recombinant PEGylated uricase (PRX-115) / Protalix - LARVOL DELTA

A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE) (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Protalix

New P2 trial • Gout • Inflammatory Arthritis • Rheumatology

Updates in uricase therapy for gout. (PubMed, Curr Opin Rheumatol) - "Exogenous uricases available and those under development are discussed, focusing on immunomodulation and anti-inflammatory prophylaxis to reduce flares, prevent antidrug antibody formation and infusion reactions, and mitigate loss of efficacy in patients with uncontrolled gout needing uricase replacement therapy."

Journal • Developmental Disorders • Gout • Immunology • Inflammatory Arthritis • Oncology • Rheumatology

A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers with Elevated Uric Acid Levels (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Protalix | Recruiting ➔ Completed

Trial completion • Gout • Inflammatory Arthritis • Rheumatology

Prolonged Plasma Urate-Lowering After a Single Intravenous Administration of PRX-115, a Novel PEGylated Uricase, in Participants with Elevated Urate Levels (ACR Convergence 2024) - P1 | "The results from the initial seven cohorts of this FIH-SAD study demonstrate that PRX-115 has the potential to be a promising treatment option for patients with gout, and may be able to offer a wide dosing interval. Further studies are warranted to confirm these findings and to establish the long-term safety and efficacy of PRX-115 in gout patients."

Late-breaking abstract • Gout • Inflammatory Arthritis • Rheumatology

Characteristics and Management of Uncontrolled Gout Prior to Pegloticase Therapy: A 2-year Claims Analysis. (PubMed, Rheumatol Ther) - "Patients with uncontrolled gout experienced an increase in the clinical burden of disease and HCRU in the 2 years before the initiation of pegloticase. Earlier patient identification and initiation of potentially effective therapy may help alleviate these burdens."

Journal • Gout • Immunology • Inflammatory Arthritis • Pain • Rheumatology

A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Protalix | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Protalix

Trial completion date • Trial primary completion date • Gout • Inflammatory Arthritis • Rheumatology

Oral Urate-Lowering Therapy Use and Efficacy Following Pegloticase Treatment: Findings from a Rheumatology Network Database (ACR Convergence 2023) - "Background/Purpose: Pegloticase, a recombinant pegylated uricase, rapidly reduces serum urate (SU) in patients refractory to/intolerant of oral urate-lowering therapies (ULTs)...141 patients (67%) had pre-pegloticase oral ULT use noted (73% allopurinol, 48% febuxostat, and/or 18% probenecid)... These pegloticase-treated patients reflected a typical uncontrolled gout population. Two-thirds of patients began oral ULT after pegloticase, most within 30 days of last infusion. Patients who had a longer pegloticase course (=12 infusions) were more likely to have post-treatment oral ULT efficacy, perhaps because of greater urate burden depletion."

Clinical • Gout • Inflammatory Arthritis • Rheumatology

A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Protalix | Not yet recruiting ➔ Recruiting

Enrollment open • Gout • Inflammatory Arthritis • Rheumatology

A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Protalix

New P1 trial • Gout • Inflammatory Arthritis • Rheumatology