Varespladib for Snake Bites
(BRAVIO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes.Note: Funding Source - FDA-OOPD
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking all current medications. However, you cannot participate if you are using certain anticoagulants or antiarrhythmic drugs within 14 days before treatment.
What safety data exists for Varespladib as a treatment?
Varespladib has been evaluated in 29 clinical studies involving over 4600 human subjects for non-snakebite conditions, where it was generally well-tolerated and considered safe. It is currently in Phase 2 clinical trials for snakebite treatment. Preclinical studies and animal models have shown promising results in inhibiting snake venom toxicity.12345
Is the drug Varespladib a promising treatment for snake bites?
Yes, Varespladib is a promising drug for treating snake bites. It works by blocking a key component in snake venom called phospholipase A2 (PLA2), which is responsible for many of the harmful effects of the venom. Studies have shown that Varespladib can effectively reduce the toxic effects of snake venom, improve survival rates in animal models, and potentially serve as a first-line treatment for snakebite envenomation.23456
What data supports the idea that Varespladib for Snake Bites is an effective drug?
The available research shows that Varespladib is effective in treating snake bites by inhibiting a key venom component called phospholipase A2 (PLA2). In one study, 80% of mice treated with Varespladib and venom survived, while all mice given venom alone died. Another study found that Varespladib significantly reduced muscle damage and other toxic effects in animal models. These results suggest that Varespladib could be a promising alternative or addition to traditional antivenom treatments.12345
Who Is on the Research Team?
Timothy Platts-Mills, MD, MSc
Principal Investigator
Ophirex, Inc.
Are You a Good Fit for This Trial?
Adults (18+) with a venomous snakebite within the last 10 hours can join this trial. They must have certain symptoms measured by an inclusion score and agree to informed consent. People with severe heart, bleeding, or liver conditions, kidney disease, allergies to varespladib, on certain anticoagulants or antiarrhythmics recently, pregnant or breastfeeding women cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous infusion of varespladib or placebo followed by transition to oral dosing
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Complete recovery assessment using the Snakebite Severity Scale Score
What Are the Treatments Tested in This Trial?
Interventions
- Varespladib
Varespladib is already approved in United States, India for the following indications:
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Who Is Running the Clinical Trial?
Ophirex, Inc.
Lead Sponsor