140 Participants Needed

Varespladib for Snake Bites

(BRAVIO Trial)

Recruiting at 10 trial locations
BR
Overseen ByBrandi Ritter PA-C, MPAS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

TP

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

I was bitten by a Russell's viper or krait in India.
This criterion does not apply to me.
In the U.S., any snakebite that meets all other criteria may be eligible
See 5 more

Exclusion Criteria

I have a history of chronic liver disease.
Known allergy or significant adverse reaction to varespladib or varespladib-methyl
Considered by the Investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous infusion of varespladib or placebo followed by transition to oral dosing

14 days
Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

Extended Follow-up

Complete recovery assessment using the Snakebite Severity Scale Score

28 days

What Are the Treatments Tested in This Trial?

Interventions

  • Varespladib
Trial Overview The BRAVIO study is testing IV varespladib followed by oral varespladib-methyl against placebos in addition to standard care for snakebites. It's a phase 2 trial where participants are randomly assigned treatments in a double-blind manner so neither they nor the researchers know who gets what.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Varespladib Intravenous Form (IV) + Varespladib Oral tablet (LY315920) + SOCExperimental Treatment2 Interventions
Group II: Placebo Intravenous (IV) + Placebo Oral + SOCActive Control2 Interventions

Varespladib is already approved in United States, India for the following indications:

🇺🇸
Approved in United States as Varespladib for:
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Approved in India as Varespladib for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ophirex, Inc.

Lead Sponsor

Trials
3
Recruited
250+

Published Research Related to This Trial

Varespladib effectively inhibits the toxic effects of snake venom phospholipase A₂, showing significant protective effects against hemorrhage and muscle damage in animal models of envenomation.
In studies with mice, varespladib treatment significantly reduced muscle edema and biochemical markers of organ injury, suggesting it could be a promising first-line treatment for snakebite envenomation.
Exploration of the Inhibitory Potential of Varespladib for Snakebite Envenomation.Wang, Y., Zhang, J., Zhang, D., et al.[2022]
Varespladib has been shown to effectively inhibit the myotoxic and cytotoxic effects of the snake venom component MjTX-I, suggesting its potential as a complementary treatment alongside traditional antivenoms.
The study utilized advanced techniques like X-ray crystallography and mass spectroscopy to reveal the unique inhibitory mechanism of varespladib, indicating it may serve as a multifunctional inhibitor for various PLA2 and PLA2-like toxins.
The synthetic varespladib molecule is a multi-functional inhibitor for PLA2 and PLA2-like ophidic toxins.Salvador, GHM., Borges, RJ., Lomonte, B., et al.[2021]
The BRAVO study is a phase 2 clinical trial designed to evaluate the safety and efficacy of varespladib-methyl, an oral treatment for snakebite envenoming, involving patients aged 5 and older from various geographic locations.
The primary outcome of the study is the modified Snakebite Severity Score, which assesses the impact of snake venom on multiple body systems, indicating a comprehensive approach to evaluating the treatment's effectiveness.
The BRAVO Clinical Study Protocol: Oral Varespladib for Inhibition of Secretory Phospholipase A2 in the Treatment of Snakebite Envenoming.Carter, RW., Gerardo, CJ., Samuel, SP., et al.[2023]

Citations

Exploration of the Inhibitory Potential of Varespladib for Snakebite Envenomation. [2022]
The synthetic varespladib molecule is a multi-functional inhibitor for PLA2 and PLA2-like ophidic toxins. [2021]
The BRAVO Clinical Study Protocol: Oral Varespladib for Inhibition of Secretory Phospholipase A2 in the Treatment of Snakebite Envenoming. [2023]
PLA2 Inhibitor Varespladib as an Alternative to the Antivenom Treatment for Bites from Nikolsky's Viper Vipera berus nikolskii. [2021]
Varespladib in the Treatment of Snakebite Envenoming: Development History and Preclinical Evidence Supporting Advancement to Clinical Trials in Patients Bitten by Venomous Snakes. [2023]
Varespladib (LY315920) and Methyl Varespladib (LY333013) Abrogate or Delay Lethality Induced by Presynaptically Acting Neurotoxic Snake Venoms. [2021]
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