Protalix reports dose-duration data for PRX-115 in uncontrolled gout
Protalix BioTherapeutics presented Phase 1 pharmacokinetic and pharmacodynamic findings for PRX-115 at the 2026 American College of Rheumatology meeting. Across 18 participants receiving single infusions of 18 mg, 24 mg or 36 mg, drug exposure lasted longer at higher doses, while uric-acid reduction persisted correspondingly longer. At 36 mg, the average uric-acid measurement remained under 6.0 mg/dL through week 12, and Protalix expects Phase 2 RELEASE results during the second half of 2027.
Why it matters
The findings support testing less-frequent dosing in the ongoing Phase 2 RELEASE trial, which compares four- and eight-week schedules with different methotrexate regimens. Protalix says the approach could reduce infusion burden, but the Phase 2 efficacy readout is still pending.
Key facts
- 1The Phase 1 analysis covered 18 participants in the 18 mg, 24 mg and 36 mg cohorts, with each participant followed for 85 days after one infusion. investing.com
- 2At 36 mg, the cohort's average plasma uric-acid level stayed below 6.0 mg/dL through 12 weeks after administration. prnewswire.com
- 3The Phase 2 RELEASE study uses five treatment arms of 30 patients each and tests a fixed 36 mg dose given at intervals ranging from every 4 weeks to every 8 weeks, alongside placebo. prnewswire.com
- 4Phase 2 RELEASE top-line results are expected in the second half of 2027. prnewswire.com
- 5Phase 1 safety findings included one resolved anaphylactic reaction, while no other serious adverse events were reported. prnewswire.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.