PR Newswire·Nov 9, 2026, 6:45 AM ET

Higher Single PRX-115 Doses Kept Plasma Uric Acid Levels Below Therapeutic Target for Longer Durations

Protalix BioTherapeutics presented Phase 1 data at ACR Convergence 2026 supporting less frequent dosing for PRX-115 in uncontrolled gout.
Individual patient data showed PRX-115 plasma levels remained measurable for up to 85 days after single high-dose infusions.
In the Phase 1 study, a 36 mg dose lowered mean plasma uric acid below the 6.0 mg/dL target for up to 12 weeks.
The upcoming Phase 2 RELEASE study will test dosing every four weeks without methotrexate or every eight weeks with methotrexate.
Top-line results for the Phase 2 RELEASE study are expected in the second half of 2027.
PRX-115 is a plant cell-expressed recombinant PEGylated uricase designed to reduce infusion burden, immunogenicity, & safety concerns compared to current therapies.
Phase 1 safety data indicated PRX-115 was generally well-tolerated, with mostly mild to moderate adverse events & one resolved anaphylactic reaction.
The presentation details include Abstract Number 2652 in Poster Session C on November 10, 2026.
Uncontrolled gout affects approximately 180,000 patients in the U.S. & is characterized by severe pain, high morbidity, & low quality of life.