PRX-115 + Methotrexate for Gout
(RELEASE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness and safety of a new treatment called PRX-115 for people with gout, a type of arthritis caused by excess uric acid in the blood. Participants will receive different combinations of PRX-115 and methotrexate (a medication commonly used to reduce inflammation) or placebos to determine the most effective option. Those who have struggled to lower their uric acid levels despite treatment or cannot use current medications might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in gout treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PRX-115 has generally been well-tolerated in past studies. In one study, 25% of participants (12 out of 48) experienced treatment-related side effects, though the specific side effects were not detailed. The treatment effectively lowered uric acid levels, which is important for treating gout.
Methotrexate (MTX) is commonly used for conditions like arthritis. It is usually well-tolerated but can sometimes cause side effects like nausea or tiredness. This trial tests PRX-115 both with and without MTX, making it important to understand the safety of both.
Overall, earlier research has shown promising results for PRX-115 in terms of safety and effectiveness, but more studies are needed to fully confirm its long-term safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PRX-115 for gout because it introduces a new approach to treatment with its enzyme replacement therapy. Unlike traditional gout treatments like allopurinol or febuxostat, which primarily inhibit uric acid production, PRX-115 leverages a recombinant uricase, which directly breaks down uric acid in the body. This mechanism targets the root cause of gout, potentially offering a more effective reduction in uric acid levels. Additionally, the administration of PRX-115 via intravenous infusion could provide more predictable dosing and effectiveness compared to oral medications, which may be influenced by individual absorption differences.
What evidence suggests that this trial's treatments could be effective for gout?
Research has shown that PRX-115 may help treat gout by lowering uric acid levels in the blood. One study demonstrated that a single dose of PRX-115 quickly reduced uric acid to below 6.0 mg/dL, with the effect lasting depending on the dose. PRX-115 was generally well-tolerated, with mostly mild side effects. In this trial, participants will receive PRX-115 with Methotrexate (MTX) or placebo-MTX, or they will receive a placebo version of PRX-115. These findings suggest that PRX-115 could effectively manage gout symptoms.12678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple IV infusions of PRX-115 with or without methotrexate over 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Methotrexate (MTX)
- Placebo-Methotrexate
- PRX-115
- PRX-115 placebo
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
IV infusion of PRX-115 every 8 weeks (E8W) for a total of 3 doses with MTX
IV infusion of PRX-115 every 6 weeks (E6W) for a total of 4 doses with MTX
IV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with placebo-MTX
IV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with MTX
infusion of PRX-115 placebo every 4 weeks (E4W) for a total of 6 doses with placebo-MTX
IV infusion of PRX-115 placebo every 6 weeks (E6W) for a total of 4 doses with placebo-MTX
Find a Clinic Near You
Who Is Running the Clinical Trial?
Protalix
Lead Sponsor
Citations
PRX-115
Pre-clinical data demonstrates long half-life, reduced immunogenic risk and high specific activity which supports the potential of PRX-115 to be a safe and ...
Prolonged Plasma Urate-Lowering After a Single ...
A single dose of PRX-115 rapidly reduced plasma urate below 6.0 mg/dL. The urate-lowering effect and the duration of the response were dose-dependent.
Protalix BioTherapeutics Reports Fiscal Year 2024 ...
Further studies are needed to confirm the long-term safety and efficacy of PRX-115 in the gout patient population. The results were ...
4.
trial.medpath.com
trial.medpath.com/news/9c99f83ebd5d0b3f/protalix-biotherapeutics-to-present-phase-i-prx-115-data-in-late-breaking-poster-at-acrProtalix Bio Presents Positive Phase 1 Data for PRX-115 in ...
The results indicated that a single intravenous dose of PRX-115 led to a sustained reduction in plasma urateSearch term levels. The abstract ( ...
Protalix BioTherapeutics Reports Fiscal Year 2025 ...
The RELEASE study builds on favorable Phase 1 clinical trial results, where PRX–115 was generally well–tolerated and demonstrated rapid, durable ...
A Study to Investigate the Clinical Effect and the Safety ...
This study will evaluate the efficacy, safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PRX-115 (a ...
7.
trial.medpath.com
trial.medpath.com/news/protalix-s-prx-115-shows-promise-in-phase-i-gout-trial-with-extended-dosing-potentialProtalix's PRX-115 Shows Promise in Phase I Gout Trial with ...
Safety data showed PRX-115 to be generally well-tolerated, with 25% of treated subjects (12/48) reporting study drug-related adverse events.
8.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/PLX/pressreleases/446728/protalix-advances-release-gout-trial-sharpening-its-long-term-biotech-upside/Protalix Advances RELEASE Gout Trial, Sharpening Its ...
The treatment being tested is PRX-115, an infused biologic drug designed to lower uric acid and reduce gout burden. It is given alone or ...
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