Shots:
- The PHYOX4 study evaluates nedosiran (SC) vs PBO in patients with PH3 who had 1 kidney stone event in the prior 12mos.
- The study met its primary safety EPs i.e., the therapy is safe & well tolerated. The trial did not meet prespecified secondary efficacy EPs of ≥30% decrease from baseline in 24-hrs. Uox excretion on two consecutive visits over 3mos. observation period., no serious AEs were reported & results were consistent with previously reported studies in the PHYOX clinical development program
- The company plan to submit an NDA to the US FDA for nedosiran to treat PH1 in Q4’21. The therapy is designed to inhibit the production of hepatic LDH enzyme that leads to oxalate overproduction
Click here to read the full press release/ article | Ref: Dicerna | Image: Businesswire
The post Dicerna Reports Results of Nedosiran in PHYOX4 Study for the Treatment of Primary Hyperoxaluria Type 3 first appeared on PharmaShots.
