PRX-115 promising treatment option for patients with gout, finds study

The findings suggest that PRX-115 single ascending dosages were usually well tolerated, according to key findings from the first 7 cohorts. A total of 18 associated Treatment Emergent Adverse Events (TEAEs) were reported by 11 (26%) subjects who received PRX-115; most of them were mild to moderate and temporary in character. At a modest dosage, one significant adverse event (SAE, anaphylactic response) happened right after the infusion started. The person persisted in the trial when the SAE had completely resolved.

Exposure to PRX-115 grew in a dose-dependent manner, with detectable amounts up to 85 days (12 weeks) after treatment at the high dosages and peak concentrations being recorded right after infusion. A single dosage of PRX-115 quickly lowered plasma urate below 6.0 mg/dL in all tested doses. With urate levels below 6.0 mg/dL that persisted for 12 weeks, the urate-lowering efficacy and response duration were dose-dependent.

Overall, the findings of this FIH-SAD study's first seven cohorts show that PRX-115 may be able to provide a broad dose interval and is a potentially effective therapy choice for gout patients. To validate these results and determine PRX-115's long-term safety and effectiveness in gout patients, more research is necessary.

Source:

Prolonged plasma urate-lowering after a single intravenous administration of PRX-115, a novel PEGylated uricase, in participants with elevated urate levels. (2024, October 15). ACR Meeting Abstracts. https://acrabstracts.org/abstract/prolonged-plasma-urate-lowering-after-a-single-intravenous-administration-of-prx-115-a-novel-pegylated-uricase-in-participants-with-elevated-urate-levels/