Dicerna Pharmaceuticals, Inc. announced it has completed dosing in the company’s PHYOXb 4 single-dose safety and tolerability study of its investigational candidate, nedosiran, for the treatment of primary hyperoxaluria (PH) type 3 (PH3). Nedosiran is Dicerna’s lead investigational GalXC RNAi therapy and is in development as a once-monthly subcutaneous treatment for all three known types of PH (PH1, PH2 and PH3), a family of ultra-rare, life-threatening genetic disorders that initially manifest with complications in the kidneys. The Company expects to report top-line results from this study in October 2021. The PHYOX4 trial (NCT04555486) is a randomized, placebo-controlled, double-blind, multicenter study designed to evaluate the safety and tolerability of a single subcutaneous dose of nedosiran in six patients with PH3 who have had at least one kidney stone event in the last 12 months. The study will also assess the proportion of participants achieving more than a 30% decrease from baseline in 24-hour urinary oxalate (Uox) on two consecutive visits. PHYOX4 participants who respond to treatment with nedosiran and complete the trial are also eligible to enroll in the Company’s PHYOX3 open-label extension study evaluating nedosiran’s long-term safety and efficacy in participants with PH1, PH2 or PH3. PHYOX4 is part of the broader PHYOX clinical trial program designed to evaluate nedosiran in patients with PH1, PH2 and PH3. Data from PHYOX1, a single-dose Phase 1 trial in healthy volunteers and patients with PH1 or PH2; PHYOX2, the pivotal, double-blind, placebo-controlled, six-month trial in patients with PH1 or PH2; PHYOX4; and the ongoing PHYOX3 study are expected to support the nedosiran New Drug Application (NDA) submission, which is planned for the fourth quarter of 2021.