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LPCN Awaits FDA Word, NKTR On Track, All's Well With Five Prime's FPT155

(RTTNews) - Today's Daily Dose brings you news about Alnylam's new positive efficacy results from its ongoing phase II open-label extension (OLE) study of Lumasiran for the treatment of primary hyperoxaluria type; Five Prime's initial safety data from its phase I clinical trial of FPT155 in patients with advanced solid tumors; Lipocine's much-awaited catalyst; Mirati's initial efficacy data from a phase II trial of Sitravatinib in metastatic urothelial cancer patients and Nektar's 18-month follow-up data from its PIVOT-02 study.

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Alnylam Pharmaceuticals Inc. (ALNY) announced new positive efficacy results from its ongoing phase II open-label extension (OLE) study of Lumasiran for the treatment of primary hyperoxaluria type 1.

Primary hyperoxaluria type 1 (PH1) is a rare disorder that mainly affects the kidneys. It results from the buildup of a substance called oxalate, which normally is filtered through the kidneys and excreted in the urine (Source: NIH).

The open-label extension phase II study of Lumasiran demonstrated a 76 percent mean maximal reduction in urinary oxalate excretion, with all patients achieving a urinary oxalate level at or below 1.5 times the upper limit of normal, and 68 percent of patients achieving a urinary oxalate level within the normal range (less than or equal to 0.46 mmol/24hr/1.73m2).
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