of the American Society of Nephrology
Complete results from the Phase 1/2 study of lumasiran for the treatment of primary hyperoxaluria type 1 (PH1) were published in the Clinical Journal of the American Society of Nephrology. The final results demonstrated an acceptable safety profile of OXLUMO in adult and pediatric patients. The majority of adverse events were mild or moderate; there were no serious adverse events considered to be drug-related and no adverse events led to death, study discontinuations or study withdrawals. After treatment with lumasiran, all 20 lumasiran-treated patients exhibited near-normal1 levels of 24-hour urinary oxalate excretion, with majority of such patients achieving levels within the normal2 range.
These data were previously presented at the 2019 Oxalosis & Hyperoxaluria International Workshop, held June 21-22, 2019 in Boston.
Read the paper in Clinical Journal of the American Society of Nephrology.
- Near-normal is defined as ≤1.5 times upper limit of normal or ULN (≤0.69 mmol/24 h per 1.73 m2)
- Normal is defined as ULN (≤0.46 mmol/24 h per 1.73 m2)