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Dicerna Posts Mixed Nedosiran Data In Rare Kidney Disease Trial

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  • Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) has announced top-line results from its PHYOX4 study of nedosiran for primary hyperoxaluria type 3 (PH3).

  • Related: Why Is Dicerna Stock Getting Slammed Today?

  • Nedosiran demonstrated safety and tolerability results consistent with previously reported studies.

  • Patients administered nedosiran also showed a trend in urinary oxalate (Uox) reduction; however, these reductions did not meet prespecified secondary efficacy endpoint criteria.

  • Dicerna plans to submit an FDA marketing application for nedosiran to treat PH1 in Q4 of 2021.

  • No subjects in either group achieved the prespecified secondary efficacy endpoint, a greater than 30% decrease from baseline in 24-hour Uox excretion on at least two consecutive visits over the three-month observation period.

  • However, all patients administered a single dose of nedosiran demonstrated Uox reductions relative to baseline at one or more time points during the three months.

  • Primary hyperoxaluria (PH) is a family of ultra-rare, life-threatening genetic disorders that initially manifest with complications in the kidneys.

  • Price Action: DRNA shares are up 1.73% at $21.15 during the market session on the last check Tuesday.

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