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June 10, 2022

Alnylam reports positive Phase II immunoglobulin A nephropathy data

In the trial, cemdisiran offered a 37% mean decline from baseline in the 24-hour urine protein to creatinine ratio versus placebo.

Alnylam Pharmaceuticals has reported topline data from the Phase II clinical trial of investigational ribonucleic acid interference (RNAi) therapeutic, cemdisiran (ALN-CC5), to treat immunoglobulin A nephropathy (IgAN). 

Acting on the C5 component of the complement pathway, cemdisiran is being developed in partnership with Regeneron Pharmaceuticals.

The double-blind, randomised, multicentre, placebo-controlled trial analysed the safety and efficacy of cemdisiran in adult IgAN patients. 

It enrolled 31 adults aged between 18 and 65 years and categorised them into a 2:1 ratio to receive cemdisiran or placebo. 

According to the findings, at week 32, cemdisiran offered a 37% mean decline from baseline in the 24-hour urine protein to creatinine ratio versus placebo, the trial’s primary endpoint and a key prognostic marker of progression of the disease. 

Measures of proteinuria, variation in hematuria, percent of subjects with partial clinical remission and frequency of adverse events were included as the trial’s secondary endpoints.

The results of secondary endpoints were in line with cemdisiran’s therapeutic benefit in IgAN. 

No serious or severe adverse events (AEs) linked to the drug or any substantial drug-associated safety signals were reported in the trial. 

The overall safety and tolerability profile of cemdisiran support the continued clinical development of the drug.

Alnylam Pharmaceuticals Cemdisiran programme vice-president and programme leader Sonalee Agarwal said: “We are encouraged by these topline results with cemdisiran demonstrating what we believe to be clinically meaningful reductions in proteinuria – an important prognostic factor in IgA nephropathy.

“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 IIII clinical development of cemdisiran.”

In December last year, the company initiated a Phase II trial of lumasiran in people with recurrent kidney stone disease and higher urinary oxalate levels.

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